- Contract Type
Trial Master File Specialist
Location: Leuven, Belgium
Start-date: As soon as possible
TalentSource Life Sciences, a division of CROMSOURCE, is currently seeking an experienced Trial Master File Specialist (TMF Specialist), to join an innovating company, focused on developing and commercializing innovative ophthalmic and oncology medicines, located in Leuven, Belgium.
Scope of the function:
This is a specialist role in managing the Trial Master File, where The TMF Specialist is responsible for the overall quality, accuracy, appropriateness, and completeness review of study files. This position is highly visible and interactive with cross-functional teams and external vendors and plays a critical role in both paper and electronic TMF document management activities, in accordance with ICH-GCP procedures.
· Provide qualified GCP Records Management support for Trial Master File (TMF) Records.
· Ensure the management and oversight of TMF activities for paper and electronic documents to ensure delivery of a high quality TMF
· Serve as a TMF contact for documentation to the project team, and cross functional departments to ensure high quality TMF deliverables are met on time.
· Follow applicable SOP's to ensure completeness & accuracy of the TMF, as well as, records management tasks, policies, and procedures.
· Obtain and maintain essential documentation in compliance with ICH-GCP.
· Fluent knowledge of spoken and written English.
· Vast knowledge of applicable clinical research regulatory requirements/global international records standards to the area of expertise (Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
· Previous experience of conducting file reviews of Trial Master Files is essential.
· Good knowledge of relevant local regulations.
· Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
· Ability to deliver quality according to the requested standards.
· Ability to work in an environment of remote collaborations.
· Excellent written and verbal communication skills, negotiation, collaboration and interpersonal skills.
· Good analytical and problem solving skills.
· Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
- A competitive salary package and benefits
- A dynamic and enthusiastic work environment
- A job in which you can show your strengths and experience
- Dedicated Line Manager - 1-2-1 support
- Coaching meetings/Monthly Calls - we care for your wellbeing
- Employee satisfaction survey - your feedback is important for continuous improvement
- End year appraisals and development planning
- Yearly team event
- New Year's diner
- Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally
If you have the experience needed for this position, please don't hesitate applying via the following link https://www.talentsourcelifesciences.com/find-a-job/
Why TalentSource Life Sciences/CROMSOURCE:
Cromsource is a family-owned, high quality ISO-certified international provider of outsourced services to the pharmaceutical, biotechnology and medical device industries. Since 1994, we have been supporting our clients with outstanding clinical research and staffing solutions services. TalentSource Life Sciences is a fully dedicated flexible resourcing unit within CROMSOURCE and the successful growth has been achieved by putting high quality and client focus at the heart of everything we do.
Our employees are the most valuable company asset and we value resources and ensure they work in a friendly, family environment and develop their skills and talents. Human Resources is the fulcrum around which all activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel clear tools to manage both internal and client processes with the same methodology.
Our approach is to equally value our clients and our own people. We know that we are not simply providing 'staff' or 'resources'. We are providing expert people. Highly talented, well trained, motivated people who make a positive difference to the work of our clients every day. Together we help our clients succeed in their work developing medicines and medical devices for patients around the world. Our large management team consists of a people with an extended experience within pharma and a high level of market knowledge. We our open, friendly and approachable and aim to support you through the recruitment process every step of the way.
As this position is client-facing, the successful candidates must be confident and be able to drive the role and themselves and to work autonomously in close liaison with a line manager at TalentSource, who will provide you with mentoring and guidance.
To ensure the success of our clients, our team of international professionals is focused on continuous improvement. We invest in our employees by providing the coaching and training necessary to deliver high quality services for our clients.
Every day we strive to create an environment in which all employees can contribute to their full potential and at the same time allow the company to develop and grow with them. With CROMSOURCE you will be able to participate in exciting projects and achieve your professional goals.
Keywords: trial master file, TMF, electronic TMF, e-TMF, Clinical Archiving, ICH-GCP, Specialist, If it is not documented, it did not happen, Temporary Assignment
TMF Associate, eTMF, TMF