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  • Posted: Jan 27, 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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    Senior Recruiter , Talent Acquisition

    Job Overview
    Support the continuous improvement of the staffing function through development and implementation for all staffing programs in an assigned business unit/department, primarily in one geography.   With guidance, conduct recruiting activity for management teams as assigned.

    Essential Functions

     

    •  Work with management in assigned service areas, business units or departments to source, select and hire qualified candidates to fill vacant positions using cost-effective techniques and in accordance with company policies, procedures and processes.
    •  Write job postings to post and advertise positions.
    •  Review applications and conduct interviews to obtain information regarding applicant's work history, education, training, job skills, and salary requirements.
    •  Create and coordinate job advertising in various media. Attend job fairs and develop and maintain contacts with colleges, universities, alumni groups, and other organizations to identify potential applicants.
    •  Work with external recruiters and employment agencies to identify and recruit candidates. Utilize Internet online recruiting sources to identify and recruit candidates.
    •  Meet with functional business leaders and executive management, as required, to discuss and establish staffing objectives and ensure they are achieved.
    •  Assist with training line management on recruiting, interviewing, and the selection process as required.
    •  Support a diverse workforce and comply with local and regional hiring guidelines and procedures, particularly for applicant tracking.
    •  Keep abreast of market trends and demands impacting the company’s ability to attract competitive candidates; coordinate with the compensation team on salary offer considerations and equity concerns.
    •  Ensure the provision of timely employee-related information to management teams as necessary.
    •  May be responsible for meeting established financial targets and assisting with business development activities depending on business line.

    Qualifications

    •  Bachelor's Degree  
    •  1 year experience within a staffing function as a recruiter or combination of recruiter and specialist experience Or
    •  Equivalent combination of education, training and experience
    •  Sound knowledge of legislation in the recruiting process
    •  Strong computer skills including Microsoft Office applications and HRIS applications
    •  Strong verbal and written communication skills
    •  Strong attention to detail
    •  Good problem-solving, judgment and decision-making skills
    •  Good understanding and awareness of  the commercial environment and market trends
    •  Good customer service skills
    •  Very high degree discretion and confidentiality
    •  Ability to multi-task, prioritize and plan routine activities
    •  Ability to establish and maintain effective working relationships with coworkers, managers and clients

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    Trial Data Manager

    JOB DESCRIPTION

    RESPONSIBILITIES  

    • Serve as point of contact and manage delivery of sponsor in-house projects within the FSP contract through full Data Management scope per agreed upon timelines, resource needs, best practices and with quality per FSP guidance and requirements.

    • Manage full life cycle of Data Management deliverables including CRF/e-CRF, database design and set-up, user acceptance testing (for trials in start-up and post-production changes for trials in conduct) and programming specifications, Data Management Plans, and database deliverables where applicable (excluding ALL project financial tasks).

    • Conduct comprehensive data management tasks including but not limited to data reconciliation, metric reporting, data review, writing and resolving data clarifications.

    • Establish strong communication with DM Support, Clinical Trial Lead (CTL), all core and extended CTT team members and functional leads as necessary to ensure all milestones/deliverables are met.

    • Manage process improvements and workload projections by provide LEAN/technical advice to solve problems and improve efficiency within the FSP and help others through the learning curve to achieve trial goals with subsequent implementation.

    • Provide comprehensive technical expertise to the DM Support, Programmer/Database Developer and Clinical Trail Team (CTT) and interact as need be.

    • Create and/or review and sign-off on all FSP data management plans and other relevant trial documents.

    • Serve as the escalation point for unresolved data issues working with CTL, DM support, vendors, and CTT as needed to ensure root cause identification, timely follow-up, and implementation of remedial actions/resolution of issues.

    • Escalate problems/issues to the attention of the PCDM/Engagement Manager and Data Analytics and Review Team (DART).

    • Comply with all IQVIA Corporate Policies, FSP specific Sponsor Standard Operating Procedures (SOPs)/Working Practices (WPs), FSP curriculum and key performance indicators.

    • Train, mentor and provide leadership to fellow FSP team associates on data management skills and processes.

    • Collaborate with TDM(s) to ensure DB start-up activities & Go-Live dates, deliverables and all milestones are met as per agreed upon timelines and per FSP standards.

    • As a LEAN practitioner and FSP ambassador identify and support initiatives and process improvement strategies that can assist project teams in achieving their goals and set FSP expectations.

