Director, Global Trial Master File
Incyte
9 hours ago
Remote friendly (Wilmington, DE)
United States
Clinical Research and Development
Job Summary / Primary Function
- Provide enterprise leadership for Trial Master File (TMF) strategy, governance, and execution across a global clinical portfolio.
- Accountable for end-to-end TMF operations, including oversight of internal teams, FSPs, CRO partners, and enabling technologies.
- Ensure inspection readiness, regulatory compliance, scalable operations, and continuous improvement/modernization of TMF practices.
Key Responsibilities
- Define and lead global TMF strategy, governance framework, and operating model.
- Establish inspection-readiness standards aligned with ICH-GCP and global regulations.
- Serve as escalation point for TMF risks, compliance issues, and inspection outcomes.
- Lead and develop a global TMF team across regions and partners; drive workforce planning, capability building, and performance management.
- Ensure consistent TMF execution across studies, CROs, and regions.
- Own KPIs, quality metrics, and timeliness of TMF deliverables.
- Oversee TMF consolidation, archival, and retention strategies.
- Lead TMF support for regulatory inspections and internal audits; review findings, approve CAPAs, and ensure sustainable remediation.
- Own global TMF SOPs, work instructions, and TMF Index Model.
- Drive system optimization (e.g., Veeva Vault) and digital innovation; use automation and data insights to improve TMF quality and efficiency.
Qualifications
- Degree (e.g., Bachelor’s) or equivalent experience required; advanced degree or equivalent experience preferred.
- 8–10+ years (or equivalent) in TMF or clinical document management.
- Experience managing global teams and vendors.
- Strong knowledge of ICH-GCP and regulatory requirements.
- Experience with eTMF systems (e.g., Veeva Vault or similar).
- Familiarity with CDISC TMF Reference Model.
- Strong leadership, communication, and problem-solving skills.
- Experience in global, matrixed organizations.
- Travel up to 20% (domestic/international).
- Provide enterprise leadership for Trial Master File (TMF) strategy, governance, and execution across a global clinical portfolio.
- Accountable for end-to-end TMF operations, including oversight of internal teams, FSPs, CRO partners, and enabling technologies.
- Ensure inspection readiness, regulatory compliance, scalable operations, and continuous improvement/modernization of TMF practices.
Key Responsibilities
- Define and lead global TMF strategy, governance framework, and operating model.
- Establish inspection-readiness standards aligned with ICH-GCP and global regulations.
- Serve as escalation point for TMF risks, compliance issues, and inspection outcomes.
- Lead and develop a global TMF team across regions and partners; drive workforce planning, capability building, and performance management.
- Ensure consistent TMF execution across studies, CROs, and regions.
- Own KPIs, quality metrics, and timeliness of TMF deliverables.
- Oversee TMF consolidation, archival, and retention strategies.
- Lead TMF support for regulatory inspections and internal audits; review findings, approve CAPAs, and ensure sustainable remediation.
- Own global TMF SOPs, work instructions, and TMF Index Model.
- Drive system optimization (e.g., Veeva Vault) and digital innovation; use automation and data insights to improve TMF quality and efficiency.
Qualifications
- Degree (e.g., Bachelor’s) or equivalent experience required; advanced degree or equivalent experience preferred.
- 8–10+ years (or equivalent) in TMF or clinical document management.
- Experience managing global teams and vendors.
- Strong knowledge of ICH-GCP and regulatory requirements.
- Experience with eTMF systems (e.g., Veeva Vault or similar).
- Familiarity with CDISC TMF Reference Model.
- Strong leadership, communication, and problem-solving skills.
- Experience in global, matrixed organizations.
- Travel up to 20% (domestic/international).