Manager, Clinical Trial TMF

POSITION SUMMARY:

The Manager of Trial Master File (TMF) Operations is responsible for the overall management, quality, and compliance of the TMF in accordance with Good Clinical Practice (GCP) guidelines, regulatory requirements, and company policies. This role involves managing TMF systems, process oversight and optimization, and supporting the inspection readiness of clinical trials in adherence to the requirements of study protocols. The TMF Manager collaborates with various stakeholders to ensure all clinical trial documentation is complete, accurate, and inspection ready.

 

PRIMARY RESPONSIBILITIES:

● Manage a team of 1 - 4 TMF Specialists, full time and/or contractors, who perform TMF tasks
across studies in Natera’s business units
● Responsible for building an effective team; identifying, recruiting, and vetting candidates, and for
the professional development of full-time direct reports.
● Ensure that direct and/or functional reports are coached and trained to comply with procedures,
requirements, and company policies.
● Be a thought leader in the TMF domain as it applies to Natera’s unique studies.
● Provide direction and training to relevant functional areas on TMF processes, regulatory
requirements, and best practices.
● Develop, maintain, and facilitate TMF standard operating procedures (SOPs), TMF document
templates (plans, indices, checklists), and other guidance documents.
● Develop and review study-specific TMF plans to ensure compliance with industry standard and
Natera SOPs.
● Lead and facilitate story boarding to ensure the TMF reflects its study accurately and that decisions,
challenges, and gaps are adequately accounted for.
● Support internal and external audits and inspections as the TMF subject matter expert.
● Track study KPIs and generate regular TMF status reports, including metrics on document
completeness, quality, and timelines.
● Manage user access in electronic TMF (eTMF), ensuring proper permissions and system security.
● Support the implementation of new TMF systems or upgrades, addressing user challenges, and
coordinating with IT and vendor teams as necessary.
● Manage and maintain the Trial Master File (TMF) throughout the lifecycle of clinical trials, including
setup, maintenance, and archiving.
● Oversee regular quality checks of the TMF to ensure consistency, accuracy, and completeness of
documentation as well as compliance with regulatory requirements and GCP guidelines.

● Identify and resolve any issues or discrepancies in the TMF, implementing corrective and
preventive actions as needed.
● Employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure
Compliance training and security training as soon as possible but not later than the first 30 days of
hire.
● Performs other duties as assigned

 

QUALIFICATIONS:

● Minimum Education Requirement: Bachelor’s degree in a related field of study.
● 8 + years of experience in clinical research, with a strong background in TMF management.
● In-depth knowledge of GCP, ICH guidelines, and regulatory requirements related to clinical trial
documentation.
● Experience with international trials is preferred.
● Experience in leading or supporting audits and inspections.
● Experience leading people to achieve aggressive timelines with high quality.
● Proven record of working effectively with and across business areas (clinical science, quality
assurance, data management, regulatory, legal, business development, etc.).

 

KNOWLEDGE, SKILLS, AND ABILITIES:

● Highly effective verbal and written communication skills.
● Detail oriented, with solid organization, planning, and time management skills.
● Demonstrated analytical skills and ability to identify problems and propose solutions.
● Must be self‐motivated with a demonstrated ability to work independently.
● Ability to manage multiple projects and priorities in a fast-paced environment.
● Strong customer focus.

 

PHYSICAL DEMANDS & WORK ENVIRONMENT

● This position requires the ability to use a computer keyboard, communicate over the telephone

and read printed material.
● Duties may require working outside normal working hours (evenings and weekends) at times.

 

Travel required for this position:
No _ or Yes __X_: If yes state anticipated percent for travel: Up to 25%

The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations.San Carlos, CA $131,080.40—$163,850.50