7+ years of experience in pharmaceutical/biotechnology as a Data Manager, preferably with sponsor experience.
Advanced experience in data collection and cleaning for Phase I, II, and III studies, with a preference for oncology.
Experience executing clinical studies across various phases, particularly in oncology drug development.
Strong knowledge of global regulatory and compliance requirements (US CFR, EU CTD, ICH GCP, CDISC).
Experience in CRO and vendor oversight.
Self-starter capable of thriving in a fast-paced, small company environment.
Creative problem-solver with excellent communication and public speaking skills.
Strong interpersonal and organizational skills with attention to detail.
Responsibilities
Oversee and execute data management activities for assigned clinical studies, ensuring timelines and deliverables are met.
Manage CROs and vendors for outsourced data management activities, focusing on performance and metrics.
Lead database development, eCRF design, and related operational guidelines.
Develop data validation specifications and programs to ensure clinical trial data accuracy.
Execute or oversee data cleaning activities through to database lock, including query generation and data reconciliation.
Collaborate with cross-functional teams to ensure timely and quality data deliverables.
Ensure compliance with global regulatory requirements and quality standards.
Contribute to data standards and participate in data system development initiatives.
Benefits
Opportunity to work in a dynamic and innovative environment.
Collaboration with a cross-functional team.
Involvement in impactful clinical studies that translate science into medicines.
Professional development opportunities, including training of junior data managers.
Full Job Description
Associate Director, Clinical Data Management
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 Clinical Data Management 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 Executive Director, Clinical Data Management.
Your Role:
You will be responsible for oversight and execution of data management activities for the assigned clinical study 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, reconciling serious adverse events, coding, central and local lab data, and external data.
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.
You have experience in CRO and vendor oversight.
You are a motivated self-starter who is capable of flourishing in a fast-paced small company environment and able to work independently.
You are a creative problem-solver with excellent communication and public speaking skills.
You have strong interpersonal and organizational skills, with a high degree of attention to detail.
You are pragmatic and able to manage multiple projects and needs effectively.
Estimated Salary Range: [$147,000 - $210,000].
The range provided above is based on what we believe to be a reasonable estimate for this job at the time of posting. Actual base salary will depend on a number of factors, including but not limited to, a candidate's education, experience, skills and location.
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About Relay Therapeutics
Relay Therapeutics is a biotechnology company that develops new medicines using computational techniques. The company's platform combines computational simulations with experimental data to design new drugs that target specific proteins. Relay Therapeutics' technology can help accelerate the drug discovery process and reduce the time and cost of bringing new drugs to market. The company was founded in 2016 and is based in Cambridge, Massachusetts.
