Associate Director, Trial Master File Operations

Job Description:

Location:  This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

The Opportunity
This position is responsible for leading the TMF (Trial Master File) operations function for clinical trials across Praxis. To excel in this position, you are a strategic and collaborative leader capable of critically assessing and improving processes to meet rigorous quality standards. Ultimately, you are responsible for the completeness, accuracy, and regulatory compliance of TMFs.  As part of this responsibility, you oversee all TMF-related activities across all of Praxis’ clinical trials.  

Primary Responsibilities

• Lead the TMF Operations function to support Clinical Research and Development
• Manage and oversee the TMF Operations team, including hiring, training, and performance management
• Manage, provide direction, and maintain strong relationships with TMF third party vendors, including driving resolution of issues and remediation activities
• Oversee on-site TMF facilities and off-site records storage facilities, including ensuring compliant chain-of-custody procedures
• Develop and implement TMF processes and procedures, and TMF-related training materials that adhere to regulatory requirements and industry best practices
• Develop and maintain strong relationships with internal stakeholders, including acting as a subject matter expert for TMF operations and requirements
• Ensure timely and accurate setup, maintenance, and management of TMFs across all clinical trials
• Oversee development and maintenance of TMF Plans and content lists
• Ensure management of TMF access and user permissions
• Collaborate with cross-functional teams to ensure TMF completeness and accuracy throughout the trial lifecycle
• Manage the quality control of TMF documents according to GCP and regulatory requirements (ICH E6) from study start-up through inspection readiness and archival
• Monitor and report TMF metrics to senior management, proactively identifying areas for process improvement and implementing changes as needed
• Monitor and report on TMF completeness and readiness to Clinical Trial Teams, including study specific TMF review activities
• Serve as functional TMF inspection lead for regulatory inspections, providing relevant documents and information as required
• Conduct TMF quality reviews to identify root cause of performance issues, determine the appropriate remediation, and implement solutions as required
• Keep informed of regulatory changes and industry best practices related to TMF operations and coordinate with stakeholders to implement continuous operational excellence
• Serve as eTMF platform business owner, including managing eTMF system configuration changes in accordance with established change control processes and monitoring the impact of configuration changes to optimize performance
• Serve as sponsor archivist providing oversight of the contents and access to the archive

Qualifications and Key Success Factors

• Minimum of 8+ years of related experience with a Bachelor's degree
• Deep understanding of regulatory requirements (e.g., ICH-GCP, FDA, EMA) and industry best practices for TMF operations
• Extensive experience with electronic Trial Master File systems (Veeva strongly preferred) and related technology platforms
• Sound knowledge of DIA TMF Reference Model
• Effective knowledge of clinical trial operations and processes, preferred
• Demonstrated leadership skills to drive results
• Excellent communication skills and ability to collaborate with cross-functional teams to achieve results
• Ability to effectively manage priorities simultaneously and overdeliver
• Ability to travel as needed to meet business needs

The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position. The employee is regularly required to sit; use hands and fingers; reach with hands and arms; and talk and hear. The employee is occasionally required to stand, walk, and climb or balance. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus. Visual acuity is required to read and produce accurate materials. Use of keyboards and cellular devices.

Compensation & Benefits

At Praxis, we’re proud to offer an exceptional benefits package that includes:

• 99% premium cost covered for medical (Blue Cross Blue Shield), dental, and vision plans
• Bonus program structured to pay on a quarterly basis
• 401k plan with 100% match up to 6% of employee’s contribution (Traditional & Roth)
• Wellness benefit of $200/month towards incredibly flexible options including travel, fitness equipment & memberships, student loan repayment, sports fees and much more
• Unlimited PTO, (2) weeklong shutdowns each year, and a generous extended family leave benefit
• Eligibility for equity awards and Employee Stock Purchase Plan (15% discount)

To round out this world-class total rewards package, we provide annualized base salary compensation in the range listed below.  Final salary range may be modified commensurate with job level, education, and experience.

Annualized Base Salary

$160,000 - $190,000 USD