Trial Master File Manager (Biotech / Oncology)

SUMMARY/JOB PURPOSE:

The Trial Master File Manager (TMF Manager) supports TMF Leadership with day-to-day TMF operational activities to ensure the TMF is in Good Health (complete, accurate and contemporaneous) and is Inspection Ready. The TMF Manager makes an immediate impact and champions the value of inspection readiness and GCP Compliance with Health Authority regulations. The TMF Manager is also the named TMF Archivist who serves as the SME for study closure activities and the archival of studies.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Contributes to the process improvement of TMF tasks: filing, quality control, remediation, metrics, study closures and archiving.
• Manages the TMF Reference Model structure and how it is utilized at Exelixis.
• Serves as the TMF Archivist to support study-specific clinical oversight of the TMF from active to closed state to ensure the studies are archived appropriately,
• Fosters effective relationships with stakeholder functions to achieve TMF objectives and serve as a subject matter expert on TMF across all functions involved in clinical trial execution.
• Reviews clinical trial document quality control activities and monthly metrics to ensure that study TMFs are inspection ready.
• Collaborates across multiple functions supporting clinical trial processes to ensure adherence to regulatory requirements for maintenance of compliant TMFs and identify efficiency opportunities.
• Identifies and suggests improvements to elevate TMF capabilities and standards and establish the necessary procedures to implement these changes.
• Provides training to both internal and CRO teams on TMF technical aspects and eTMF features.
• Contributes to and engages TMF Management team in process development, innovative problem solving, and TMF-specific training initiatives.
• Maintains continuous knowledge of the regulatory requirements and industry trends related to TMF compliance.
• Ensures study team members (internal and CRO) are remediating quality inquiries as per published business targets.
• Supports the development of TMF related SOPs, WIs, Job Aids and guidance documents.
• Works closely with TMF technical team to monitor the TMF health for active studies for potential trends.
• Supports overall goals and objects of the function and company.
• Undertakes additional assignments and stretch projects to support the TMF operational excellence in TMF operations and clinical compliance.
• Steps in to help support department business needs during peak times as a TMF Study Lead when needed.

SUPERVISORY RESPONSIBILITIES:

• None

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• BS/BA degree in related discipline and a minimum of seven years of related experience; or,
• MS/MA degree in related discipline and a minimum of fiveyears of related experience; or,
• Equivalent combination of education and experience.

Experience/The Ideal for Successful Entry into Job:

• 6+ years of experience working in a pharmaceutical or other highly regulated corporate environment, including 5+ year in experience using electronic records management systems, with progressive experience managing active, inactive, and archived records, analyzing business processes, and developing and implementing TMF and Records Management policy 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.
• Experienced with TMF and knowledgeable about FDA and other Health Authority regulations around the management of the TMF.
• Exceptional project management skills and experience managing a portfolio of multiple products, and prioritization of activities and resources.
• Strong understanding of the ICH/GCP guidelines, all applicable laws and regulations as it pertains to TMF, and Exelixis SOPs, for all active studies.

Knowledge/Skills:

• Expert knowledge of TMF for set-up and maintenance. Knowledge of eTMF systems are desirable.
• Must be a self-starter, quick learner, strong collaborator, and team player with ability to work independently with minimal supervision.
• 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.
• Must have excellent analytical, strategic thinking, problem-solving, time management, change management and organizational skills with demonstrated ability to work in a fast-paced environment and adapt to changing business plans and priorities.
• Self-motivation, eagerness to grow professionally and commitment to self-development.
• Ability to proactively identify potential issues and formulate potential course(s) of action.

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.

WORKING CONDITIONS:

• Occasional travel may be required.

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