Senior Manager, Clinical Data Management - External Data Management
Crinetics Pharmaceuticals
9 hours ago
Remote friendly (United States)
United States
Clinical Research and Development
Position Summary
Senior Manager, Clinical Data Management – External Data Management (CDM‑EDM): Hands-on, individual contributor role executing and owning external (non‑EDC) data management activities for assigned clinical studies. Ensures external vendor data are timely, high quality, inspection-ready, and fit for statistical analysis and regulatory submission.
Essential Job Functions and Responsibilities
- Develop and maintain Data Transfer Agreements (DTAs) and external data specifications (e.g., central labs, PK/biomarkers, ECG, imaging, eCOA, IRT, CTMS).
- Coordinate and perform test data transfers with hands-on QC and approval prior to production flow.
- Establish/manage external data transfer schedules and reconciliation cycles aligned to study milestones.
- Import, validate, and reconcile external datasets for completeness, accuracy, and consistency.
- Perform ongoing external data cleaning and reconciliation; identify discrepancies and resolve issues with vendors.
- Use SAS (or similar) and data visualization tools for data review, validation, and reconciliation.
- Serve as primary external data contact for vendors/CRO partners; troubleshoot vendor data issues.
- Monitor vendor data quality/timelines and escalate as needed.
- Act as external data management lead on study teams.
- Collaborate with Clinical Operations, Biostatistics, Statistical Programming, Safety, and Regulatory to ensure data readiness.
- Maintain inspection-ready documentation (DTAs, logs, reconciliation records, external data management plans).
- Ensure compliance with ICH‑GCP, 21 CFR Part 11, CDISC standards, and internal SOPs.
- Support regulatory inspections/audits as SME.
Required
- MS/BS in life sciences/health informatics/computer science or related; 8+ years clinical data management with deep external (non‑EDC) data management and direct vendor/CRO execution (or 12+ years with BS).
- Independent management of complex external data across the clinical lifecycle (startup through database lock, submission support, archiving).
- External data SME experience across multiple vendors/data streams.
- Strong knowledge of EDC systems, external data transfers, CDISC (CDASH/SDTM), and clinical data regulations.
- Hands-on SAS for validation, reconciliation, and issue investigation.
- Solid understanding of ICH‑GCP and 21 CFR Part 11.
Preferred
- Late-phase and/or submission-support experience; ownership of external data readiness.
- Process improvement contributions (SOPs/templates/inspection-readiness).
- Lab operations/bio-sample management exposure.
- BASE SAS Certified Programmer; certification such as CCDM (or equivalent).
Benefits (if applicable)
- Discretionary annual target bonus, stock options, ESPP, 401k match; medical/dental/vision/basic life; 20 days PTO, 10 paid holidays, winter company shutdown.
Travel
- Up to 5%.
Senior Manager, Clinical Data Management – External Data Management (CDM‑EDM): Hands-on, individual contributor role executing and owning external (non‑EDC) data management activities for assigned clinical studies. Ensures external vendor data are timely, high quality, inspection-ready, and fit for statistical analysis and regulatory submission.
Essential Job Functions and Responsibilities
- Develop and maintain Data Transfer Agreements (DTAs) and external data specifications (e.g., central labs, PK/biomarkers, ECG, imaging, eCOA, IRT, CTMS).
- Coordinate and perform test data transfers with hands-on QC and approval prior to production flow.
- Establish/manage external data transfer schedules and reconciliation cycles aligned to study milestones.
- Import, validate, and reconcile external datasets for completeness, accuracy, and consistency.
- Perform ongoing external data cleaning and reconciliation; identify discrepancies and resolve issues with vendors.
- Use SAS (or similar) and data visualization tools for data review, validation, and reconciliation.
- Serve as primary external data contact for vendors/CRO partners; troubleshoot vendor data issues.
- Monitor vendor data quality/timelines and escalate as needed.
- Act as external data management lead on study teams.
- Collaborate with Clinical Operations, Biostatistics, Statistical Programming, Safety, and Regulatory to ensure data readiness.
- Maintain inspection-ready documentation (DTAs, logs, reconciliation records, external data management plans).
- Ensure compliance with ICH‑GCP, 21 CFR Part 11, CDISC standards, and internal SOPs.
- Support regulatory inspections/audits as SME.
Required
- MS/BS in life sciences/health informatics/computer science or related; 8+ years clinical data management with deep external (non‑EDC) data management and direct vendor/CRO execution (or 12+ years with BS).
- Independent management of complex external data across the clinical lifecycle (startup through database lock, submission support, archiving).
- External data SME experience across multiple vendors/data streams.
- Strong knowledge of EDC systems, external data transfers, CDISC (CDASH/SDTM), and clinical data regulations.
- Hands-on SAS for validation, reconciliation, and issue investigation.
- Solid understanding of ICH‑GCP and 21 CFR Part 11.
Preferred
- Late-phase and/or submission-support experience; ownership of external data readiness.
- Process improvement contributions (SOPs/templates/inspection-readiness).
- Lab operations/bio-sample management exposure.
- BASE SAS Certified Programmer; certification such as CCDM (or equivalent).
Benefits (if applicable)
- Discretionary annual target bonus, stock options, ESPP, 401k match; medical/dental/vision/basic life; 20 days PTO, 10 paid holidays, winter company shutdown.
Travel
- Up to 5%.