Associate Director, Clinical Data Management

The Opportunity:

As Associate Director, Data Management, you will be accountable for delivery, integrity, and quality of Relay’s clinical data across the clinical studies. You will be an integrated member of the Relay Tx scientific team, responsible for the 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.

Your Role:

You will be responsible for oversight and execution of data management activities for assigned clinical programs including data timelines and key deliverables.

You will work directly with and oversee CROs and vendors for outsourced Data Management activities. Is responsible for CRO performance and data management metrics for assigned programs.

You will lead database development and eCRF design, UAT, data import specifications, Case Report Form completion guidelines, data entry guidelines and related operations manuals.

You will 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).

You will be 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.

You will collaborate with a dynamic Relay cross-functional team to ensure timeliness and quality of data deliverables.

You will ensure compliance with global regulatory requirements and quality standards.

You will contribute to data standards including CRF and participate in data system development initiatives and database integration projects.

You will participate in SOP development, training of junior data managers, process mapping, and other departmental activities.

Your Background:

You should ideally have 7+ years of experience in the pharmaceutical / biotechnology industry as a Data Manager.  Sponsor experience is strongly preferred.

You have advanced experience with data collection and cleaning covering Phase I, II and III studies. Oncology experience is preferred.

You have experience in executing clinical studies across various phases is desirable.  Expertise in oncology drug development is preferred.

You have a strong and current knowledge in global regulatory and compliance requirements including but not limited to US CFR, EU CTD, ICH GCP, and CDISC.