Job Description

SUMMARY OF POSITION:

Our biotech client is seeking a Senior Manager/Associate Director of Clinical Data Management to oversee clinical trial data in a dynamic and evolving environment. This role involves managing Data Management (DM) activities across multiple studies, including CRF design, database development, and data quality assurance. The position reports to the Director of Clinical Development and serves as the primary point of contact for data review.

RESPONSIBILITIES:

• Lead DM activities across multiple clinical trials.
• Represent CDM in cross-functional meetings.
• Ensure timely and high-quality DM deliverables, adhering to regulatory requirements.
• Manage vendor relationships and ensure effective vendor performance.
• Oversee the creation and maintenance of key CDM documentation (eCRF specifications, data validation plans, etc.).
• Conduct development testing of eCRFs and data integrations.
• Manage data transfers and review data consistency with transfer agreements.
• Participate in the RFP process and vendor evaluations.
• Review clinical study protocols, statistical analysis plans, and TFL outputs.
• Ensure DM documentation is inspection-ready.
• Lead initiatives to improve DM processes and data quality assurance.

QUALIFICATIONS:

• 6–8+ years of experience with a BS or equivalent degree (MS/MBA a plus).
• Experience with Phase I-IV clinical trials and CRO partnerships (rare disease experience is a plus).
• Proficiency in EDC, CDISC standards, SAS, and SQL.
• Strong understanding of clinical research regulations (FDA CFR, ICH GCP).
• In-depth experience with all aspects of Data Management, including CRF/database development, data quality, and vendor management.
• Proficiency with clinical data coding systems (MedDRA, WHO Drug).
• Strong interpersonal, organizational, and communication skills.
• Ability to identify project risks and propose solutions.
• Willingness to travel as needed.

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