Summary

The Clinical Operations Specialist works with the Clinical Trial Team to ensure successful study conduct in collaboration with customer, other Line Functions and third-party vendors. You will be responsible for logistical aspects, vendor coordination and contribute to budget management of assigned clinical studies.

About the Role

Key Responsibilities:

• Evaluation of investigators fees (country level budget/Grant Plan) estimates per country.
• Negotiation of investigators fees and country related study costs; and supporting Clinical Project Manager (CPM) ensuring accurate planning, tracking and reporting of study budget.
• Set-up and coordination of third-party vendors (i.e. central lab, investigators' meeting organization) and monitoring partner, ensuring all information, documentation and material in place for study start.
• Effective and smooth workflow between study participants (i.e. third-party vendors and monitoring partner).
• Follow-up with vendors and monitoring partners on day to day operations (recruitment reports, delivery of study kits...)
• The set-up and maintenance of studies in Clinical Trial Management Systems (CTMS), ensuring all key documents are present and filed as appropriate in Trial Master File (TMF)
• Ensuring availability of study material for monitoring partner/sites

• Life Science degree or equivalent
• 3+ years' operational experience of clinical study execution in a pharmaceutical company or contract research organization
• Strong technical and organizational skills, details oriented, thorough knowledge of Good Clinical practice and presentation and tact skills
• Consistent track record to establish effective working relationship in a matrix and multicultural environment and willingness to act accountably in project/study management
• Strong customer focused mentality and proficient English (oral and written)