Current Vacancies at IQVIA

Key Responsibilities:

• Production of High-Quality Deliverables: Completes and reviews more complex assigned tasks with a focus on accuracy. Conducts all appropriate validation requirements, according to SOPs, for each task undertaken. Checks programming logs for cleanliness and correct processing of data. Inputs into Data Issues log and follows issues to appropriate resolution

Datasets:

• Writes and maintains programming specifications datasets. Programs assigned datasets to industry standards. Handles dataset derivations and assignment
• Tables, Listings and Figures (TLFs):
• Programs TLFs, maximizes programming efficiency with use of biostatistical tools. Checks resulting output for format and content, and questions specification as needed. 

Leadership: 

• Perform as lead programmer on assigned studies. Through this, works closely with the Biostatistical Team Lead and Supervisor, to deliver on time, with high quality and within budget. Tasks include but are not limited to: 
• Develops an efficient programming strategy utilizing available tools and creation/ maintenance of project specific macros, ensures compliance with Good Programming Practice as per SOPs.
• Demonstrates and promotes efficient communication. If in lead role, runs meetings, documenting where necessary and following up on actions. 
• Actively participates in internal project team meetings, providestimely progress updates. 
• As a lead, will have input on estimate at completion (EAC) reporting

Timelines:

• Plans and documents timelines and forecasts resource needs

Project Programming Set Up: 

• Programming project set up and maintenance of BIOSETUP, global tools & project macros
• Programming project set up for integrated databases, with supervision

Statistical Analysis Plan (SAP) and Shells: 

• Performs programming review of SAP and shells, where applicable. Writes programming specifications/shells for safety outputs

Financials: 

• Shares accountability (with resource managers) of the financial success of their studies
• Responsible for sharing budget expectations with their team. 
• Understands 'scope of work' and has an awareness of contract and budget assumptions

Knowledge Sharing:

• Helps train staff regarding operational items and mentor’s junior staff

Risk Management: 

• Proposes solutions to mitigate risks.
• Other CDISC requirements: Reviews Pinnacle 21 output and resolves issues. Creates or performs quality control (QC) review of define.xmls, SDTM and/ or ADaM reviewers guide (SDRG, ADRG), under supervision as needed.;
• Perform lead programmer role on studies

Proposals:

• Review and comment on proposals/budgets at a study level
• present at bid defence meetings 

Customer: 

• Serve as primary point of contact for customer and consult on operational topics with clients.

Requirements: 

• Bachelors or Masters’ in Computer Science, Mathematics or equivalent
• 3+ years, statistical programming experience within the Life Science industry 
• Experience as project lead, directly engaging clients and coordinating tasks within a programming team
• Knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Knowledge of Base SAS, SAS/STAT, SAS Graph and SAS Macro Language
• Ability to independently lead multiple tasks and projects

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JOB DESCRIPTION

IQVIA’s Country Site Activation team are a global network who identify and activate sites to the highest quality to ensure patients on Clinical trials have access to safe and effective medication. We are leaders in innovation and first to new technologies meaning a vast amount of career development opportunities are available.

Our Senior Site Activation Specialists perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. You may also be involved in maintenance activities

You are expected to be a developing professional who works under moderate oversight and supervision and is responsible for making recommendations for enhancements in systems and processes to solve problems or improve effectiveness of job area.

• Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines
• Perform feasibility, site ID, start up and site activation activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members
• Prepare site documents, reviewing for completeness and accuracy
• Review, track and follow up the progress, the approval and execution of documents, questionnaires, CDA/SIF, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines
• Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information
• Review and provide feedback to management on site performance metrics.
• Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed
• Inform team members of completion of feasibility, site ID, regulatory and contractual documents for individual sites
• Provide local expertise to SAMs and project team during initial and on-going project timeline planning
• Perform quality control of documents provided by sites.
• May have direct contact with sponsors on specific initiatives

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• Bachelor’s Degree in Life Science or related field
• Minimum 3 years’ prior experience in life sciences or similar. Experience in a leadership capacity considered advantageous 
• Fluent/ native language capabilities in French and English
• Makes recommendations for enhancements in systems and processes to solve problems or improve effectiveness of job area
• Good negotiating and communication skills with ability to challenge
• Makes recommendations for enhancements in systems and processes to solve problems or improve effectiveness of job area
• Ability to handle change and ambiguity
• Ability to work on multiple projects
• Applicants will ideally have knowledge of applicable functional/regulatory requirements, including local regulations, SOPs and GCP/ICH

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Job Overview

Provide basic and some comprehensive data management expertise to the Clinical Data Management (CDM) 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 (DOC), Data Team Lead (DTL), or Functional Manager.

Essential Functions

• Serve as a Data Operations Coordinator (DOC) for one protocol with less then 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 DOC or DTL.
• 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."

