Covance is recruiting for its FSP Unit a Clinical Operation Manager (M/W) dedicated to one of our client, a very well known pharmaceutical company.
This is a office based position in Paris area (92).
The Clinical Operation Manager will be responsible for execution and oversight of local operational clinical trial activities in a country for assigned protocols in compliance with ICH/GCP and country regulations.
FINANCIAL: Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA) Oversight and tracking of clinical research-related payments. Payment reconciliation at study close-out.
COUNTRY SUBMISSIONS & LOCAL LANGUAGE MATERIALS: Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols.
Development of local language materials including local language Informed Consents and translations. Works in partnership with IRB/IEC and Regulatory Authority in submission and approval-related interactions for assigned protocols.
MANAGEMENT & QUALITY OVERSIGHT: Responsible for managing country deliverables, timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in the country. Contributes to the development of local SOPs.
COLLABORATION: Works in close collaboration internally with GCTO country operations
LOCAL PROCESS OVERSIGHT / Investigational Product management : Oversight and coordination of local processes.
For more information on this career opportunity, please get directly in touch with Christelle Segabiot : firstname.lastname@example.org / +33 141 05 73 38