Associate Director TMF Management & Inspection Readiness

Princeton, NJ - USA

Monthly Salary: Not Disclosed

Posted on: 2 days ago

Vacancies: 1 Vacancy

Job Summary

Please note that this position can be based inSan Diego CA OR San Francisco CA OR Princeton NJ. Acadias hybrid model requires this role to work in our office three days per week on average.

Position Summary

The Associate Director Trial Master File (TMF) Oversight & Inspection Readiness (IR) is responsible for leading the operational oversight of the TMF and supporting the framework that ensures Trial Master File integrity sustained inspection readiness and regulatory compliance within Clinical Operations. This role leads TMF health governance inspection preparedness and risk identification processes to safeguard the organization during regulatory inspections and audits. The Associate Director serves as the Clinical Operations lead for inspection defense by advancing consistent standards proactive risk visibility and clear organizational insight into TMF integrity and inspection readiness.

Primary Responsibilities

TMF Oversight & Governance

Establish TMF health oversight framework across studies ensuring compliance with GCP and industry standards.
Monitor TMF quality metrics across programs ensuring completeness timeliness and accuracy of essential documents; Escalate any TMF metrics falling outside of KPIs to appropriate stakeholders for resolution and corrective action.
Lead and share TMF best practices with internal and external stakeholders as TMF risk trending and remediation plans.

Maintain inspection-readiness standards for documentation.

Inspection Readiness Leadership

Develop and maintain a sustainable inspection readiness model including development and maintenance of comprehensive inspection readiness tools reference materials and coordinating training guidance to staff on preparation efforts for health authority inspections.
Lead inspection storyboarding and narrative inspection preparation designated Clinical Operations activities during regulatory inspections.
Support post-inspection CAPA alignment in partnership with Quality.
Support Clinical Operations team on all inspection commitments responses post-inspection activities and implementation of corrective and preventative actions; provide lessons learned from mock and actual inspections. Ensure portfolio-level visibility of inspection risk.

Other Responsibilities

Partner cross-functionally to align on audit and inspection strategy as well as TMF platform with functional study teams on TMF accountability awareness of industry trends and developments to help define the future strategic direction for TMF and Inspection Readiness.
Other responsibilities as required.

Education/Experience/Skills

Bachelors degree in life sciences or related field; Advanced degree preferred. Targeting at least 8 years pharmaceutical industry and/or clinical research organization experience with at least 5 years TMF experience in a leadership role. Health Authority inspection and eTMF experience is required. An equivalent combination of relevant education and experience may be considered.

Key Skills

Thorough understanding of GCP and ICH guidelines; thorough understanding of the drug development process.
Knowledge and understanding of the current regulatory requirements (e.g. FDA EMA MHRA) in a global environment.
Thorough understanding of the CDISC TMF Reference model; direct experience with the TMF Reference Model working group is preferred.
Veeva Vault eTMF/CTMS experience preferred.
Ability to lead motivate and influence others including prior leadership experience is strongly preferred.
Adept at creating and communicating a clear vision among effectively aligning resources and motivating stakeholders to achieve goals.
Demonstrated analytical abilities and proficient planning and negotiation skills. Demonstrated technical administrative and project management capabilities.
Strong interpersonal organizational and workload planning skills along with excellent verbal and written communication skills.
Demonstrated success with cross-functional collaboration and managing multiple assignments with timely and accurate output. Demonstrated problem-solving abilities with strong attention to detail.
Able and willing to travel both domestically and internationally.

Physical Requirements

While performing the duties of this job the employee is regularly required to stand; walk; sit; use hands to finger handle or feel; reach with hands and arms; climb or balance; stoop kneel crouch see talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds. Ability to travel independently overnight and work after hours if required by travel schedule or business needs.

#LI-Hybrid #LI-SL1

Required Experience:

Director

Please note that this position can be based inSan Diego CA OR San Francisco CA OR Princeton NJ. Acadias hybrid model requires this role to work in our office three days per week on average.Position SummaryThe Associate Director Trial Master File (TMF) Oversight & Inspection Readiness (IR) is respon...