Qualifications

• Bachelor's Degree Clinical, biological or mathematical sciences, or related field Req
• Equivalent combination of education, training and experience in lieu of degree.
• 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 coworkers, managers and clients. 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 coworkers, managers and clients.

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Our Senior Clinical Project Managers are an integral part of the Biotech project management team, responsible for project delivery of clinical studies to meet contractual requirements focusing on leveraging therapeutic expertise in Dermatology. Offering IQVIA Biotech’s suite of solutions to drive operational excellence and strategic leadership with our customers.

Responsibilities:

• Participate in bid defence presentations in partnership with Business Development and may lead the presentation for smaller, less complex regional studies.
• Develop integrated study management plans with the core project team.
• Accountable for the execution of clinical studies, or assigned portion of clinical studies, per contract while optimizing speed, quality and cost of delivery and ensuring consistent use of study tools and training materials and compliance with standard processes, policies and procedures.
• Set objectives of the core project team and/or sub-team(s) according to agreed upon contract, strategy and approach, effectively communicate and assess performance.
• 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 and/or sub-team information proactively to stakeholders internally and externally
• Manage risk (positive and negative) and contingencies proactively and lead problem solving and resolution efforts.
• Achieve project quality by identifying quality risks and issues, responding to issues raised by project team and/or sub-team members and planning/implementing appropriate corrective and preventative action plans.
• May serve as primary or backup project contact with customer and would then own the relationship with the project’s key customer contacts, as well as communicate/collaborate with IQVIA business development representatives, as necessary.;
• Build the cross-functional project team and lead their efforts; responsible for managing cross-collaboration of the core team and for overall project delivery to support milestone achievement and to manage study issues and obstacles.;
• Ensure the financial success of the project.
• Forecast and identify opportunities to accelerate activities to bring revenue forward.
• Identify changes in scope and manage change control process as necessary.
• Identify lessons learned and implement best practices.
• May be assigned as the primary contact for vendors leading project vendor management and vendor management related activities as per project requirements.

Qualifications and Experience Required:

• Bachelor's degree in life sciences or related field
• Global project management experience within the drug development industry, with previous CRO experience is ideal.
• Minimum 4 years prior project management experience and experience in clinical operations; or equivalent combination of education, training and experience
• In-depth therapeutic knowledge in one of our Dermatology therapeutic area

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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 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

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:

• Home Based/Remote
• 5+ 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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Purpose:

The Senior QA Auditor will plan and conduct independent audits to assess compliance with regulations, guidelines, and operating procedures.Prepare and distribute reports of findings to supervisor, operations staff, management, and customers. Provide consultation in interpretation of regulations, guidelines, policies, and procedures.Support management in promotion and assessment of compliance to regulations, guidelines and corporate policies.

Summary of Responsibilities:

• Plan, schedule, conduct, report and close audit activities in any of the countries involved with IQVIA contracts to assess compliance with applicable regulations/guidelines, customer requirements, IQVIA SOPs and project specific guidelines/instructions
• Evaluate audit findings and prepare and distribute reports to operations staff, management, and customers
• Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures
• Provide consultation to customers and monitors in interpretation of audit observations and formulation of corrective action plans
• Manage Quality Issues
• Present educational programs and provide guidance to operational staff on compliance procedures
• Review, approve investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA) and Effectiveness Check (EC) plans and track till closures for quality events arising from Quality Issues, Audits, Inspections or during similar QA activities
• Provide quality assurance consultancy activities and projects for clients within budget and established timelines
• Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements
• Host audits/inspections, Ensure proper conduct of customer-initiated audits and mock regulatory inspections, and assist in regulatory facility inspections
• May perform GLP Archivist duties where needed
• Manage/oversee quality events updates in eQMS and/or maintains the electronic quality management system (eQMS) and provides support in relation to the audit lifecycle
• Lead/collaborate/support in QA initiatives/projects for quality, process improvements
• Assist in training of new Quality Assurance staff

Required Education and Experience:

• Previous or current experience in a pharmaceutical, biotech, CRO, or other regulated area
• 5 years' experience in pharmaceutical, technical, or related area, of which 3 years in Quality Assurance. GXP experience.
• CAPA and GCP experience
• Life Sciencesce/Pharmaceutical degree

Required Knowledge, Skills and Abilities:

• Knowledge of word-processing, spreadsheet, and database applications..
• Extensive knowledge of pharmaceutical research and development processes and regulatory environments..
• Knowledge of quality assurance processes and procedures..
• Strong interpersonal skills..
• Excellent problem solving, risk analysis and negotiation skills..
• Strong training capabilities..
• Effective organization, communication, and team orientation skills..
• Ability to initiate assigned tasks and to work independently..
• Ability to manage multiple projects..
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.