Achieva are currently looking for a Clinical Operations Manager to work on site near Basel, Switzerland. This is a 12 months contract opportunity.
Job Responsibilities
The Clinical Operations Manager is driving the development of the operational trial related documents and procedures, as well as setting-up the ESPs and supervising the deliverables of all ESP related activities, from specifications to close-out. For large Phase III or complicated trials, several Clinical Operations Managers might be assigned to a trial for the management of ESPs.
- Manage the operational trial related activities in close collaboration with other functions, such as: site initiations, site closures, import/export licences for materials and IMP, eTMF set-up and maintenance, contracts execution and invoices, submissions to Health Authorities, submissions to Ethics Committees/Institutional Review Boards (ECs/IRBs), timely completion of electronic Case Report Forms (eCRFs), Source Data verification (SDV) progress and query responses timelines
- Manage the selection of ESPs in collaboration with other functions
- Lead the development of ESP specifications, testing and implementation in collaboration with other functions, and ensure appropriate quality control of deliverables
Candidate?s Requirements
- Bachelor of Science degree or equivalent University degree in life sciences or healthcare
- 4 years of experience in managing operational aspects of Phase II and Phase III trials and executing a wide range of clinical trial activities from study start up to clinical study report
- Experience in working in global cross-functional (matrix) and multicultural teams
- Experience in selecting and managing External Service Providers , including performance assessments and finance management
- Previous experience working with electronic data capture, electronic Trial Master File (eTMF), and Clinical Trial Management Systems (CTMS)
- Strong interpersonal, communication (written and verbal), collaboration and organizational skills
- Self-motivated and able to work independently and proactively
- Goal-oriented, able to effectively prioritize and execute tasks in a high-pressure environment
For more Information, please contact Fandi Hatib +441727 817600 and email fhatib@achieva.co.uk
- Agency: Achieva Group Limited
- Reference: FH-39
Website: Achieva Group Limited
- Posted: 15th June 2022
- Expires: 13th July 2022
