Senior Manager, Clinical Data Management - External Data Management
Crinetics Pharmaceuticals
5 months ago
Remote friendly (United States)
United States
Clinical Research and Development
Position Summary:
- Senior Manager, Clinical Data Management – External Data Management (CDM‑EDM): Execute and own external (non‑EDC) data management activities for assigned clinical studies to ensure vendor data are timely, high quality, inspection-ready, and fit for statistical analysis and regulatory submission.
Responsibilities:
- Develop and maintain Data Transfer Agreements (DTAs) and external data specifications for external sources (e.g., central labs, PK/biomarkers, ECG, imaging, eCOA, IRT, CTMS).
- Coordinate and perform test data transfers, including hands-on QC and approval prior to production flow.
- Establish and manage external data transfer schedules and reconciliation cycles aligned with study milestones.
- Import, validate, and reconcile external datasets for completeness, accuracy, and consistency.
- Perform ongoing external data cleaning and reconciliation (discrepancies, investigation, resolution with vendors).
- Use SAS (or similar) and data visualization tools for data review, validation, and reconciliation.
- Serve as the primary external data contact for vendors and CRO partners.
- Troubleshoot issues with vendor data management teams; ensure timely, high-quality delivery.
- Monitor vendor performance (quality/timelines) and escalate issues as needed.
- Act as the 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, transfer logs, reconciliation records, external data management plans).
- Ensure compliance with ICH‑GCP, 21 CFR Part 11, CDISC standards, and internal SOPs.
- Support regulatory inspections and audits as SME.
Required Qualifications:
- MS/BS in life sciences, health informatics, computer science, or related field.
- 8+ years progressive clinical data management experience with deep, hands-on external (non‑EDC) data management and direct vendor/CRO execution (or 12+ years with Bachelor’s only).
- Experience independently managing complex external data across the full clinical data lifecycle (startup through database lock, submission support, and archiving).
- Proven expertise as external data subject matter expert for studies with multiple vendors/data streams.
- Strong knowledge of EDC systems, external data transfers, CDISC (CDASH/SDTM), and clinical data regulations.
- Hands-on SAS experience (or equivalent) for validation, reconciliation, and issue investigation.
- Solid understanding of ICH‑GCP, 21 CFR Part 11, and inspection expectations.
- Ability to work independently with minimal oversight while managing multiple priorities.
Preferred Qualifications:
- Experience supporting late-phase and/or submission-supporting studies (external data readiness for analyses and milestones).
- Process improvement experience (e.g., SOPs/templates/inspection readiness).
- Exposure to lab operations/bio-sample management and lab data flows.
- BASE SAS Certified Programmer (required or strongly preferred).
- CCDM (or equivalent) certification.
Benefits (explicitly stated):
- 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): Execute and own external (non‑EDC) data management activities for assigned clinical studies to ensure vendor data are timely, high quality, inspection-ready, and fit for statistical analysis and regulatory submission.
Responsibilities:
- Develop and maintain Data Transfer Agreements (DTAs) and external data specifications for external sources (e.g., central labs, PK/biomarkers, ECG, imaging, eCOA, IRT, CTMS).
- Coordinate and perform test data transfers, including hands-on QC and approval prior to production flow.
- Establish and manage external data transfer schedules and reconciliation cycles aligned with study milestones.
- Import, validate, and reconcile external datasets for completeness, accuracy, and consistency.
- Perform ongoing external data cleaning and reconciliation (discrepancies, investigation, resolution with vendors).
- Use SAS (or similar) and data visualization tools for data review, validation, and reconciliation.
- Serve as the primary external data contact for vendors and CRO partners.
- Troubleshoot issues with vendor data management teams; ensure timely, high-quality delivery.
- Monitor vendor performance (quality/timelines) and escalate issues as needed.
- Act as the 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, transfer logs, reconciliation records, external data management plans).
- Ensure compliance with ICH‑GCP, 21 CFR Part 11, CDISC standards, and internal SOPs.
- Support regulatory inspections and audits as SME.
Required Qualifications:
- MS/BS in life sciences, health informatics, computer science, or related field.
- 8+ years progressive clinical data management experience with deep, hands-on external (non‑EDC) data management and direct vendor/CRO execution (or 12+ years with Bachelor’s only).
- Experience independently managing complex external data across the full clinical data lifecycle (startup through database lock, submission support, and archiving).
- Proven expertise as external data subject matter expert for studies with multiple vendors/data streams.
- Strong knowledge of EDC systems, external data transfers, CDISC (CDASH/SDTM), and clinical data regulations.
- Hands-on SAS experience (or equivalent) for validation, reconciliation, and issue investigation.
- Solid understanding of ICH‑GCP, 21 CFR Part 11, and inspection expectations.
- Ability to work independently with minimal oversight while managing multiple priorities.
Preferred Qualifications:
- Experience supporting late-phase and/or submission-supporting studies (external data readiness for analyses and milestones).
- Process improvement experience (e.g., SOPs/templates/inspection readiness).
- Exposure to lab operations/bio-sample management and lab data flows.
- BASE SAS Certified Programmer (required or strongly preferred).
- CCDM (or equivalent) certification.
Benefits (explicitly stated):
- 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%.