    REQUIRED KNOWLEDGE, SKILLS AND ABILITIES    

    • 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) in Oncology studies
    • 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 defense meetings independently
    • Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology
    • Good working knowledge of Rave
    • 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 co-workers, managers and customers    

    MINIMUM REQUIRED EDUCATION AND EXPERIENCE

    • Bachelor’s Degree, or educational equivalent, in health, clinical, biological or mathematical sciences, or related field, and a minimum of 4 years direct Data Management experience at a Clinical Research Organization

    go to method of application »

    Snr Software Development Analyst

    Job Overview
    Provide experienced, comprehensive and advanced technical expertise as part of a team to develop and maintain clinical systems to meet internal and external client’s needs.  Plan and coordinate database design and development for local, regional, or transnational use.  Provide leadership to the Clinical System’s department in the area of technical expertise.

    Essential Functions

    •  Serve as Lead Programmer on the corporate team.
    •  Plan and coordinate database design, development, implementation, maintenance, and user support of clinical systems.
    •  Provide advanced technical expertise in conjunction with internal and external clients.
    •  Program, test, and document databases in accordance with programming standards and validation procedures.
    •  Program database manipulations and transfers of data for internal and external clients.
    •  Mentor other team members and Lead Programmers in training and developing technical and/or database expertise.
    •  Independently bring project solutions to the CDP teams and the Clinical Data Programming department.
    •  Collaborate with IT in evaluating and/or developing and implementing new technologies.
    •  Develop, revise, and maintain core operating procedures and working instructions with CDP management.
    •  Meet milestones as assigned, and interact with the project team to organize timelines, responsibilities and deliverables.
    •  Develop and maintain good communications and working relationships with teams and external clients.
    •  May interact with corporate team and CDM team members to negotiate timelines, responsibilities, and deliverables.

    Qualifications

    •  Bachelor's Degree Computer/life science or related field
    •  5 years of relevant work experience
    •  Equivalent combination of education, training and experience
    •  Clinical Data Programming:  Advanced knowledge of Oracle and/or SAS
    •  Laboratory Data Programming:  Advanced knowledge of VGL and/or BizTalk and/or C# and/or .NET
    •  Solid understanding of clinical drug development process
    •  Excellent organizational, communication, and technical database skills
    •  Ability to establish and maintain effective working relationships with coworkers, managers and clients

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    Senior Data Team Lead

    JOB OVERVIEW

    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 IQVIA 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-organize 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:

    • 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

    MINIMUM REQUIRED EDUCATION AND EXPERIENCE

    • Bachelor's Degree in health, clinical, biological or mathematical sciences, or related field

    • 5 - 7 years direct Data Management experience, including 5 or more years as a CDM project lead.

    • Equivalent combination of education, training and experience.

    SKILLS AND ABILITIES

    • 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).

    • 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 defense 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 co-workers, managers and customers.

    go to method of application »

    Manager, Clinical Data Management

    JOB DESCRIPTION

    RESPONSIBILITIES  

    • Manage a team of professional Data Management staff. Size of team could vary from 5+ upwards -15, depending on the Data Management Function.

    • Define and prioritize resource requirements and manage resource assignments across projects.

    • Directly responsible for utilization of staff.

    • Assess and document competency of staff to satisfy position responsibilities. Regularly set goals and evaluates and documents performance.

    • Propose salaries, promotion and termination actions.

    • Actively contribute to recruitment of new staff.

    • Implementation of department/office objectives.

    • Provide expert review and guidance for production of Data Management deliverables including CRF/e-CRF, database design and set-up, validation definition and programming, Data Management Plan and database deliverables to internal and external customers.

    • Provide technical advice and solutions with internal and external customers to solve problems and improve efficiency.

    • Participate in the development and implementation of new processes and technology.

    • Ensure that staff is trained and compliant with current operating procedures and work instructions and project scope of work.

    • Identify and address professional development/training needs of staff.

    • Mentor staff members to develop Data Management process, system, and drug development expertise.·Provide operational input into proposals and scope of work.

    • Participate in proposal defences.

    • Attend customer meetings and lead discussions of project requirements and strategic planning.

    • Understand scope of work, budget, and scope assumptions.

    • Identify out-of-scope work and provide revised costs with supporting documentation.

    • Ensure project milestones are met according to agreed upon timelines.

    • Actively manage quality throughout project.

    • May be Project Manager/Project Lead for a major study or a series/group of studies

    • Manage staff 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.

    REQUIRED KNOWLEDGE, SKILLS AND ABILITIES    

    • Advanced knowledge of Data Management processes and systems

    • Solid understanding of clinical drug development process

    • Excellent written and oral communication skills

    • Proven leadership skills

    • Excellent organizational skills and demonstrated ability to manage projects

    • Effective problem-solving skills

    • 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 nursing qualification with a minimum of 7 years of relevant work experience including people management; or equivalent combination of education, training and experience

    Method of Application

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