Associate 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.