Manager Clinical Data Management

About:

Meet is working with a pre-IPO clinical stage biopharmaceutical company focused on cancer, autoimmune, and other serious diseases. Reporting to the Director of Clinical Data Management, you would be providing oversight of clinical data management activities from study start-up through study closure in support of trial objectives and corporate goals. Local candidates to the Bay Area are preferred, but will consider remote candidates with some travel required.

Role and Responsibilities:

• Provides oversight of clinical data management activities across one or more studies
• Leads the development or co-development with CRO and maintenance of clinical data management documents, including but not limited to: Data Management Plans, Case Report Forms (CRF), CRF Completion guidelines, edit check specifications, data transfer specifications, and report specifications.
• Oversight of DM CRO data management activities.
• Partner with the CRO and EDC vendor(s) to ensure the timely design and development of clinical study databases per study requirements, including system integrations.
• Performs and organizes cross-functional User Acceptance Testing (UAT) of clinical databases and integrations.
• Reviews clinical study documents including but not limited to: Clinical Protocols, Data Transfer Specifications/Agreements, Study Plans, Project Timelines
• Leads discussions with clinical data management partners/vendors to ensure that data management tasks and deliverables remain on target per project timelines.
• Manages ongoing data review and data reconciliation throughout the conduct of the study to ensure timely and appropriate identification of errors, trends, and discrepancies, in collaboration with internal and external stakeholders
• Responsible for the correction of errors and discrepancies through the query process, for documenting permanent data issues, routinely communicating issues with team members.
• Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors, and the ability to work through ambiguity
• Help to ensure DM documentation is uploaded into the TMF and ensure inspection readiness.
• Ensure compliance with SOPs, Good Clinical Practice (ICH-GCP), and applicable regulatory requirements.
• Contribute to writing SOPS, Working Practices, and Guidelines.
• Attend and present at Investigator Meetings and other industry meetings as needed.
• Responsible for implementing analytics tools for one or more clinical trials.

Education, Experience, and Qualification Requirements:

• Bachelor’s degree in clinical, biological, mathematical sciences or related field is required; an advanced degree is a plus
• Minimum of 5 years of clinical data management experience in the biopharmaceutical industry on the Sponsor side; advanced knowledge of Data Management processes and systems
• Solid understanding of clinical drug development processes
• Minimum of 5 years of Auto Immune or Oncology Experience
• Minimum 5 years of Electronic Data Capture (EDC) experience (preference for Medidata Rave X experience); IXRS integration experience required
• Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials.
• Detail-oriented, strong multi-tasking, and time management skills are required due to deadlines.
• Microsoft office suite (excel, powerpoint, word, outlook)
• Smartsheet
• Willingness to travel up to 20%
• Permitted to work in the United States

Please reach out to [email protected] if you believe your experience aligns.