Clinical Data Manager (Veeva EDC/ Clindex/ OC RDC)

Acts as the client's primary point of contact for data-related activities and processing, tracking, and managing clinical data and documentation. Additionally, they ensure that data is processed and tracked in alignment with regulatory and quality standards.

This role manages all data deliverables; liaises with project stakeholders such as project and data operations teams; and administers clinical documentation.

• Serve as Data Team Lead (DTL) on a program of 6-10 global clinical trials or 40+ increasingly complex central laboratory studies
• 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 or 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.
• Provide leadership and expertise in a specific CDM task or technology. Manage delivery of projects through full data management process life-cycle.
• 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.

Requirements:

• 5 years relevant experience including proven competence in managing delivery of multiple projects simultaneously through full data management study life cycle (large trials >1000 patients)
• Experience handling customer negotiations (e.g. bid defense meetings).
• Experienced and knowledge in the following EDC systems. Veeva EDC, Clindex, OC RDC or other similar
• Equivalent combination of education, training and experience.

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