Crinetics Pharmaceuticals · 1 day ago
Associate Director, Trial Master File
United States
Full-time
Onsite
Lead/Staff, Director/Executive
$146K/yr - $182K/yr
10+ years expCrinetics Pharmaceuticals is a company focused on developing therapies for endocrine diseases and tumors. The Associate Director, Trial Master File will lead the TMF function, ensuring high-quality clinical documentation and compliance with regulations while managing a team and optimizing TMF processes.
BiotechnologyHealth CarePharmaceuticalTherapeutics
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
Qualification
Required
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
Preferred
Experience with working with Veeva CTMS, Site Connect, Study Training, Study Start-up in relation to TMF process flows
Experience in process transformation and implementation of tools to streamline TMF operations
Familiarity with risk-based TMF management approaches
Experience in global/multi-regional clinical trial environments
Strong project management skills and ability to balance multiple priorities in a fast-paced environment
Benefits
Discretionary annual target bonus
Stock options
ESPP
401k match
Top-notch 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
Company
Crinetics Pharmaceuticals
Crinetics is a clinical-stage pharmaceutical company that develops therapies for people with rare endocrine diseases.
501-1000 employees
Funding
Current Stage
Public CompanyTotal Funding
$2BKey Investors
Frazier Healthcare PartnersNational Institutes of HealthPerceptive Advisors
2026-01-07Post Ipo Equity· $349.22M
2024-10-08Post Ipo Equity· $500M
2024-02-28Post Ipo Equity· $350M
Leadership Team
R. Scott Struthers
Founder, CEO
A
Alan S. Krasner
Chief Endocrinologist
Recent News
2026-01-07
2026-01-07
Company data provided by crunchbase