Director, Trial Master File

Job Description

The Director, Trial Master File is responsible for developing the processes and strategy for global Trial Master File (TMF) management. Responsibilities include the daily oversight of TMF activities and TMF staff to ensure regulatory inspection-readiness and compliance with applicable regulations. The Director is also responsible for planning, developing, and implementing the TMF onsite and offsite, paper and electronic storage ensuring and protection of the TMF. The Director is responsible for leading the implementation of the eTMF system and providing training to Development staff as needed.

Qualifications

ESSENTIAL DUTIES AND RESPONSIBILITIES: Establishes and manages the quality oversight of TMF including quality checks and TMF metrics and KPIs. Oversees and manages the process for filing, retrieving, storing, preserving, and protecting of TMF records (paper and electronic). Oversees staff to ensure that all physical and electronic records, on-site and off-site are controlled and accurately catalogued and filed. Represents manager on key task forces related to records management Collaborate with Service Providers and CROs on TMF management including reviewing process, ensuring TMF completeness and managing the transfer of TMF records as needed. Represent the TMF team in audits and inspections for TMF related requests and questions. Lead the implementation of the eTMF and provide users training as needed. Conducts TMF facilities planning by reviewing short- and long-term resource and space requirements to identify and evaluate possible options for on and off-site locations. Manages direct reports and establishes goals and objectives to support the overall goals of the company.

SUPERVISORY RESPONSIBILITIES: This role will supervise employees.

EDUCATION/EXPERIENCE/SKILLS: Education: BS/BA in related discipline and 12 years of related experience; or, equivalent combination of education and experience

Experience: 16+ years' experience working in a pharmaceutical or other highly-regulated corporate environment, with significant, and increasingly independent, interaction with the various functional units of the corporation to design and develop record-keeping systems, policies and procedures 12 years' experience working in the Records Management field, including 5+ years’ 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 Seven years of people management experience with demonstrated experience in motivating teams, setting up goals, providing leadership and guidance as needed. 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 experience in Trial Master File requirements and set up. Advanced experience in the DIA Reference Model. A firm understanding of the clinical development lifecycle and the technologies associated with the activation and management of clinical trials and study sites. Strong understanding of study and site management and overall trial planning and execution. Strong knowledge of global regulatory requirements and ICH/GCP guidelines. Strong knowledge with electronic document management systems, document archival systems (eTMF) and CTMS system. Excellent attention to detail, strong critical thinking, and logical problem solving. Ability to proactively identify potential issues and formulate potential course(s) of action. Excellent organizational, time management and project management skills. Experience and comfort in working both independently and as part of a multifunctional team. Proven organizational skills and strong ability to prioritize workload. Commitment and ability to handle high workloads, demanding situations, and deadlines. Ability to interact and communicate effectively, both verbally and written, with colleagues and management, both within and outside clinical operations, including upper management, vendor personnel, and clinical investigators and site personnel. Able to carry out responsibilities with minimal to no supervision.

JOB COMPLEXITY: Applies judgement and professional expertise in new situations Independent team member performing highly technical or specialized work

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Additional Information

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.