Associate Director, Trial Master File
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.
- BS/BA in related discipline and 10 years of related experience; or, equivalent combination of education and experience
- 14+ years' experience working in a pharmaceutical
- 10 years' experience working in the Records Management field, including 4+ 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
- Five 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.
- 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.
Equal Opportunity Employer/Veterans/Disabled
To read our Candidate Privacy Information Statement, which explains how we will use your information, please
The Company will consider qualified applicants with arrest and conviction records