Location: Belgium - home or office based
Schedule: Full-time, permanent
CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Project Manager. You will manage clinical projects to ensure quality, budget and timelines are met, while working on projects from our varied client base, ranging from small to mid-sized pharma, biotech and medical device companies.
Join our team and help us deliver clinical trials that will improve patients' lives.
Main Job Tasks and Responsibilities:
- Manage and coordinate assigned clinical projects
- Manage all project specific services required by the Sponsor (central lab exams, drug shipments, document shipments, etc.)
- Manage the correct development of the clinical project, interacting with the Sponsor and the Investigators and properly coordinating the project team members
- Keep professionally abreast of all scientific, regulatory and operational aspects relevant to the clinical projects assigned
- Demonstrate knowledge and follow appropriate trainings in the application process for clinical studies, in force in the courtry(ies) of work. Provide updates on the topic when needed.
- May act as Technical Specialist supervising the projects within specific therapeutic/technical areas
- Assure the proper timelines of the assigned projects
- Manage the budget of the project
- Monitor the workload and the performance of the project team
- Plan and monitor the tasks of the team in the specific areas
- Coordinate the Clinical Research Associates and Clinical Monitors activities, ensuring compliance with ICH-GCP guidelines and applicable laws and regulations
- Collaborate with the Clinical Trial Administrators and Clinical Research Associates in terms of local authorities approval activities
- Collaborates with the Clinical Trial Administrators in archiving activities
- Collaborate, in the overall management of the project, with the assigned Biometrics team and with all other project team members involved in the delivery of specific activities (such as Safety, Regulatory, etc.)
- Assist the Medical Monitor in preparing protocols, Case Report Forms (CRFs) and final Clinical Study Reports (CSRs)
- Deliver project specific trainings
- Organise and participates in Monitor's and Investigator's Meetings
- Organise and/or take part in the periodic project update meetings
- Provide project updates to the Sponsor, the Senior Project Manager and/or Project Director/Leader
- Inform the Project Director/Leader about any issues
- Perform co-monitoring visits for the assigned clinical projects, if necessary
- Carry out the monitoring of the sites for the assigned projects, when requested and if applicable
- Act as tutor for Project Coordinators
- May act as Feasibility Associate after appropriate and documented training
- Maintain contact with the Sponsor to verify the consistency with contract requirements and Sponsor satisfaction
- Prepare the SOPs relating to clinical research activities in collaboration with the Quality System Unit
- Collaborate in complying and enforcing Company procedures
Education and Experience:
- University Degree in scientific, medical or paramedical disciplines
- Proven experience as a Clinical Project/Study Manager or similar in the CRO/Pharmaceutical industry
- Experience with submissions and preparation of study documentation
- Excellent knowledge of clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements
- Advanced in English and local language(s)
- Proficiency in Microsoft Office (e.g. Word, Excel, Outlook)
- Willingness to travel
- Group and hospitalisation insurance
- Electronic meal vouchers
- Internet reimbursement
- Excellent work-life balance
- Full performance and development process with end of year reviews
- Team events and end of year party
- Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally
- Employee satisfaction survey - your feedback is important for continuous improvement
The Application Process
Once you have submitted your CV, you will receive an acknowledgement email. If you have the requirements we need, you will be invited for phone interview as the first step.
Who will you be working for?
CROMSOURCE is a family owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.
Our Company Ethos
Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE 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 the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our below industry average turnover rates.
CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.
Key words: Clinical Project Manager, Project Manager, CPM, PM, Study Manager, Clinical Study Manager, Clinical Trial Manager, CSM, CTM, SM, Submissions, Ethics, Contract Research Organisation, CRO
Clinical Project Manager