Clinical Study Leader
AIXIAL is an International Contract Research Organization (CRO), a member of the ALTEN Group, providing complex services in clinical trials (phase I-IV) and non-interventional studies. Our offices are located in France, Switzerland, Belgium, Germany and Czech Republic.
We are currently looking for an experienced Clinical Trial Leader to drive all assigned clinical operations’ activities related to the clinical studies from protocol summary, study site selection and regulatory activation process what includes (but not limited to):
- Assist the CSL/CPL in the CRO selection process by reviewing relevant documentation, for example RFP documents, questions and answers…
- Verify that all 3rd party vendors that have been contracted directly by the sponsor have been audited/qualified. Collaborate with the QA department to make sure all approvals are in place prior to the study start
- Calculate and order the IMP/non IMP for the clinical study in close collaboration with the CSL and the CMC group.
- Prepare directly or coordinate the preparation of the project plan, the study protocol, the synopsis, the (e)CRF, the study procedure, ICF..
- Assist with the development of the safety monitoring plan / safety tables prepared by the medical monitor and the QPPV responsible.
- Assist with the organization of the Investigator/CRA meeting by reviewing presentations or selecting meeting venues
- Coordinate activities (if delegated by the CSL/CPL) performed by external partners (CRO, central lab, IWRS provider, …).
- Closely monitor all work performed by the external partners to ensure the quality of the service with respect to the mutually agreed timelines and budget.
- Assist with the preparation of the Site Initiation Visits. Participate to the site staff training to the use of the investigational product, to the data collection and to the study specific procedures.
- Coordinate with the internal and external partners the preparation and review of the Clinical Study Report
- Provide all study related documentation to the CTA in a timely manner to allow the CTA to maintain the Trial Master File throughout the entire study duration and to be ‘inspection ready’.
- Demonstrate leadership and maintain a good relationship with all internal and external partners.
- Work closely together with the CSL/CPL to ensure a smooth continuation of the studies
- Clinical project management experience (ideally in the leading position)
- Previous experience as CRA for a CRO or sponsor is an advantage
- Health/Life science background
- ENG required, French is a plus