Associate Director, Clinical Data Management

Role Summary

Associate Director, Data Management at Relay Therapeutics, accountable for delivery, integrity, and quality of clinical data across studies. Act as an integrated member of the Relay Tx scientific team, providing in-house data management expertise for the execution of clinical studies that translate Relay’s science into medicines for patients. Reports to the Senior Director, Clinical Data Management.

Responsibilities

• Oversee and execute data management activities for assigned clinical programs, including data timelines and key deliverables.
• Work directly with and oversee CROs and vendors for outsourced Data Management activities; responsible for CRO performance and data management metrics for assigned programs.
• Lead database development and eCRF design, UAT, data import specifications, Case Report Form completion guidelines, data entry guidelines, and related operations manuals.
• Lead data validation specifications and programs to assure data accuracy, e.g., manual data review guidelines, computerized edit check programs, Data Management Plans (DMP).
• Execute or oversee data cleaning through to database lock: generating/managing clinical trial data queries, data review listings, coding specified data (e.g., adverse events, concomitant medications), reconciling SAEs and central labs.
• Collaborate with a cross-functional team to ensure timeliness and quality of data deliverables; ensure compliance with global regulatory requirements and quality standards.
• Contribute to data standards including CRF and participate in data system development initiatives and database integration projects.
• Participate in SOP development, training of junior data managers, process mapping, and other departmental activities.

Qualifications

• 7+ years of experience in the pharmaceutical/biotechnology industry as a Data Manager; sponsor experience strongly preferred.
• Advanced experience with data collection and cleaning across Phase I–III studies; oncology experience preferred.
• Experience executing clinical studies across various phases; oncology drug development experience preferred.
• Strong and current knowledge of global regulatory and compliance requirements including US CFR, EU CTD, ICH GCP, and CDISC.
• Experience in CRO and vendor oversight.
• Motivated self-starter able to thrive in a fast-paced small company environment.
• Creative problem-solver with excellent communication and public speaking skills.
• Strong interpersonal and organizational skills with high attention to detail; pragmatic and able to manage multiple projects effectively.