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  • Posted: Apr 1, 2022
    Deadline: Not specified
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  • Sharing a Vision to Drive Healthcare Forward Healthcare is an industry designed to help humans. As a global community, we continuously invest and commit to advancing human health. To deliver value and real outcomes. To rise to the challenge to find the next breakthrough by making the most of increasingly limited resources. We are inspired by the potential ...
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    Contracting Specialist, Real World Evidence, EMEA

    Job Overview
    Coordinate and manage commercial contracts for assigned customers/part of the business.Act as the regional expert on contracting process, drive process implementation and continuous improvements to efficiently produce compliant, accurate and timely deliverables.

    Essential Functions

    • Manage the day-to-day tasks related to contract development and processes for large complex contracts.
    • Work closely with project teams, legal and finance to determine appropriate scope, terms and conditions of contracts
    • Customize documents to accurately reflect services in scope. Oversee finalization and distribution of documents
    • Act as regional expert on contracting and designated processes and be the key interface for assigned (mostly internal) customers, ensuring consistency in approach, metrics and format.
    • On occasions participate in client meetings related to the contracting process with client project teams and procurement etc.
    • Proactively seek to clear questions, obstacles or discrepancies, propose solutions based on expertise.
    • Ability and willingness to work independently with minimal oversight
    • Provide advice, support and guidance as needed and serve as a mentor to colleagues.
    • Perform other duties as assigned.
    • Develop understanding of IQVIA corporate goals and be compliant to corporate policies

    Qualifications

    • Bachelor's Degree Bachelor's Degree in Business Management, Life Science, or relevant field
    • 3-5 years of experience from working with commercial contracts, compliance governance or proposals or equivalent combination of education, training, and experience
    • Excellent knowledge of Microsoft Excel, Word and understanding of costing models.
    • Ability to interpret budgets and project scope/protocols.
    • Knowledge of CRO Industry is a merit.
    • Possess strong analytical skills and excellent verbal and written communication skills.
    • Ability to establish and maintain effective working relationships with coworkers, managers and customers.

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    Clinical Data Specialist

    JOB DESCRIPTION
    PURPOSE  
     

    Provide basic and some comprehensive data management expertise to the Clinical Data Management team to provide efficient, quality data management products that meet customer needs. May also undertake team leadership activities under the supervision of the Data Operations Coordinator, Data Team Lead, or Functional Manager.   

    RESPONSIBILITIES

    • Serve as a Data Operations Coordinator (DOC) for one protocol with less than 5 operations staff (excludes DE) or 15+ easy to moderately complex central laboratory studies, or serve in a leadership role in a specific data management task (e.g., coder, tester or database designer for technologies that don't require extensive programming expertise) with guidance.
    • May serve in the role of back-up to a Data Operations Coordinator or Data Team Lead.
    • May conduct data review.
    • May write and resolve data clarifications.
    • May lead database audit team.
    • May develop and test databases and edit specifications.
    • May perform testing of programming.
    • May perform clinical data coding.
    • Understand and comply with core operating procedures and working instructions.
    • Meet objectives as assigned.
    • Develop and maintain good communications and working relationships with CDM team.

    REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

    • Medical terminology exposure   
    • Excellent organizational, communication, leadership and computer skills   
    • Ability to exercise excellent attention to detail   
    • Ability to act independently and with initiative required to resolving problems   
    • Ability to establish and maintain effective working relationships with co-workers, managers and clients   

    MINIMUM REQUIRED EDUCATION AND EXPERIENCE

    • Bachelor’s degree, or educational equivalence, in clinical, biological or mathematical sciences, or related field; or equivalent combination of education, training and experience with 1 – 2 years of prior relevant experience

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    Client Services Lead, Clinical Trial Payments (Bloemfontein SA)

    We are looking for a dedicated Client Services Lead located in Bloemfontein, South Africa, to be part of the Clinical Trial Payments unit in IQVIA. This position will have the option to work fully remote or from the office.

    This position will work as part of the Clinical Trial Payments unit. It uses the most advanced site payment solution available and offers service to customers to integrate/centralize all payments in a high tech software.

    The Client Services Lead is responsible for ensuring clients obtain maximum value from products and services in order to facilitate a positive and productive long-term relationship, either broad client or offering focused.

    Essential Functions:

    • Ensures fulfillment of contract specifications and ad-hoc client requests to build client satisfaction, under supervision.
    • Assists team members to build, establish and maintain effective business relationships with clients to proactively support their needs as their day-to-day contact, possibly focused on a specific product or service.
    • Ensures, through review and verification, that the product deliverable meets the customer's specifications, including timeliness and quality.
    • Partners with the account manager and clients to derive optimum value from IQVIA products and services by explaining and expanding the usage of current IQVIA deliverables and identifying revenue opportunities within existing clients.
    • Maintains effective internal communications with sales and client service support to keep all apprised on activities with the client.
    • Monitors performance against existing service agreements and ensures client’s obligations are met.
    • Researches, analyzes and responds to client that require an in-depth understanding of the client, specific business line, and/or therapeutic market.
    • May conduct product/services and process training for clients and other employees.
    • May conduct service meetings at client sites.
    • May mentor and lead other client service reps and represent the manager in their absence.

    Our Ideal Candidate Will Have:

    • Bachelor's Degree required.
    • •+ 4 years of related work experience in finance, banking or project management.
    • Proficiency in Office tools applications, such as Excel and Power Point.
    • Fluent English skills is a must and any other language will be considered as a plus.
    • Broad knowledge of the concepts, practices and procedures of the client service representative field.
    • Ability to communicate effectively with various levels in the organization (written and oral) and to manipulate large transactional databases.
    • Demonstrated problem solving, analytical and strong customer service skills.
    • Knowledge of the pharmaceutical, CRO, life sciences or healthcare industry will be considered as a plus.

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    Snr Database Programmer

    JOB DESCRIPTION
    Job Overview:

    • Under broad guidance, performs activities related to the analysis, design, programming, debugging, modification, and maintenance of software enhancements and/or new products.

    Essential Functions

    • Under broad guidance, analyzes, designs, programs, debugs, modifies, and maintains software enhancements and/or new products used in local, networked, or Internet-related computer programs.
    • Under broad guidance, may interact with users to define system requirements and/or necessary modifications.
    • Prepares feasibility studies to evaluate requirements for new and revised programs.
    • Translates detailed design specifications into computer program instructions, debugs routine programs, prepares system test data and prepares program documentation.
    • Completes documentation and procedures for installation and maintenance.
    • Code may be used in commercial or end-user applications, such as desktop applications, mobile apps, financial management, or HRIS products.
    • Using current programming language and technologies, writes code, completes programming, and performs testing and debugging of applications.

    Qualifications:

    • Bachelor's Degree Computer Science or related discipline
    • Incumbent possesses and has demonstrated basic knowledge of systems and software development with a minimum of two (2) years of software development experience.
    • Lead the building of a dedicated, enthusiastic team of software developers and engineers.
    • Collaborate closely with developers and data scientists.
    • Build and own your team’s roadmap, ensuring alignment with stakeholders in data-science and consulting functions.
    • Promote best-practice software development and related technologies and participate in the full software lifecycle.
    • Lead agile practices such as daily stand ups, sprint planning, sprint refinements, and retrospectives; work to fortnightly sprints and organize bi-weekly demos across multiple teams.
    • Deliver development reports, milestones and delivery schedules to the business.
    • Work alongside other team members such as Product Owners and Software QA to manage the development cycle from ‘thought to delivery'.

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    Client Service Manager

    JOB DESCRIPTION

    • Manages client expectations and ensures the delivery of business services, products and solutions to ensure client satisfaction, retention and brand preservation.
    • Takes responsibility for the quality of service delivered to clients, ensuring clients obtain maximum value from products and services. Answers client queries and collaborates with production to get data in client-desired formats.
    • May lead projects between business and client teams; develop translatable client action plans with internal teams (i.e. responsibilities, timeframes, and resources); provide in-depth training in databases and products, and assist with pricing products.
    • Under guidance, controls the report generation process and provides guidance and support to clients daily or as a specialist on specific products/services.

    Responsibilities

    Essential Functions

    • Ensures the contract fulfillment to specifications of basic and routine reports for defined customers.
    • Reviews client data requirements with the appropriate internal resource to ensure that basic product deliverables meet the customer's specifications, including timeliness and quality.
    • Follows IQVIA data verification protocols.
    • Researches, analyzes and responds to client inquiries that are routine in nature.
    • Provides support to team for client service meetings at customer sites.
    • May produce ad-hoc studies on demand.

    Experience

    • Typically requires 0 - 2 years of prior relevant experience.

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    Operations Analyst 2

    JOB DESCRIPTION
    Job Overview

    Has subject matter expertise in one data stream or system. Provides expertise and guidance on operational activities and processes, ensuring IQVIA best practices are adhered to. Supports activities including the migration of processes between locations, undertakes optimization and efficiency projects and is consulted as a production subject matter expert during the implementation of new production systems and data services.

    Essential Functions

    • Developing professional expertise, applies company policies and procedures to resolve a variety of issues. Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. Exercises judgment within defined procedures and practices to determine appropriate action. Builds productive internal/external working relationships. May directly manage 1 or 2 employees
    • During the migration of processes
    • Preparation of migration plan.
    • Preparation of Knowledge Transfer needs and plans.
    • On site/Off site training if needed.
    • Link between local business and production hub.
    • Set and review migration KPI’s to ensure the project adheres to the agreed quality and timeliness
    • Overview the health of the process during the initial cycles and apply any amendment needed to the process.
    • During the implementation of new/upgraded production systems or data services.
    • Design and document the operational model with Local Office and development teams.
    • Provide input on the production processes that must be taken into account during development to fit with IQVIA best practices.
    • Involvement in assessing the production costs for the business case – including setup & ongoing costs, gathering costs across the hubs.
    • Play an integral role in the project team linking between LO, production and development teams.
    • Work with testing, development and production teams to prepare and run UAT.
    • Support the production teams during the rollout of the changes.
    • During the review of the operational activities:
    • Work with Business Unit and Production teams to identify areas for efficiency/productivity/quality gains
    • Perform end to end business review exercise (i.e Lean process).
    • Identify gaps on existing documentation and support on its completion.
    • Identification of potential cause for issues through the existing metrics or evidence (i.e. emails, complaints, etc).
    • Implementation of IQVIA best practices.

    Production Governance

    • Planning and implementation of ISO certification for production centres (Local Offices and Hubs)
    • Preparing and working with production centres to achieve process excellence during internal audits and ensuring plans are in place to maintain standards
    • Ownership of the production metrics including definition, capture and reporting. 
    • Working with production teams to implement best practice to capture metrics throughout the production processes.
    • Working with production and business unit senior management to define and report on Key Performance Indicators.

    Qualifications

    • Bachelor's Degree Preferred
    • Two (2) years experience with SQL Server and SSIS Req
    • Knowledge of business-wide organization and IQVIA systems and best practices.
    • Full technical knowledge of most phases of systems analysis.
    • Demonstrated ability to understand client requirements, systems and processes.
    • In-depth knowledge of current systems and business processes.
    • High communication skills.
    • Capability to work in multicultural team environment.

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    International Project Director - Emerging Markets

    JOB DESCRIPTION

    • IQVIA is delighted to be recruiting for an International Project Director, responsible for managing teams across Europe and beyond.

    Roles and Responsibility

    • Provide executive project management for complex multi-country multi-service commercial, medical and service improvement projects with duration of 1 – 5 years, headcount from 10 – 100, 2 – 10 country involvement and $5 – 50m service revenue value
    • Manage local project managers and administrators to ensure service excellence and adherence to project plan
    • Liaise closely with senior European-level customer contacts on a day-to-day basis to ensure project is aligned to customer objectives
    • Chair governance committee with participation by C-suite customer contacts and senior IQVIA executives
    • Provide proactive guidance to customers around ways to optimize their objectives
    • Align with local country operations and other International Project Directors to ensure the dissemination of best practice in project management

    Job Description

    • Manage staff and managers in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems.
    • Approve actions on human resources matters in consultation with Human Resources and other relevant departments.
    • Direct the hiring and selection process for Medical Sales staff by conducting candidate review through participation in the interviewing process. Establish methods to develop and evaluate office / region based on boarding processes.
    • Develop standard processes to ensure that staff has the proper materials, systems access and training to complete job responsibilities. Oversee the execution of the training plan and mentored training experiences for a region / office / country. Act as a coach and mentor for managers.
    • Work collaboratively with customers and other functional leadership to manage customer related challenges to achieve exemplary customer service. Provide an overall strategic focus for the customer by working in association with them to reach planned and agreed partnership policies that fully optimise the synergies of the relationship.
    • Drive account development, managing customer relationships and work with Business Development to strengthen relationships with existing clients and generate awareness on prospects.
    • Manage the financial performance of multiple varied projects, (e.g. achievement of financial targets, invoicing, cross charging, gap analysis, cost control, cash flow revenue and profitability), identify and manage financial issues and provide regular feedback on the financial performance of the team and project.
    • Define and implement required work patterns and call quality goals for team including coverage, frequency, pattern and chronology of brand marketing plan requirements on the target audience.
    • Ensure attainment of customer defined brand message delivery expectations, to ensure that the positioning of the brand in the market place is in line with marketing strategy.
    • Guide and direct the Analytics Department to build and create the required analytical tools.
    • Ensure the reporting of any identified Adverse Events in line with prevailing process and guidelines.
    • Project a professional impression of the Company and act in accordance with the relevant Pharmaceutical Industry’s Code of Practice

