Associate Clinical Data Manager

Associate Clinical Data Manager
Empresa:

(Confidencial)


Associate Clinical Data Manager

Detalles de la oferta

Position: Associate Clinical Data Manager - Bloemfontein based

Job Description

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

RESPONSIBILITIES

Serve as Data Team Lead (DTL) on a program of 6-10 global clinical trials or 40+ increasingly complex central laboratory studies

Provide leadership to CDM team.

Manage CDM customer relationship for CDM project team to include leading (with minimal guidance) CDM customer negotiations on complex timeline, budgetary and other issues.

Provide marketing capabilities presentations and business development presentations.

Serve as Data Operations Coordinator (DOC) for one or three global clinical trials with fewer than 25 operations staff (excludes DE) or 20-40 central laboratory studies, or serve in a leadership role to a specific DM Task.

Serve as back-up for Data Operations Coordinator or Data Team Lead

Provide leadership to Operations team

Provide technical expertise

Serve as a Subject Matter Expert (SME)

Provide leadership and expertise in a specific CDM task or technology

Manage delivery of projects through full data management process life-cycle.

Management of Project timelines, Quality issues, Resource management and SOW (scope of work) / budget.

Provide justification for customer negotiations.

May serve as Project Manager for single service data management projects.

Manage comprehensive data management tasks pertaining to the documented project specifications.

Manage comprehensive quality control procedures.

Provide data management expertise and data management process improvement to CDM management.

Mentor other team members in training and developing data management expertise.

Independently bring project solutions to the CDM team and the CDM Department.

Manage a focus team or a best practice team

Manage the development and implementation of new technology/tool.

Present at professional conferences and/or publish articles in professional journals.

Provide CDM with technical expertise.

Provide review and expert opinion in developing, revising, and maintaining core operating procedures and working instructions.

Perform other duties as directed by the functional manager.

Meet objectives as assigned.

Develop and maintain good communications and working relationships with CDM and project teams.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

Thorough knowledge of the data management process and experience in specialized data management skills (e.g., therapeutic, extensive knowledge, SAE reconciliation, central laboratory, and/or new technology

Knowledge of operating procedures and work instructions and the ability to apply them in practice

Excellent experience and organizational, communication, and demonstrated expert data management skills

Comprehensive understanding of clinical drug development process (detail oriented)

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 5 years’ experience in clinical trials within a similar function, including proven competence in managing delivery of multiple projects simultaneously through full data management study life-cycle, including large trials > 1000 patients; and including experience in handling customer negotiations (e.g. bid defence meetings); or equivalent combination of education, training and experience

Requisitos

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