Our pharma client is looking for an enthusiastic Local Trial Manager to join the clinical team. Are you a seasoned clinical research professional with experience in CT submission and contract negotiation ? You're trilingual NL-FR-ENG and looking forward to building further on your experience and being part of a great team ? Then this may be for you !
Local Trial Manager (LTM)
LTM is nominated on country (OPU)y level and works within the Clinical Operations Division (ROPU). The LTM works in close collaboration with the COL (Clinical Operations Leader), Clinical Trial Manager (CTM) and the CRO-Clinical Research Associate (CRA) for the implementation and management of one or more clinical trial(s).
- The LTM will ensure timely execution of allocated responsibilities according to process, including but not limited to:
- Perform OPU and site feasibility/selection within the defined timelines by identifying (academic) networks, External Experts and top recruiting sites in close collaboration with Medical Affairs and the Clinical Operations Lead site selection
- Accountable for the start-up activities on local level ensuring that allocated trials are started within the defined timelines.
- Negotiation and finalization of study contracts in line with fair market value
- Preparation (and submission) of local study documents for approval to EC and CA in the required local language where applicable
- Accountable for set-up and management of trial budget on OPU level, including making updates based on financial reports in close collaboration with CTM
- Participate in appropriate study trial team meetings to report the status on start-up progress and align on recruitment strategies and action plans with the CRO-CRA, CTM, COL and Medical Affairs to ensure predefined study targets are met.
- Represents the client (ClinOps) in both internal and external communication and plays a site relation management role on OPU level during feasibility process and the entire duration of the trial.
- Ensures all tasks are carried out in accordance with respective applicable client SOPs, client Business Practices and regulatory requirements.
- All interactions and engagements are carried out with the highest ethical and professional standards and all work is accomplished with quality and in accordance with client Values.
- University Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.
- Previous experience in clinical research or equivalent is required.
- Experience required in CT submission and contract negotiation
- Trilingual FR/NL/ENG
- Fast learner
- Existing right to work in Europe required
- A balanced salary package based on your capabilities and experience
- Flexibility in term of homeworking (2 days/week on site is required)
- Open for Employees and Freelance