    Required Knowledge, Skills and Abilities

    • Strong knowledge of Bio-Pharmaceutical industry
    • Strong leadership qualities,
    • Strong presentation and influencing skills
    • Strong team player with high level of resilience
    • Strong collaborator and able to build networks across a complex business
    • Attention to detail and ability to work simultaneously on multiple priorities
    • Ability to influence others both internally and externally
    • Experienced in dealing with complex and day to day employment scenarios
    • Prior experience in managing delivery of patient support or market access projects
    • Ability to work creatively in a fast paced environment maintaining flexibility and changing priorities to meeting demanding timelines
    • Excellent customer service skills
    • Financial, analytical and problem solving skills with the ability to develop and articulate recommendations and solutions based on this analysis.
    • Strong organizational, planning, project management and logistics skills.
    • Strong software and computer skills, including MS Office applications.
    • Ability to establish and maintain effective working relationships with coworkers, managers and clients
    • Familiarity with relevant industry and legislative codes of conduct.

    Minimum Required Education and Experience

    • Bachelor’s Degree and at least 10 years relevant experience within the pharmaceutical industry or agency environment with management experience; or an equivalent combination of education, training and experience.

    Physical Requirements

    • Extensive use of keyboard requiring repetitive motion of fingers.
    • Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
    • Regular sitting for extended periods of time.
    • Regular travel is required

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    16351-Dir, Culture and Learning

    BASIC FUNCTION:

    • Manages, oversees, and supervises the IQVIA Biotech Learning Development Department.
    • Implements organizational efforts across employees in all geographies, which are aligned to and advance the IQB People Strategy and Culture.
    • Applies expertise to identify, organize and establish effective initiatives that drive organizational optimization and people / process improvements that increase value-add throughout the organization and supporting the success of IQVIA Biotech.

    ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

    • Plans, schedules, directs, controls, monitors, organizes, secures, and manages resources to bring about the successful completion of IQB programs and/or projects.
    • Champions organizational culture in alignment with the IQB Culture Anchors and core values
    • Develops the IQB culture road map based on business needs
    • Build relationships and liaise with staff at all levels of the organization.  Actively listen for culture and organizational gaps between employee/manager/executives and ensure employee experience and behavior are aligned with the IQB People Strategy and Cultural Anchors.  Create, propose and implement strategies to address these gaps as needed.
    • Provide consultation to executive leaders on organizational culture and lead and/or assist with designated culture initiatives. Participate in strategic meetings and focus teams serving as advisor while gathering potential initiative insight for future engagement.
    • In conjunction with senior/executive management will determine initiative structure providing leadership regarding the scope and types of initiatives appropriate for team involvement.
    • Determine initiative scope, timelines, and feasibility and ensure alignment with overall strategy ensuring alignment and incorporation with overall IQVIA strategy.
    • Champion learning and development within the organization
    • Support organizational team development
    • Plan, organize and oversee the Learning and Development functions: Select and hire departmental staff, within budgetary constraints and in accordance with company policy.
    • Perform other business activities and related duties as required and assigned

    KNOWLEDGE, SKILLS AND ABILITIES:

    • Excellent verbal and written communication skills with all levels of staff, including executive management, and with clients
    • Demonstrated ability to use high level of tact, diplomacy, and empathy/understanding in a global environment across multiple cultures
    • Demonstrated ability to use a high level of independent judgment and discretion when handling sensitive and confidential matters
    • Ability to develop strategy and deliver effective initiatives to advance the IQB People Strategy
    • Ability to build strong relationships and liaise across department/functional areas
    • Excellent planning and organizational skills
    • Excellent ability to perform multiple tasks effectively and efficiently with minimal supervision while meeting deadlines
    • Working knowledge of MS Word, Excel, PowerPoint

    CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:

    • Ability to travel domestically and internationally as needed
    • Very limited physical effort required to perform normal job duties

    MINIMUM RECRUITMENT STANDARDS:

    • BS/BA degree and a minimum of ten (10) years’ relevant experience, in the clinical research industry and/or culture and staff development roles.
    • At least 4 of those years include management experience. 
    • Demonstrated ability as a team player, working effectively at all levels of an organization.
    • Demonstrated high degree of independent judgement and discretion
    • Excellent interpersonal and organizational skills required.
    • Strong computer literacy and knowledge required.
    • Professional coaching experience and credentials preferred.
    • Experience conducting personal/staff development training programs.
    • Knowledge of culture and change management frameworks and models.
    • Knowledge of clinical research, with a global understanding of the general working processes of clinical research organizations is preferred.

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    Proposal Development Manager

    Job Overview
    Individual contributor with advanced knowledge acquired from several years of experience in the professional discipline. Works independently under limited supervision.

    Essential Functions

    • Acts as a Regulatory Team Leader on complex projects, which may include technical writing and/or may act as a Project Manager for a stand-alone project, with guidance from senior staff as appropriate;
    • Competently writes regulatory and/or technical documents with minimal review by senior staff;
    • Establishes relationships with many customers; may meet face to face without rest of team to discuss regulatory issues and present lessons learned. Adopts a proactive and flexible approach to resolve any issues;
    • Undertakes detailed review and management of budgets related to projects, including out of scope activities. Ensures revenue is recognised and challenges when appropriate, may seek guidance from senior staff as appropriate;
    • May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development;
    • May present to clients at bid defense meetings by phone or in person, for a range of regulatory deliverables, at discretion of senior staff;
    • May write new regulatory standard operating procedures, and/or propose revisions and/or act as reviewer for regulatory standard operating procedures, as assigned and appropriate.
    • May be involved in a Regulatory and/or IQVIA Initiative;
    • Performs other tasks or assignments, as delegated by Regulatory management;
    • May manage meetings with Regulatory Agencies;
    • May be assigned as Reviewer and/or Approver for Regulatory standard operating porcedures or cross-functional standard operating porcedures owned by other operations;
    • May support global regulatory or technical initiatives or act as a regional representative on a cross-functional initiative;
    • Performs other duties, as business needs require;

