Associate Director – Trial Master File
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Job Description
Associate Director overseeing Trial Master File operations for Crinetics Pharmaceuticals, ensuring compliance and inspection readiness across clinical documentation. Managing TMF staff and improving processes, systems, and culture in a matrixed environment.
Responsibilities:
- Provide leadership and oversight of TMF operations, ensuring inspection readiness and compliance with global regulations and internal standards.
- Manage and mentor TMF staff, fostering a culture of accountability, quality, and professional development.
- Oversee and optimize use of Veeva Vault eTMF and ensure alignment with business needs and best practices.
- Partner with Veeva Managed Services and Clinical Systems Manager to resolve issues, implement system enhancements, and ensure operational excellence.
- Lead TMF metrics and reporting, including completeness, timeliness, and quality, providing transparency to senior leadership.
- Serve as a subject matter expert for ICH GCP, GDocP, CDISC TMF Reference Model (formerly DIA TMF Reference Model), and global clinical trial regulations.
- Support with audits and regulatory inspections, including preparation, backroom support, and follow-up activities.
- Support CAPA management: drafting, implementation, tracking, and closure for TMF related quality events.
- Support authoring, reviewing, and maintaining SOPs, Work Instructions, and training materials, plans related to the TMF.
- Support in maintaining and performing change control on company TMF Content Map.
- Drive change management initiatives to improve TMF processes, systems, and culture in a matrixed environment.
- Partner with stakeholders on process improvement projects and conduct TMF training across clinical and study teams.
- Ensure proper TMF configuration and adoption that may have impact on adjacent Veeva Clinical Suite applications such as, CTMS, Site Connect, Study Training, Study Start-up.
- Collaborate cross-functionally to ensure TMF expectations are clearly defined, implemented, and monitored throughout study lifecycles.
- Other duties as assigned.
Requirements:
- Bachelor’s degree in Life Sciences, Healthcare, or related field required; advanced degree preferred.
- Minimum 10 years of experience in TMF Operations within the pharmaceutical, biotech, or CRO industry.
- A minimum of 7 years in a supervisory role
- Demonstrated people management experience, including performance management and team development.
- Proven expertise with Veeva Vault eTMF
- Experience working with Veeva Managed Services to implement improvements and resolve issues.
- Strong background in TMF metrics and reporting.
- Hands-on experience in audits/inspections (e.g., FDA, EMA, MHRA).
- Experience in CAPA lifecycle management.
- Proficiency in SOP and WI development, training, and implementation.
- Strong knowledge of ICH GCP, GDocP, global clinical trial regulations, and CDISC TMF Reference Model.
- Demonstrated ability to lead change management initiatives and influence in a matrixed environment.
- Strong interpersonal and communication skills, with the ability to partner effectively across functions and levels.
- Excellent organizational, analytical, and problem-solving skills with attention to detail.
Benefits:
- Health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance
- 20 days of PTO
- 10 paid holidays
- Winter company shutdown
- Discretionary annual target bonus
- Stock options
- 401k match
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