Description
Clinical Operations Manager- Contract
Contract- 12 month- Switzerland- Basel- Biopharmeceutical- clinical Operations- Phase III- Infectious diseases- oncology- pneumonia- trials- budgets- ICH-GCP- SOPs- regulatory authorities- monitoring- tracking
The opportunity has become available for two Clinical Operations Managers to join a reputable Swiss Biopharmaceutical company at their office in Basel, Switzerland. The company have new projects they are working on focusing on Phase III clinical studies.
The company focuses on the development of innovative antibiotics, antifungals and oncology drugs, targeting the medical challenge of resistance and non-response to current treatment options.
As a Clinical Operations Manager you will be responsible for:
*Supporting the Senior Clinical Operations Manager in the planning and conduct of global phase III trials.
*Performing assigned responsibilities to ensure high quality data, safety of patients and timely completion of the trials
*Support the planning, set-up and conduct of outsourced global Phase III trials
*Prepare trial budgets, forecasts, timelines and project plans
*Prepare contracts and budgets for assigned trials
*Supports CRO surveillance and management of other 3rd party vendors
*Review clinical study protocols and provide input
*Review and prepare other trial related documents
*Prepare clinical trial supplies projections
*Support the preparation of internal and external meetings, monitoring, workshops, investigators meetings
*Prepare and distribute ad hoc reports
*Prepares status reports
*Conduct co-monitoring visits
*Reviews monitoring visit reports
*Develops trackers
*Maintains knowledge of regulations, guidelines, policies and practices for conducting global clinical trials
*Participate in the periodic review and revision of departmental policies and SOPs to ensure compliance with corporate policies, ICH-GCP and regulatory authorities
*Follow departmental policies and procedures
An ideal Clinical Operations Manager will have:
*Clinical development experience working in the Pharmaceutical industry
*Experience in clinical operations/clinical trial management
*Experience in global phase III trials
*Monitoring experience
*Life Sciences Degree (M.S., PhD, MD desirable)
If you are interested in this opportunity and wish to discuss further details about the role please contact Sabrina Deo at +44 (0)121 616 3471.
Keywords:
Clinical development, clinical trials, clinical operations, phase, trials, studies, budget, vendor, pharmaceutical, CRO, protocols, monitoring, reports, ICH, GCP, trackers, regulatory, authorities, global, Switzerland, basel, contract, contractor, 12 month, life sciences, MD, PhD, biopharmaceutical, CRO
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