    Qualifications

    • Bachelor's Degree Degree in Lifescience or related discipline Req Or
    • Master's Degree Degree in Lifescience or related discipline
    • At least 8 years relevant experience
    • Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines, as appropriate;
    • Possesses a specific regulatory or technical expertise. Sufficient knowledge of managing regulatory projects, project deliverables on a time bound manner;
    • Expert in planning and delivering work on time keeping quality parameter in mind;
    • Knowledge of regulatory procedures in appropriate region – particularly marketing authorization transfers and relevant cross-functional dependencies;
    • Good working knowledge of regional regulatory intelligence;
    • Ability to work closely with client regional heads to determine the MAT, Regulatory Publishing & submission strategy and execute marketing authorization transfer plan, if applicable;
    • Good understanding of pharmacovigilance activities relevant to transfer of marketing authorization;
    • Ability to establish and maintain effective working relationships with coworkers, managers and clients;
    • Strong software and computer skills, including Microsoft Office, publishing applications and tools, as applicable;
    • Ability to work on several projects, with direction from senior staff as appropriate;
    • Ability to follow standard operating porcedures consistently; provides independent thought to assist in process improvements;
    • Ability to make decisions on discrete tasks under senior supervision;
    • Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education;
    • Experience of involvement in regulatory strategy and determination of documentation requirements, timelines, budgets for MATs, Publishing projects;
    • Project leadership experience;
    • Makes adjustments or recommended enhancements in systems and processes to solve problems or improve effectiveness of job area;
    • Problems faced are general and may require understanding of broader set of issues, but typically are not complex;
    • Ability to adapt quickly to a rapidly changing environment;
    •  Applicable certifications and licenses as required by country, state, and/or other regulatory bodies

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    Health Technology Assessment Consultant

    JOB DESCRIPTION
    Main responsibilities:

    • Identification of relevant publications by HTA agencies in multiple countries/regions (“scouting”)
    • Data entry of around 300 data points that need to be identified, selected, and processed from the HTA reports
    • Quality control of entered data
    • Writing a newsletter reporting on HTA and reimbursement policy developments
    • Participation in client project deliverables on diverse research questions and therapy areas
    • Provide insight into the HTA, and pricing & reimbursement processes and policies of countries (requires continuous development gaining knowledge of these systems and staying up to date)

    Minimum qualifications/experience:     

    • Bachelor/Honours/Masters in sciences (e.g. pharma, biochemistry, chemistry, biotechnology, especially anything with a clinical background), health economics, public health, healthcare management; or equivalent (PhD not required and likely to be overqualified)
    • 2 – 4 years’ experience, preferably in HTA, CRO, HEOR, pharma or related industry

    Ideal candidate:

    • Conscientious, very detail-oriented, strong language skills (especially written English), knowledge of HTA and/or health economics, knowledge of pharma industry; self-starter and ability to work independently; strong communication skills; ability to work under pressure

    Top 3 criteria for success in this role:

    • Ability to provide high quality work under time pressure
    • Ability to identify and relay accurate and relevant information
    • Clear communication

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    Sr Business Intelligence Analyst

    Job Overview
    Viewed as the subject matter expert (Qlik Sense and/or Qlikview) with specialization and ownership in one data asset and/or breadth of knowledge across multiple assets. Provides expertise and guidance on operational activities and processes, ensuring IQVIA best practices are adhered to.  Supports activities including the migration of processes between locations, undertakes optimization and efficiency projects and is consulted as a production subject matter expert during the implementation of new production systems and data services.

    Essential Functions

    • Hands on experience in Qlik Sense development, dashboarding and data modeling and reporting (ad hoc report generation) techniques.
    • An experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways. Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in own area of expertise. 
    • Leadership qualities and thoughtful implementation of Qlik Sense best practices in order to deliver effective Qlik Sense solutions to the users.
    • Able to comprehend and translate complex and advanced functional, technical and business requirements into executable architectural designs.
    • Creating and maintaining technical documentation.
    • Experienced in data integration through extracting, transforming and loading (ETL) data from various sources.
    • Strong communication skills (verbal/written) to deliver the technical insights and interpret the data reports to the clients. Also helps in understanding and serving to the client’s requirements.
    • Preparation of Knowledge Transfer needs and plans.
    • On site/Off site training if needed.
    • During the implementation of new/upgraded production systems or data services.
    • Design and document the operational model with Local Office and development teams.
    • Provide input on the production processes that must be taken into account during development to fit with IQVIA best practices.
    • Involvement in assessing the production costs for the business case – including setup & ongoing costs, gathering costs across the hubs.
    • Play an integral role in the project team linking between LO, production and development teams.
    • Work with testing, development and production teams to prepare and run UAT.
    • Support the production teams during the rollout of the changes.
    • During the review of the operational activities:
    • Work with Business Unit and Production teams to identify areas for efficiency/productivity/quality gains
    • Perform end to end business review exercise (i.e. Lean process).
    • Identify gaps on existing documentation and support on its completion.
    • Identification of potential cause for issues through the existing metrics or evidence (i.e. emails, complaints, etc.).
    • Implementation of IQVIA best practices.
    • Production Governance
    • Preparing and working with production centers to achieve process excellence during internal audits and ensuring plans are in place to maintain standards
    • Ownership of the production metrics including definition, capture and reporting. 
    • Working with production teams to implement best practice to capture metrics throughout the production processes.
    • Working with production and business unit senior management to define and report on Key Performance Indicators.

    General

    • Provides direct support to client facing teams or 3rd parties.
    • Leads project teams to perform ongoing analysis and evaluation of existing processes with the objective of providing continuous improvements.

    Work Experience

    • Three plus (3+) years advanced Qlik Sense experience or Four plus (4+) advanced Qlikview
    • Strong experience within Qlik (Qlik Sense, NPrinting, QlikView) incl. SQL capabilities - both front-end and QMC knowledge essential. 
    • Proven experience with various data sources and building/managing Data Warehouse and ETL processes
    • Must be good at Data transformation, the creation of QVD files and set analysis
    • Solid knowledge and understanding of data infrastructure and various data sources
    • A strong analytical and logical mindset is much appreciated.
    • Well-versed with concepts and techniques of Business Intelligence and Data Warehousing.
    • Must be familiar with a project’s complete life cycle implementation of at least 1 to 2 projects.
    • Skilled in Qlik Sense web integration, advanced SQL knowledge, Stored Procs, SQL scripting, nested selection, stored procedures, triggers, analytic functions, tuning etc.
    • High communication skills.
    • Capability to work in multicultural team environment.
    • Demonstrated ability to understand client requirements, systems and processes.

