Associate Director, Clinical Data Management

Relay Therapeutics • Cambridge, MA

5d • $146,000 - $208,000

About The Position

As Associate Director, Data Management, you will be accountable for the delivery, integrity, and quality of Relay’s clinical data across clinical studies. You will be an integrated member of the Relay Tx scientific team, responsible for in-house data management expertise for the execution of clinical studies that will translate Relay’s innovative science into impactful medicines for patients. You will report to the Senior Director, Clinical Data Management.

Requirements

• 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 but not limited to US CFR, EU CTD, ICH GCP, and CDISC.
• Experience in CRO and vendor oversight.
• Motivated self-starter who is capable of flourishing in a fast-paced small company environment.
• Creative problem-solver with excellent communication and public speaking skills.
• Strong interpersonal and organizational skills, with a high degree of attention to detail.
• Pragmatic and able to manage multiple projects and needs effectively.

Nice To Haves

• 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.

Responsibilities

• Oversight and execution of 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 for assuring the accuracy of clinical trial data, e.g., manual data review guidelines, computerized edit check programs, Data Management Plans (DMP).
• Responsible for executing or overseeing data cleaning activities through to database lock: includes generating and managing clinical trial data queries, data review listings, coding specified clinical trial data, e.g. adverse events and concomitant medications, reconciling serious adverse events and central labs.
• Collaborate with a dynamic Relay 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.

What This Job Offers

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