Clinical Project Assistant
- Contract Type
Location: Brussels, Belgium
TalentSource Life Sciences, a division of CROMSOURCE, is currently seeking an enthusiastic Team Player, to join a Global, leading pharmaceutical company located in Brussels (1200), Belgium.
The Clinical Project Assistant will support a team working on the administrative follow-up of clinical studies. The Clinical Project Assistant provides administrative oversight to ensure the integrity and compliance to the Standard Operating Procedures (SOPs) and regulatory requirements of Investigator Initiated Studies.
- Ensure that essential clinical study documentation within the country is managed in compliance with Good Clinical Practices (GCP) and appropriate Quality Standards.
- Ensure local clinical operations is effectively supported with respect to system maintenance/reporting, point of contact for dealing with external submissions/questions directly or via team (where applicable)
- Manage and oversee multiple customers (CDC, COM, business COTA)
- Provide essential clinical study documentation within the country of responsibility is managed in compliance with Good Clinical Practices (GCP) and appropriate Quality Standards.
- Support local clinical operations with respect to system maintenance/reporting, point of contact for dealing with external submissions/questions directly or via team (where applicable)
- To provide administrative support to the local clinical operations team.
- Clinical study document management:
- Maintain study (paper and electronic) Trial Master Files - create, track, file and process essential document and reports
- Archive in-house files and third party archiving for sites
- Prepare documentation for close out
- Support with preparation of presentations
- Run periodic reports
- Coordinate and set-up meetings, teleconferences, agenda, minutes, travel arrangements, …
- Librarian role
- Patient voucher management
- Manage study materials
- Support the organization of start-up meetings (registration of participants, obtaining Mdeon approval, flight booking, transparency, etc.)
- Fluent in English, French and Dutch, both orally and written
- Strong administrative and organizational background
- Good documentation practices
- GCP knowledge
- Some level of knowledge of clinical research activities
- Excellent computer skills with experience in a variety of software packages (eg. Microsoft office, Impact, etc.)
- Knowledge of medical terminology
- Availability to work full-time position
- Problem solving skills
- Detail-oriented with strong emphasis on accuracy
- Be able to effectively communicate
- Strong organizational skills
- Detail-oriented working style with strong emphasis on accuracy and excellent communication skills
- Problem solving skills
Benefits working for TalentSource:
- Dedicated Line Manager
- Monthly meetings with line manager
- Employee satisfaction survey - your feedback is important for continuous improvement
- Annual appraisals development planning
- Yearly team event
- New Year's diner
- Group and hospitalization insurance
- Electronic meal vouchers
- Internet reimbursement
If you want to be considered for this exciting role, please apply directly@ https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00001440
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: Clinical Trial Assistant, CTA, Clinical Studies, Project Assistant, Being responsible for your own projects, Outsourcing, Pharma
Clinical Project Assistant, Clinical Trial Assistant, clinical trials