Associate Director, Clinical Data Management

The role

You will be accountable for the delivery, integrity, and quality of clinical data across clinical studies. You will oversee CROs and vendors and lead database development and data cleaning activities.

What you will do

• Oversight and execution of data management activities for assigned clinical studies.
• Oversee CROs and vendors for outsourced Data Management activities.
• Lead database development and eCRF design, UAT, and data import specifications.
• Lead data validation specifications and programs.
• Execute or oversee data cleaning activities through to database lock.
• Collaborate with a cross-functional team to ensure data deliverables.
• Ensure compliance with global regulatory requirements and quality standards.
• Contribute to data standards and participate in data system development initiatives.
• Participate in SOP development, training of junior data managers, and process mapping.

Required qualifications

• 7+ years of experience in the pharmaceutical / biotechnology industry as a Data Manager.
• Advanced experience with data collection and cleaning covering Phase I, II and III studies.
• Strong and current knowledge in global regulatory and compliance requirements including US CFR, EU CTD, ICH GCP, and CDISC.
• Experience in CRO and vendor oversight.
• Motivated self-starter capable of working independently in a fast-paced small company environment.
• Creative problem-solver with excellent communication and public speaking skills.
• Strong interpersonal and organizational skills.
• High degree of attention to detail.
• Pragmatic and able to manage multiple projects and needs effectively.

Nice to have

• Sponsor experience is strongly preferred.
• Oncology experience is preferred.
• Experience in executing clinical studies across various phases is desirable.
• Expertise in oncology drug development is preferred.

About the company

Relay Therapeutics is a clinical-stage precision medicines company transforming the drug discovery process. They use a Dynamo platform to integrate experimental and computational approaches to drug protein targets.