    Qualifications

    • Qlik Sense or Qlikview Certification advantageous

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    Project Management Analyst

    JOB DESCRIPTION

    Project Management Analysts (PMA) are an integral part of clinical trial delivery, liaising with clinical teams to improve patients’ lives by bringing new drugs to the market faster. The PMA works in partnership with the Project Leader (PL)/Clinical Project Manager (CPM) providing support with project management activities to mitigate risk, control cost, manage project schedule, and ensure customer satisfaction related to assigned project/s.

    Essential Functions

    • Establish and manage performance dashboards, analyze event triggers/alerts and determine appropriate follow up for Project Leader (PL) or other function(s) to act upon.
    • Coordinate project schedule and ensure timely updates of all key milestone and partner with PL on related calls.
    • Coordinate and support the risk and issue management process.
    • Manage all aspects of the Project Finances including Estimate at Completion (EAC), monthly expenses, invoices and reconciliation.
    • Demonstrate compliance with the Vendor and Purchase Order (PO) Management process.
    • Implement and maintain baseline and change control processes.
    • Ensure PL has timely and accurate data on areas including cost, schedule, scope, utilization, change orders and quality to support better decision-making.
    • Develop and maintain relevant sections of Project Management Plans.
    • Review and support project resource allocation within project budgeted for assigned portfolio/ projects.
    • Prepare correspondence, including meeting minutes, for project team and/or customer.
    • Organize and partner with PL in managing internal project team and customer meetings.
    • Prepare project status reports and presentation materials for internal project team and customer meetings.
    • Manage and coordinate core file reviews and support audits as needed. Drive e Trial Master File (eTMF) filing compliance focusing on completeness, timeliness and quality.
    • Manage project specific eTraining and oversee compliance.
    • Coordinate and support onboarding of new Key Project Team Members and system access.
    • Monitor project metrics and make required updates in IQVIA systems to ensure accurate and timely reporting is available to senior management.
    • Participate in regional initiatives to support Project Management Analyst (PMA) community and aid personal development.

    Qualifications

    • Bachelor's Degree Life sciences or other related field Req
    • Typically requires 0 - 2 years of prior relevant experience.
    • Requires knowledge of principles, theories, and concepts of a job area, typically obtained through advanced education.
    • 1 year of relevant clinical research experience with analytical/financial skills or relevant Project Management experience or equivalent combination of education, training, and experience.
    • Knowledge of clinical trials - knowledge of clinical trial conduct and skill in applying applicable clinical research regulatory requirements i.e. International Conference on Harmonization (ICH), Good Clinical Practice (GCP), relevant local laws, regulations, and guidelines, towards clinical trial conduct.
    • Communication - strong written and verbal communication skills including good command of English language.
    • Problem solving - problem solving skills.
    • Organisation - planning, time management and prioritization skills.
    • Prioritisation - ability to handle conflicting priorities.
    • Quality - attention to detail and accuracy in work.
    • Results-oriented approach to work delivery and output.
    • IT skills - good software and computer skills, including Microsfot Office applications, including but not limited to, Microsoft Word, Excel, and PowerPoint.
    • Collaboration - ability to establish and maintain effective working relationships with coworkers, managers and clients.
    • Cross-collaboration - ability to work across geographies displaying high awareness and understanding of cultural differences.
    • Effective communication - ability to influence without authority.
    • IQVIA Core Competencies - ability to demonstrate all IQVIA competencies (Client Focus, Collaboration, Communication, innovation, Ownership).

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    Senior CRA - Oncology A

    Job Overview
    Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

    Essential Functions

    • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
    • Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
    • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
    • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
    • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
    • Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
    • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
    • Collaborate and liaise with study team members for project execution support as appropriate.
    • If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
    • If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

    Qualifications

    • Bachelor's Degree in scientific discipline or health care preferred.
    • Requires at least 2 years of site monitoring experience part of which must involve oncology monitoring.
    • Equivalent combination of education, training and experience may be accepted in lieu of degree.
    • Good knowledge of, and skill in applying, applicable clinical research regulatory requirements.
    • i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
    • Good therapeutic and protocol knowledge as provided in company training.
    • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
    • Written and verbal communication skills including good command of English language.
    • Organizational and problem-solving skills.
    • Effective time and financial management skills.
    • Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

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    Principal Statistical Programmer: Real World Evidence – homebased or hybrid working

    Job Overview:

    • As a Principal Statistical Programmer/Programming Scientist, you will provide advanced technical expertise to develop process methodology for the department to meet internal and external clients’ needs, across complex projects and studies.
    • This involves planning and coordinating the development of integrated programming solutions serving the full spectrum of statistical programming needs.
    • You will provide internal consulting services, including specifications and user needs analysis for complex project or client requirements.

    Requirements:

    • 7+ years’ Statistical Programming experience within the Life-Science Industry
    • Advanced knowledge of statistics, programming and/or clinical drug development process
    • Advanced knowledge of computing applications such as Base SAS, SAS Graph and SAS Macro language
    • Advanced knowledge of relevant Data Standards (such as CDISC/ADaM/SDTM)
    • Bachelors or Masters’ in Computer Science, Mathematics or equivalent
    • Already possess the right to work in EMEA

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    Senior Statistical Programmer: Real World Evidence - homebased or hybrid working

    Job Overview:

    • As a Senior Statistical Programmer, you will provide experienced technical expertise to develop process methodology for the department to meet internal and external clients’ needs.
    • You will plan and coordinate the development of integrated programming solutions, serving the full spectrum of statistical programming needs, along with providing technical expertise and leadership to the department and provide internal consulting services, including specifications and user needs analysis for complex project or client requirements.
    • Acting as a lead on studies, you will directly communicate with internal and client statisticians and clinical team members to ensure appropriate understanding of requirements and project timelines and support the training of new or junior team members. As well as estimating programming scope of work, manage resource assignments, communicate project status and negotiate/re-negotiate project timelines for deliverables.

    Please apply in English

    Essential Requirements:

    • 5+ years Statistical Programming experience within the Life-Science industry
    • Experience in SAS® Base, and good knowledge of SAS® graph and SAS® Macros
    • Ability to implement more advanced statistical procedures as per specifications provided by Biostatisticians.
    • Excellent knowledge of CDISC standards (SDTM and ADaM)
    • Already possess the right to work in EMEA
    • Thorough understanding of relational database components and theory
    • Excellent application development skills
    • Experience as technical team lead, directly engaging clients and coordinating tasks within a programming team
    • Bachelors or Masters’ in Computer Science, Mathematics or equivalent
    • In-depth knowledge of applicable clinical research regulatory requirements, i.e. Good Clinical Practice
    • (GCP) and International Conference on Harmonization (ICH) guidelines

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    Senior Clinical Data Specialist/Associate Lead Data Manager (Home or Office based) - IQVIA Biotech

    BASIC FUNCTIONS:

    • Senior Clinical Data Specialist position is to ensure a quality database per industry standards and client specifications, while being a leader within the department as a subject matter expert for a system and/or process.

    ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

    • Clinical Data and Query Review:
    • Create listings using ad hoc query tools
    • Issue queries and review query responses with the highest level of quality based upon the Data Review Plan, Manual Review (Tumor Response, AE/CM compares), and Reconciliation (Laboratory, SAE, ECG, and other vendors)
    • Assist other data reviews for Biostatistics, Medical Review, Client, and other ad hoc reports

    Oversees System Development:

    • Create or draft CRF design, edit check specification and DM listings
    • Consolidate comments from internal/sponsor for discussion and approval
    • Ensure all non-DM activities related to database development are completed in a timely manner
    • Subject matter expert for DM product or process:
    • Create and Update SOPs/WP related to the product or process
    • Provide training for DM and other staff members on process and/or product implementation
    • Consult with DM leads or other team members on implementation and best practices
    • Participate in user group meetings as the IQVIA Biotech representative

    Study Management:

    • May serve as Lead DM or Back-up DM lead
    • Produce and Review Metric reports for internal/external project team
    • Provide feedback to improve the system or reports
    • Discuss roadblocks for getting processes done in a timely manner
    • Review project budgets and staffing projections for data management activities
    • Provide the DM lead or PM with status updates on tasks that are assigned
    • Assist with the on the job training of DM staff for the study

    KNOWLEDGE, SKILLS AND ABILITIES:

    • Team player with ability to work well with technical and clinical team members
    • Ability to collaborate with entire clinical team (CRAs, Safety, Bios, etc.)
    • Excellent knowledge of clinical data concepts including knowledge of unique data collection concepts (RECIST, CDISC/CDASH, Labs, Adjudication, etc.)
    • Ability to adhere to and create detailed DM study instructions and documents (CRF guidelines, Trial Design Document, edit check specifications, etc.)
    • Ability to perform research for data collection and protocol specific topics
    • Proficiency with multiple DBMS processing systems (preferred systems are InForm and Rave)
    • Organized and thorough with attention to details
    • Effective Interpersonal skills and excellent communications skills, verbal, written and listening
    • Ability to learn new things, teach others, and accept constructive criticism
    • Effective logical thinking ability regarding Problem-solving skills
    • Proficiency in computer applications (Windows, Excel, Word, Outlook etc.)
    • Ability to work independently

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    Senior Biostatistician (m/w/d)

    JOB DESCRIPTION
    IQVIA Data Science Staffing Solutions (DSSS) department is looking for new statisticians to join our fast growing teams. We work with big pharmaceutical companies and in this role you would become a part of a client's team. You would be working in a cross functional environment with people located in different countries around the world. A perfect role for people seeking a high profile role.

    ABOUT THE ROLE

    • Provides statistical methodology and project management support in the delivery of standard and custom studies.
    • Applies appropriate methodology when implementing studies.
    • Defines statistical design and methodology to meet client information needs, conducts statistical analyses to derive conclusions from the study, and identifies new opportunities for standard reports and for value-added analytics.
    • Implements tactical study plans in answer to business questions, performs quantitative research, and provides written summaries of study results.
    • Participates in selecting statistical methodology for use in the development and launch of new products.
    • Gathers recommendations from others to develop research plans, identifying appropriate data sources and delivery options in meeting client information and analyses needs.
    • May consult with clients in support of project delivery.
    • Works on projects where independent judgment is used within generally defined procedures and practices.

    RESPONSIBILITIES

    • Coordinate the development of analysis plans, table shells, programming and table specifications, the production of tables, listings and figures, data review and statistical analysis. 
    • Perform protocol development, sample size calculation, protocol and CRF review. 
    • Advise data management staff on database design, and critical data. May advise on validation checks. 
    • Write statistical sections of integrated reports. 
    • Provide expert statistical input into and review of statistical deliverables (i.e. analysis plans, table shells, programming and table specifications, data review, tables, listings, figures and statistical sections for integrated reports) and data management deliverables (i.e. database design, validation checks and critical data). 
    • Act as statistical team lead for single complex studies or groups of studies. 
    • Understand the Scope of Work, budget and quote assumptions, estimate the work completed, manage scope, and provide revenue and resource forecasts for single studies. May manage project budget and resource requirements. 
    • Perform the review of RFPs and QIPs, prepare proposal text and attend bid defense meetings. 
    • Manage customer relationships. 
    • Provide training and guidance to lower level and new staff. 

    REQUIRED SKILLS AND ABILITIES

    • Excellent written and oral communication skills including grammatical/technical writing skills
    • Excellent attention and accuracy with details
    • In-depth knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines Familiarity with moderately complex statistical methods that apply to applicable clinical trials
    • Strong individual initiative
    • Strong organizing skills
    • Strong working knowledge of SAS computing package
    • Familiarity with other relevant statistical computing packages such as nQuery
    • Strong commitment to quality
    • Ability to effectively manage multiple tasks and projects
    • Ability to provide and accept direction of lead team members
    • Ability to solve moderately complex problems
    • Ability to establish and maintain effective working relationships with coworkers, managers and clients
    • Working knowledge of relevant Data Standards (such as CDISC/ADaM)

    MINIMUM REQUIRED EDUCATION AND EXPERIENCE

    • PhD/Master's/ /Bachelor's degree in Biostatistics or related field
    • Minimum 3 years relevant experience; or equivalent combination of education, training and experience
    • Requires intermediate level knowledge of principles, theories, and concepts of a job area, typically obtained through advanced education combined with experience.

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    Senior Statistical Programmer - Remote opportunities

    JOB DESCRIPTION
    IQVIA is looking to appoint statistical programmers to utilize the SAS programming language to develop clinical study report materials according to the objectives of a clinical trial for regulatory submissions. Programming and performing related tasks serving the full spectrum of statistical programming needs in our DS3 environment (home or office based):

    Responsibilities:

    • Import data from various sources
    • Program quality control checks for source data and reporting data issues
    • Interpret project level requirements and develop programming specifications
    • Write programming code following established Good Programming Practices
    • Program SDTM and ADaM datasets
    • Program to create statistical analysis tables, listing and figures
    • Validate datasets and all statistical outputs per prescribed gate checks
    • Communicate with internal and client statisticians and clinical team members to ensure appropriate understanding of requirements and timelines
    • Use and promote the use of established standards, SOPs, and standard methodologies
    • Export data and clinical study report materials
    • Provide training and mentoring to team members and department staff
    • You can help us bring clinical trial statistical analysis into the next generation. Award winning and innovative, we will give you access to cutting-edge in-house technology, allowing you to work on global projects across therapeutic areas. Be challenged in a fast-paced team environment that is collaborative in performing biostatistical analyses and advanced statistical programming. Development opportunities and mentoring at all levels enable you to progress your long-term career in the direction you choose.

    THE PERSON

    • We know that meaningful results require not only the right approach, but also the right people. Candidates should possess a Master’s or Bachelor’s degree in Biostatistics, Statistics, Mathematics, or Computer Science, and have a strong educational or practical evidence in programming.

    Key required skills include:

    • 3+ experience in Statistical Programmer role from CRO
    • Excellent accuracy, attention to detail, problem solving, organizational as well as interpersonal communication.
    • In light of the above, candidates for the roles should exhibit the following skills and competencies:
    • Experience in programming in SAS within the CRO/Pharma/Biotech/Healthcare industries
    • Knowledge of statistics and exhibit routine and occasionally complex analytical skills
    • A focus on quality, accuracy, and completeness of work activities 
    • Excellent communication skills
    • A good understanding of Good Clinical Practice and ICH guidelines
    • Ability to independently lead (or have lead potential) and estimate programming scope of work, handle resource assignments, communicate work status, and work within project timelines for deliverables
    • Take initiative and can be counted on to get the job done, with integrity
    • Have the self-awareness to recognize when negotiating skills and assistance are needed
    • Ability to establish and maintain effective working relationships with co-workers, managers, and clients

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    Senior Data Team Lead

    PURPOSE

    Independently manage end-to-end delivery of data management services for single/multi-service projects, ensuring quality deliverables on time and within budget, to customer satisfaction. Provide comprehensive data management expertise to Clinical Data Management (CDM) team to provide high quality data management products that meet customer needs. Provide leadership and vision to the team in the areas of project planning, execution, and close-out; financial management; communications; and milestone deliverables. May perform role of Data Team Lead (DTL), Program Lead, Customer Site Manager, and/or a leadership role in a specific CDM task (e.g. Subject Matter Expert (SME). Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents.

    RESPONSIBILITIES
    Client Management:

    • Serve as primary point of contact for customer on data management deliverables; manage multiple large studies or program of studies (possibly global)
    • Provide leadership and senior support to DTLs on multiple large global studies/programme of global studies
    • Provide project management expertise working with customer data managers, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertise
    • Lead direct negotiations with customer, e.g., timelines, financial, process, resources
    • Maintain strong customer relationships
    • Ensure open communications with customer and Quintiles management to independently manage and meet contractual obligations

    Service Management:

    • Meet with Data Operations Coordinator (DOC) and/or Data Operations team members on a regular basis to ensure milestones meet timelines and quality deliverables; provide training and development on data management expertise to junior team members
    • Establish strong communications with Data Operations team, functional leads, project managers and all other stake holders
    • Independently manage DM service delivery with comprehensive DM process and technical expertise in executing projects
    • Serve as the escalation point for unresolved data issues; independently work with client data managers, vendors, internal team members for resolution
    • Ensure appropriate resources are assigned to meet project deliverables
    • Create and/or review and sign-off on all data management plan (DMP) documents;
    • Ensure service and quality meet agreed upon specifications per the DMP and contract/SOW
    • Implement proactive quality management plans across multiple projects/programmes/customer account. Manage service performance and provide leadership to identify root causes of issues and implement remedial actions
    • Continuously look for opportunities to improve service; develop and work with team to implement plan to re-organise and drive change (possibly across a customer account)
    • Ensure timely follow-up and resolution of compliance issues
    • Serve as Subject Matter Expert (SME) - Provide leadership and expertise in a specific CDM task or technology
    • Serve as customer site lead for one or more customers
    • Train and mentor junior DTL staff in DM expertise; may coordinate the work of more junior DTL staff
    • Independently maintain internal tracking databases and systems

    Financial Management/Business Development Support:

    • Ensure service and quality meet agreed upon timelines and deliverables in contract/Scope of Work (SOW)
    • Independently manage SOW/budget - Review financial reports on a monthly basis and participate in project reviews as requested - Identify out of scope tasks and track change orders to completion
    • Participate in pricing discussions across customer account
    • Serve as Project Manager for single service DM projects, including financial tracking, revenue recognition, and invoicing
    • Independently support RFP process (review RFP documents, pricing, attend bid defense)

    Other:

    • Independently bring process improvements and solutions to the CDM team/CDM department  
    • Lead a focus team or global or local best practice team  
    • Communicate lessons learned and/or present in CDM workshop(s)
    • Manage the development and implementation of new technology or tool
    • Present at professional conferences and/or publish articles in professional journals
    • Provide review and expert opinion in developing, revising, and maintaining core operating procedures and work instructions  
    • Perform other duties as directed by the functional manager

    REQUIRED EDUCATION KNOWLEDGE, SKILLS AND EXPERIENCE:

    • Bachelor’s Degree, or educational equivalent, in health, clinical, biological or mathematical sciences, or related field, and in-depth Data Management experience, which should include experience of having been CDM project lead;
    • Previous experience and proven competence in managing delivery of multiple global trials through full DM life-cycle (i.e. large trials of at least 1000 patients)
    • You must be eligible to live and work in the country you applying to without visa sponsorship
    • Demonstrated expert data management skills and advanced knowledge of the data management process (e.g., therapeutic area, extensive knowledge in DM processes, SAE reconciliation, external data vendor reconciliation, management of local laboratory data, and/or new technology)  
    • Previous experience and proven competence in handling complex customer negotiations and bid defence meetings independently
    • Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology  
    • Knowledge of operating procedures and work instructions and the ability to apply them in practice  
    • Knowledge of Good Clinical Practices and relevant regulatory guidelines  
    • Excellent communication, interpersonal, customer service, and teamwork skills  
    • Excellent organizational and problem-solving skills  
    • Excellent project management skills
    • Ability to work independently  
    • Comprehensive understanding of clinical drug development process  
    • Ability to establish and maintain effective working relationships with coworkers, managers and customers

    go to method of application »

    Principal Statistical Programmer (m/w/d)

    JOB DESCRIPTION
    IQVIA is looking to appoint statistical programmers at Principal level to utilize the SAS programming language to develop clinical study report materials according to the objectives of a clinical trial for regulatory submissions. Programming and performing related tasks serving the full spectrum of statistical programming needs in our DS3 environment (home or office based):

    Responsibilities:

    • Import data from various sources
    • Program quality control checks for source data and reporting data issues
    • Interpret project level requirements and develop programming specifications
    • Write programming code following established Good Programming Practices
    • Program SDTM and ADaM datasets
    • Program to create statistical analysis tables, listing and figures
    • Validate datasets and all statistical outputs per prescribed gate checks
    • Communicate with internal and client statisticians and clinical team members to ensure appropriate understanding of requirements and timelines
    • Use and promote the use of established standards, SOPs, and standard methodologies
    • Export data and clinical study report materials
    • Provide training and mentoring to team members and department staff
    • You can help us bring clinical trial statistical analysis into the next generation. Award winning and innovative, we will give you access to cutting-edge in-house technology, allowing you to work on global projects across therapeutic areas. Be challenged in a fast-paced team environment that is collaborative in performing biostatistical analyses and advanced statistical programming. Development opportunities and mentoring at all levels enable you to progress your long-term career in the direction you choose.
    • Lead studies.

