Associate Director, Clinical Data Management

Relay Therapeutics • Cambridge, MA

23h

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 to execute studies and support the translation of 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, deliverables, and outsourced work performed by CROs and vendors. It leads database development and eCRF design, validation, data cleaning, and database lock activities, while collaborating with cross-functional teams to ensure timely, high-quality deliverables and compliance with regulatory and quality standards. The Associate Director also contributes to data standards, system development, departmental processes, and training junior data managers.

Requirements

• Ideally, 7 or more years of pharmaceutical or biotechnology industry experience as a Data Manager.
• 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, excellent communication and public speaking skills, strong interpersonal and organizational skills, and close attention to detail.
• Ability to 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.
• Work directly with and oversee CROs and vendors conducting outsourced data management activities; manage CRO performance and data management metrics for assigned programs.
• Lead database development and eCRF design, user acceptance testing (UAT), 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 clinical trial data cleaning through database lock, including query generation and management, data review listings, reconciliation of serious adverse events, coding, and review of central and local laboratory and external data.
• Collaborate with cross-functional teams to ensure timely and high-quality data deliverables.
• Ensure compliance with global regulatory requirements and quality standards.
• Contribute to data standards, including CRF standards, and participate in data system development initiatives and database integration projects.
• Participate in SOP development, train junior data managers, and contribute to process mapping and other departmental activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed