Global Clinical Trials Operations Manager

• Participates in the review of the protocol.
• Collaborates with the clinical team to identify relevant vendors and consultants.
• Establishes the study budget with assistance from finance and in collaboration with the study team.
• Prepares recruitment projection and selects countries and sites with assistance from the CRO and in collaboration with the study team.
• Reviews and approves protocol related (ICF/Monitoring/Quality Plans/CRF's/e-CRF's) documents in collaboration with the study team.
• Reviews and approves contracts direct and indirect fees of final proposals.
• Manages the study team meetings and actively interact with key interfaces such as Medical, Regulatory Affairs, Biometrics, Device etc.
• Manages the meetings with the CRO at the study level.
• Oversees the CRO and applicable vendors.
• Ensures all study related manuals are completed, signed and revised as needed.
• Manages the study budget and ensures accurate and timely payment of invoices to the CRO and vendors.
• Plans and manages investigators and Kick-off meetings in close colaboration with the CRO.
• Ensures that training and applicable Sponsor’s information and/or materials are provided to all CRO/vendor personnel participating in the coduct of the study.
• In case of premature study termination or temporary suspension, leads the appropriate follow-up, ensures the trial termination plan and distribution to the CRO/vendor is accomplished inline with the applicable Sponsor’s SOP and regulatory and public relations requirements.
• Ensures a summary of the CSR is distributed to the relevant parties.
• Provides regular updates that include progress on recruitment, data collection, quality, and spend vs. budget information.
• Participates in the review, development and revision of departmental SOPs.
• Leads or participates in training needed for the CRO/Vendor.
• Ensures compliance with Quality standards (SOPs, GCP, etc.).
• Develops in-depth knowledge in relevant indications and clinical trials methodology.
• Any other task assigned by direct manager.
Education and Knowledge Requirements:
• Undergraduate/BSc degree or higher inapplicable discipline and 5-7 Yrs of related experience
• At least 4 years of experience pharmaceutical industry or clinical research site based experience
• Global trial experience is a must
• Monitoring experience preferred
• Knowledge of ICH-GCP guidelines
• Must be able to travel with overnight stays, as necessary, travel up to 10%
• Computer literate