Manager, Clinical Data Management

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Requirements:

• Bachelor's Degree in a Science-related or technical field or a similar area of focus and a minimum of 6 + years of experience within the biotech or pharmaceutical industry.
• Experience with the full Clinical Data Management activity life cycle (start-up, maintenance, and closeout).
• Established knowledge and experience working with Medidata Rave EDC.
• Knowledge of MedDRA and WHODrug coding, with experience overseeing coding and SAE reconciliation activities for clinical trials.
• Strong documentation and organizational skills, as well as a proven ability to be self-motivated and able to work independently.
• Excellent communication and presentation skills to efficiently relay information to project teams and other key stakeholders.

Responsibilities:

• Oversee and lead data management personnel at the CRO, ensuring the deliverables are aligned with business needs and timelines.
• Author, review, and revise related study plans, including Data Quality Management Plans, Data Validation Plans, Data Review Plans, eCRF Completion Guidelines, and other study documents to ensure quality and standardization.
• Represents Data Management on cross-functional project teams.
• Work closely with biostatisticians and other data scientists to analyze clinical data and generate statistical reports.
• Participating in the preparation of clinical study reports and other regulatory documents.
• Work with the clinical team to define study data review plan specifications.
• Prepare and provide data listings and reports as required (e.g. leadership reporting, DMCs, etc.).
• Provide review and guidance to protocol development as it relates to data collection and management.
• Lead the study team's activities regarding data management throughout the study lifecycle, from planning to start-up, conduct, and close-out.
• Accountable for creating and delivering Data Management documentation (i.e., eCRFs, CCGs, DMP, Data Transfer Specifications, etc.) and ensure documentation is appropriately filed within the Trial Management File (TMF).
• Lead or support the development of contracts with external vendors for data collection, cleaning, and reporting, and review the Scope of Work related to data management responsibilities.
• Partner with internal functional teams to manage and coordinate data collection and maintenance with external vendors to ensure deliverables and project milestones are being met.