An exciting opportunity has arisen for a TMF Manager to be responsible for all Clinical Operations. You will be expecting to work collaboratively with colleagues, external partners to contribute to effective eTMF Management.
- Oversight and management of end-to-end activities to ensure that all OBG study eTMFs are of the highest quality, audit & inspection ready and meet all applicable regulations and guidelines
- Active engagement and communication with Eisai functions and CRO stakeholders to ensure awareness of requirements, interpret metrics and drive timely TMF management
- Collaboration and liaison with Eisai's central TMF Management function on TMF business processes, including continuous improvement activities, training and metrics
Skills and Requirements
- Education to B.Sc. level or equivalent
- Demonstrated experience in the pharmaceutical industry, in Document Management, TMF Management or Clinical Development/Operations, with in-depth knowledge and experience of eTMF process and clinical documentation
- Proven experience with Electronic Clinical Document Management and eTMF systems and knowledge of eTMF requirements and technologies to support document collection and archiving
- Experience in interpreting and communicating KPI metrics and eTMF system reports for study team members and functional leadership
- Must possess excellent organizational and time management skills
- Ability to work both independently and as part of a team within a matrix environment
- Must have strong analytical and problem-solving skills
- Proficient in the use of information technology, especially eTMF and Electronic Document Management systems
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.