Senior Clinical Operations Manager

Company : Basilea Pharmaceutica Ltd, Allschwil

Job Type : Full Time

Allschwil

Job Description - Senior Clinical Operations Manager

....a highly motivated Senior Clinical Operations Manager for our Development department.

Lead the planning, set-up and conduct of clinical trials (phase I to III)
Preparing trial budgets, forecasts, recruitment projections and project plans
Negotiating contracts and budgets for assigned clinical trials in cooperation with Finance Department and Project management
Management and surveillance of CRO(s) and third party vendors
Leading the internal study team and working with relevant functions to deliver the trial within timelines, budget and with high quality
Reviewing clinical study protocols from operational standpoint and providing input as well preparing trial related documents (manuals, guidelines, visit reports, newsletters)
Performing UATs
Planning and leading project meetings, training workshops and investigators meetings
Supervising training of study team members to assure consistency and compliance in conduct and monitoring of clinical trials
Preparing and distribution regular and ad hoc reports, summaries, or analyses as required as well status reports for assigned clinical trials
Conducting co-monitoring and oversight visits and participation in internal/external audits

Minimum 9 years’ experience in clinical trials phase I – III and and minimum 2 years as Clinical Trial Manager
Experience working hands-on on phase I, II and III studies in cross-functional environment at a CRO or study sponsor
Strong understanding of various functions’ contributions in the set-up and conduct of clinical trials
Solid understanding of common clinical trial systems (EDC, IRT, eTMF, CTMS, etc.)
Sound knowledge of ICH-GCP and clinical trial regulations across regions and countries
Excellent communication skills across all levels, internally, externally, cross-functionally and in a highly collaborative matrix environment
Excellent team and problem solving skills in international and cross-functional environment
Fluent in English, spoken and written, any other language is considered beneficial
Willingness to travel

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Senior Clinical Operations Manager

Job Description - Senior Clinical Operations Manager

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