Associate Director, Clinical Data Management
About The Position
The Associate Director, Clinical Data Management is accountable for the delivery, integrity, and quality of Relay’s clinical data across clinical studies. As an integrated member of the Clinical Data Management Team, this role provides in-house data management expertise for executing clinical studies and translating Relay’s science into medicines for patients. The position reports to the Executive Director, Clinical Data Management. The role oversees and executes data management activities for assigned studies, including timelines and key deliverables, and oversees CROs and vendors performing outsourced data management work. It leads database development, eCRF design, user acceptance testing, data import specifications, data collection and entry guidelines, validation specifications, and data cleaning through database lock. The Associate Director also collaborates with cross-functional teams, ensures regulatory and quality compliance, contributes to data standards and system initiatives, and supports departmental processes and junior staff training.
Requirements
- Ideally, 7 or more years of experience as a Data Manager in the pharmaceutical or biotechnology industry.
- Advanced experience with clinical data collection and cleaning across Phase I, II, and III studies.
- Strong, current knowledge of global regulatory and compliance requirements, including US CFR, EU CTD, ICH GCP, and CDISC.
- Experience overseeing CROs and vendors.
- Ability to work independently and flourish in a fast-paced small-company environment.
- Creative problem-solving ability and excellent communication and public speaking skills.
- Strong interpersonal and organizational skills and close attention to detail.
- Ability to pragmatically manage multiple projects and needs effectively.
Nice To Haves
- Sponsor experience is strongly preferred.
- Oncology experience and expertise in oncology drug development are preferred.
- Experience executing clinical studies across various phases is desirable.
Responsibilities
- Oversee and execute data management activities for assigned clinical studies, including timelines and key deliverables.
- Oversee CROs and vendors performing outsourced data management activities and manage CRO performance and data management metrics for assigned programs.
- Lead database development and eCRF design, user acceptance testing, data import specifications, Case Report Form completion guidelines, data entry guidelines, and related operations manuals.
- Lead data validation specifications and programs, including manual data review guidelines, computerized edit check programs, and Data Management Plans.
- Execute or oversee data cleaning through database lock, including clinical trial queries, data review listings, serious adverse event reconciliation, coding, and review of central and local laboratory and external data.
- Collaborate with cross-functional Relay teams to ensure timely, high-quality data deliverables.
- Ensure compliance with global regulatory requirements and quality standards.
- Contribute to data standards, including CRFs, and participate in data system development initiatives and database integration projects.
- Participate in SOP development, train junior data managers, support process mapping, and contribute to other departmental activities.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
No Education Listed