    THE PERSON

    • We know that meaningful results require not only the right approach, but also the right people. Candidates should possess a Master’s or Bachelor’s degree in Biostatistics, Statistics, Mathematics, or Computer Science, and have a strong educational or practical evidence in programming.

    Key required skills include:

    • Excellent accuracy, attention to detail, problem solving, organizational as well as interpersonal communication.
    • In light of the above, candidates for the roles should exhibit the following skills and competencies:
    • Experience in programming in SAS within the CRO/Pharma/Biotech/Healthcare industries
    • Knowledge of statistics and exhibit routine and occasionally complex analytical skills
    • A focus on quality, accuracy, and completeness of work activities 
    • Excellent communication skills
    • A good understanding of Good Clinical Practice and ICH guidelines
    • Ability to independently lead (or have lead potential) and estimate programming scope of work, handle resource assignments, communicate work status, and work within project timelines for deliverables
    • Take initiative and can be counted on to get the job done, with integrity
    • Have the self-awareness to recognize when negotiating skills and assistance are needed
    • Ability to establish and maintain effective working relationships with co-workers, managers, and clients

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    Associate Director, Decentralized Trials

    JOB DESCRIPTION
    Manage and support the operational elements and execution of studies and/or programs to ensure delivery; time and quality resulting in strong financial performance and customer satisfaction and in accordance with SOPs; policies and practices from pre-award to close-out. Work with study(ies)/program(s) teams to focus on leveraging deep therapeutic expertise and IQVIA solutions to drive operational excellence and strategic leadership with our customers.

    Essential Functions

    • Participate in bid defense preparations. Lead bid defense presentations in partnership with Business Development for large sized, multiple and full service, multiple country and/or multi regional studies. Understand project strategy and operationalise the agreed upon approach.
    • Develop and/or support on the preparation of integrated study management plans in collaboration with the core project team.
    • Accountable for the strategic development and execution or delivery of clinical studies in line with agreed upon contracts while optimizing speed, quality and cost of delivery, ensuring consistent use of study tools and training materials and compliance with system updates, standard processes, policies and procedures.
    • Serve as primary project oversight and/or contact with customers and own relationship with the project’s key customer contact(s), communicate/collaborate with IQVIA business development representatives as necessary.;
    • Set objectives for the core project team according to agreed upon contract, strategy and approach, effectively communicate and assess performance, providing feedback and leadership.
    • Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles.
    • Monitor progress against contract and prepare/present project information proactively to all stakeholders internally and externally.
    • Supervise problem solving and resolution efforts to include management of risk, contingencies and issues. Take accountability for proactive contingency plans to mitigate risks.
    • Coach and/or mentor junior team members around project delivery, planning, project review, risk management and problem solving to ensure global alignment of work practices across the team.
    • Achieve project quality by identifyingand proactively managing quality risks and issues, responding to issues raised by project team members and planning/implementing appropriate corrective and preventative action plans.
    • May participate in executive committees as part of program leadership.
    • Ensure the financial success of the project including optimal management and assignment of resources to achieve project goals and profitability.
    • Forecast and identify opportunities to accelerate activities to bring milestones and revenue forward, implement appropriate actions to achieve.;
    • Identify changes in scope and manage change control process, including securing customer agreement to financial and milestone updates as necessary.
    • Identify and communicate lessons learned and best practices to promote continuous improvement.
    • Adopt corporate initiatives and changes, and serve as a change advocate when necessary.
    • Provide input to line managers on their project team members’ performance relative to project tasks. Support staff development. Mentor less experienced project team members on assigned projects to support their professional development.

    Qualifications

    • Requires advanced knowledge of job area, and broad knowledge of a other related job areas, typically obtained through advanced education combined with experience.
    • Requires 10 years clinical research experience including 6 years of project management experience or equivalent combination of education, training and experience.
    • Knowledge of clinical trials - Knowledge of clinical trial conduct and skill in applying applicable clinical research regulatory requirements i.e. ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct. Broad protocol knowledge, therapeutic

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    Global Site Activation Analyst, South Africa based

    JOB DESCRIPTION
    Global Site Activation Analyst (GSAA): Project Coordinator during Start-up & Maintenance Phase

    Global Site Activation - GSA

    • The GSA unit within IQVIA has the vision to be the clear market leader in clinical trial site activation driving best in class employee, site and customer experiences, and industry-leading outcomes and we look for passionate people to join our team.
    • The Global Site Activation Analyst is a Project Coordinator during Start-up & Maintenance Phase and plays an important role in the management and delivery of site selection, activation, maintenance and regulatory activities for selected studies or multi-protocol programs, working in close collaboration with the Global Site ID Lead, Site Activation Manager, Maintenance Lead and Country teams.
    • The Global Site Activation Analyst is responsible for study knowledge retention throughout the life-cycle of the study.
    • The GSAA is a fundamental role to support the delivery of our clinical trial portfolio and belongs to a global unit with vast career growth opportunities.

    Typical day to day includes working on 2 to 5 projects, duties to include:

    • System management and oversight
    • Customer reports
    • Workload Management
    • SA Planning support
    • Analytics & Performance metrics
    • EAC Support
    • CSA project team resourcing
    • Coordination for CSA tasks

    Required Knowledge, Skills and Abilities

    • Bachelor’s Degree in Life Science or related field and minimum 3 years of relevant experience in clinical, healthcare and/or Pharma companies
    • In-depth knowledge of clinical trial environment and Drug development process 
    • Good analytical skills
    • Strong communication and collaboration skills
    • Excellent Planning and troubleshooting skills 
    • Proven ability to establish and maintain effective working relationships with co-workers and managers across the globe
    • Demonstrable experience working on multiple projects/tasks balancing competing priorities
    • Expert with MS Excel and good knowledge of MS Office applications
    • Understanding of study financial management would be an advantage

    Method of Application

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