Covance is looking for an experienced home-based CRA Manager to lead a team of 12 CRAs across France.
Successful applicants will ideally have between 3-10 years of previous CRA management experience of CRAs and will be based in France. We are hoping to find applicants in the Paris or North West region of France but may consider other locations.
Has GCP Oversight of direct reports by ensuring GCP training is executed, understood and implemented
Identify and escalate GCP issues identified through regular interactionswith direct reports and conduct of Quality Control Visits
Ensures training record compliance with training matrix and ensure
Hold clinical operations and co source saff accountable for GCP issue escaliation to the management team, the sponsor and QA, as appropriate.
Coach assigned staff to own effective investigator relations and investigator oversigh at the local level.
Communicate status of assigned workload for metric reporting
Perform weekly review of direct report biliable hours and associated utilization per the quaterly and annual budget plan, and escalation of outliers to management team for mitigation.
Escalates availaleworkload jours, in contact of project allocation, supply and demand, to management team.
Engage in Resource management activities for direct reports.
Schedule Quality Control visits to ensure costs are in alignment with regional budget.
University/college degree - life sciences preferred or certification in a related allied health profession from an appropriately accreditedinstitution.
In lieu of this required educational backgroung the following relevant work history may be considered :
Minimum of 3 years supervisory experience in a health care or clinical reserach srtting and
Minimum of seven years relevant clinical research expericne in a pharmaceutical company/CRO
Preferred : Masters or other advanced degree.
Relevant clinical research experience in a pharmaceutical company or CRO
Individual is proficient with on site monitoring activities
Minimum of 5 years relevant clinical research experience in a pharmaceutical company/CRO
Thorough knowledge of drug development process
Thorough knowledge ofrelevant SOPs, ICH, and GCP guidelines
Relevant supervisory experience
Minimum of 1year as a line manager or project manager required
Demonstrated abilityto lead by exampleand to encourage teammembers to seeks solutions.
Proven interpersonal skills.
Advanced oral, written and presentation skills
Advances planning and organizational skills.