Freelance Senior Clinical Operations Manager - Basel - 12 month contract

​RBW Consulting are proud to be partnered with one of the worlds leading Biotech's in their search for multiple Freelance Senior Clinical Operations Managers to be based out of Basel for a 12 month contract starting ASAP!

The Senior Clinical Operations Manager supervises all the operational trial related activities and the operations team assigned to the trial. The Senior Clinical Operations Manager is accountable for ensuring the delivery of global operational outputs in accordance with the trial timelines and quality standards.

• Job Title: Senior Clinical Operations Manager

• Work Location: Allschwil

• Country: Switzerland

• Schedule: Fulltime (100%)

• Desired start date: ASAP

• Duration: 12 months

• Contractor Rate: CHF 82.20

Duties

• Provide operational input to the project planning, trial plans and any activity affecting the operational performance and quality of the trial.

• Report all the operational aspects of the trial into the Clinical Trial Team (CTT) leader.

• Lead the operational planning and trial related activities in close collaboration with other functions.

• Supervise the operations team assigned to the trial, provide clear instructions and set priorities.

• Supervise resolution of operational issues in a proactive and timely fashion.

• Supervise the selection and management of External Service Providers (ESPs) and Clinical Research Organizations (CROs) and the development of trial-related operational documents.

• Manage the clinical trial supplies in close collaboration with Technical Operations: forecasting, ordering, distribution, import/export licenses.

• Oversee information on operational clinical trial level activities for reporting into the CTT (including critical issues and key performance indicators).

• Ensure adequate trial-specific training is provided to the assigned operations team and CRO/ESPs.

• Supervise the Study Master File (StMF) to ensure completeness and readiness for audit/inspection. Contribute by performing ongoing quality checks/review.

• Actively participate to Investigators meeting preparation and presentations, and to Site Selection Visits (SSVs) and Site Initiation Visits (SIVs), as necessary.

• Support business unit/departments in internal audit preparations and during audits, and ensure the follow-up of and resolution of audit findings related to operational activities.

• Perform line management of Clinical Operations Coordinators and/or Clinical Operations Managers when applicable: Supervise, lead, mentor and coach direct reports.

• Ensure continuous training needs are identified for career development of personnel.

• Review, approve invoices and expenses for direct reports.

• Perform yearly quality control (QC) of training binders.

• Assume responsibility for other project or trial-related duties as assigned.

Experience and Knowledge 

• 7 years of experience in managing operational aspects of complex Phase II and Phase III clinical trials and global teams.

• Experience in leading global cross-functional (matrix) and multicultural teams.

• Ability to represent Clinical Operations in high level Clinical Development meetings.

• Intensive experience in selecting and managing External Service Providers (ESP), including performance assessments and finance management.

• Previous experience working with electronic data capture, electronic Trial Master File (eTMF), and Clinical Trial Management Systems (CTMS).

• Excellent knowledge of ICH-GCP.

• Advanced computer skills (e.g., Microsoft Office, Word, Excel and Power Point)

• Excellent verbal and written communication skills in English; strong cultural knowledge of national diversities. 

Please apply here and Harry Henson will be in touch to discuss your application further.