TMF Manager job in Hatfield, England

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Job type: Permanent

Discipline: VP/Head of Clinical Operations

Location: United Kingdom

This vacancy has now expired. Please see similar roles below...

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.

Job Responsibilities

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

To Apply

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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Salary

Highly Competitive

Location:

City of London, England

Are you looking to make an impact with your innovation? Proclinical is working with a dedicated pharmaceutical company to recruit for a Manager of Clinical Operations.