Senior Clinical Operations Manager (m/f)

REFERENZNUMMER:

359677/11

IHRE AUFGABEN:

-Direct the planning, set-up and conduct of paediatric trials (phase 1 to phase 3)
-Prepare trial budgets, forecasts, timelines, and project plans
-Negotiate contracts and budgets for assigned clinical trials
-Ensure close CRO surveillance and management of other third party vendors
-Review clinical study protocols and provide input
-Review and/or prepare other trial related documents (manuals, guidelines, visit reports, newsletters)
-Prepare clinical trial supplies projections and ensure the availability of a supply chain during the whole conduct of the trial
-Prepare and lead internal and external kick-off meetings, monitoring workshops and investigators meetings
-Supervise training programs to assure consistency and compliance in conduct and monitoring of clinical trials
-Participate in internal/external audits
-Participate in dissemination of clinical information to the core team members, as appropriate

IHRE QUALIFIKATIONEN:

-An advanced academic degree (M.S., PhD, PharmD, or MD) is preferred, a minimum academic degree in Life Sciences, Pharmacy or Medicine is required
-Profound experience in clinical development within the pharmaceutical industry
-Very good experience in clinical operations/clinical trial management, especially in managing outsourced global phase 3 trials
-Monitoring experience; ICH and GCP are necessary
-Fluency in English oral and written, German and French are beneficial
-Excellent problem solving and team building skills as well as management skills
-Excellent communication and organizational skills

WEITERE QUALIFIKATIONEN:

Clinical project manager