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The Trial Master File (TMF) Sr. Specialist is responsible for providing support to the TMF function, study teams, and external vendors to ensure quality TMF records are being collected and filed for the purpose of internal and/or external audit and regulatory/health authority inspection. The TMF Sr. Specialist ensures adherence to established TMF Plans and associated indices, standard operating procedures (SOPs), Corporate policies, and ICH GCP/regulatory guidelines, and promotes a continuous state of inspection readiness and TMF best practices.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Manages processes and procedures for TMF management, review, transfer, and archival of records and ensures consistency in process across all Exelixis programs and studies.
Routinely processes TMF records submissions for adherence to established TMF Plans and indices and verifies acceptability of records, level of filing, document type, and required metadata; tracks and catalogs receipt of records (paper and electronic)
Confirms records which fail submissions review are queried to the study teams and/or external vendors and tracked for response/action; ensures queries are resolved and required actions taken to proceed with submissions processing and to promote records to a final published state or filing in paper files
Ensures TMFs are in a continuous state of inspection readiness and trial master file records are filed in a timely manner, in accordance with associated milestones
Conducts periodic and/or Sponsor bi-annual reviews of the TMF to ensure core metrics for completeness, timeliness, and quality of the TMF are met; reconciles all records, identifies findings/issues, and ensures remediation activities are performed for review closure and certificate issuance
Performs a final TMF review following study close-out activities, identifies issues/findings, and completes remediation and/or corrective actions for TMF closure and archival.
Assists in the development and update of established SOPs, WIs, and tools (reference materials, flowcharts, guidance’s, checklists, etc.)
Provides training and mentorship to internal teams and external vendors as required
Promotes process improvement and routinely assesses current work practice ensuring alignment across team activities and initiatives; provides assessment outcome and initiates SOP and/or training material/guidance updates
Represents the TMF function at study team meetings, collaborates, and plays an important cross-functional role in TMF document retrieval and management; actively provides TMF status updates and metrics for milestone and overall percent completion, generates status reports as needed, and provides any requested information to study teams
Provides support to the Compliance team and QA functions during audits and/or regulatory inspections, as directed by the TMF Head
Coordinates end of study TMF/eTMF final transfers from external vendors; reviews records and the associated metadata, confirms receipt of all intended records and paper/media contents, and provides completed TMF final transfer acceptance of receipt to the external vendor.
Establishes and maintains accurate listings for off-site storage of TMF records and routinely verifies continuance of records storage according to corporate policy and regulatory requirements
Periodically reviews study specific approved TMF indices and collaborates with Clinical Trial Leads and TMF Head to implement updates, as necessary for the addition or closure of document types planned for collection
Assists with any additional TMF associated projects as needed
SUPERVISORY RESPONSIBILITIES:
Provides mentorship and guidance to junior level staff, external vendors, and/or temporary contract employees
EDUCATION/EXPERIENCE/SKILLS:
Education:
BS/BA degree in related discipline and 3+ years of related experience; or,
Masters degree in related discipline and 1+ years of related experience; or,
Equivalent combination of education and experience
Experience:
4+ years of experience working in a pharmaceutical or other highly regulated corporate environment, including 2+ year in experience using electronic records management systems, with progressive experience managing active, inactive, and archived records, analyzing business processes, and developing and implementing Records Management policy and procedures
Stringent background in FDA regulated records management and ability to design and develop record-keeping systems, policies, and procedures
Broad understanding of business processes in a wide variety of functional areas within a large, international pharmaceutical company, and the ability to translate the records management needs of those business processes into clear and concise terminology, logical and hierarchical arrangements of records types and series, and clear and effective procedures for filing and managing both records and non-records.
Knowledge/Skills/Abilities:
Expert knowledge of TMF for set-up and maintenance. Knowledge of eTMF systems are desirable.
Background in EDC and CTMS systems desirable.
Good communication skills both oral and written are a must. Applies strong analytical and business communication skills.
Excellent attention to detail, strong critical thinking, and problem solving
Excellent organizational, time management, and project management skills.
Strong working knowledge of GCP/ICH regulations and guidelines
Applies technical standards, principles, theories, concepts, and techniques.
Excellent organizational skills are required.
Demonstrated success in problem solving and critical analysis
Good computer skills are required. Working knowledge of MS Word, Excel, and PowerPoint is required, and applications as needed for job.
Ability to work in a team environment.
Self-motivation, eagerness to grow professionally and commitment to self-development.
Ability to proactively identify potential issues and formulate potential course(s) of action.
Occasional travel may be required.
JOB COMPLEXITY:
Works on assigned problems of moderate scope with analysis of situation or data required.
Exercises judgment within defined procedures and practices to determine appropriate action.
Builds productive internal and external working relationships.
Uses professional concepts and company’s policies and procedures to solve a variety of routine problems.
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DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
