Responsibilities
- The Clinical Lab Data Management Lead is responsible for managing the processing of external and/or local lab data received by the client throughout the clinical trial lifecycle.
- They provide subject matter expertise in external data handling of various external data sources (i.e., central laboratories, pharmacokinetic, immunogenicity, pharmacogenetic and biomarker samples, etc.)
- They provide support to the Lead Data Manager (LDM), Clinical Operations as well as the Biosamples management group with the review, maintenance, and management of external vendor.
- ESSENTIAL DUTIES AND RESPONSIBILITIES: Develop and maintain strong, collaborative relationships with internal study execution/management teams, CROs, laboratory service providers, and other key stakeholders
- Develop the Data Transfer Plan (DTP), including the Data Quality Review reconciliation section for the external vendor data transfer(s), obtain final approvals and file document to the Trial Master File (TMF) as applicable
- Develop and document external data edit checks and reports in the edit check template, obtain approvals and perform QC/UAT to verify the checks and reports are functioning properly
- Collaborate with external functional service provider counterparts for study expectations including milestones, deliverable timelines, communication expectations, etc
- Ensure electronic external vendor data transfers contain all protocol specified parameters, is in correct format, and data populates to the specified fields and subjects correctly as designated in the Vendor Data Plan (VDP)
- Review external data discrepancies generated by edit checks and reports and perform subsequent query management to resolve data issues
- Maintain appropriate documentation of data issues in both study and vendor logs and follow outcome to resolution
- May assist with review of draft protocols from an external data perspective and assist with review of eCRF design per protocol parameters
- Work with other study team functions to gather feedback and address any issues that could impact data review or analysis
- May work with clinical staff to obtain and QC local laboratory ranges and verify the normal ranges are properly attached to the subject results in the local lab data
- Participate in study team and department meetings as applicable
- Effectively plan and support multiple high quality external data management projects simultaneously and provide updates to line management or other relevant stakeholders as requested
- All other duties as needed or assigned
- Identifies and implements methods and procedures to achieve results
- Works independently and consults with management on decisions affecting project delivery as appropriate
- Drives the completion of milestones associated with specific projects
- Regular inter-organizational and outside contacts on routine matters
Job Type: Contract
Pay: $140,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Vision insurance
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
Application Question(s):
- Have you worked in Phase 2/3 studies ?
- Have you worked in Pharma/Biotech/CRO as Lab data manager ?
Work Location: Redwood City, CA 94063 (Hybrid)