Clinical Trial Lead / Менеджер по клиническим исследованиям

We are currently looking for a highly qualified and experienced professional for a project role (1,5 years) in clinical trial to fill in the position of Clinical Trial Lead (CTL). We expect CTL to provide efficient oversight to CRO for assigned trials in Russia under branded portfolio. CTL will ensure country level trial deliverables are met in timely manner and study success. CTL is expected to adhere to required procedures and quality in compliance with Sun SOP’s, Processes, ICH-GCP and local regulations.

Обязанности:

• Act as key country Sponsor contact point for CRO and manage overall CRO communications
• Review and Approve CV’s of CRO Monitors and Project Managers. Ensure CRO staff are trained on required SOP’s, Protocol and trial specific systems before they start working on trial specific activities
• Provide close oversight for CRO driven activities in planned manner and periodically as per below listed aspects (but not limited to):

• Collaboration and communication closely with SPIL cross-functional units (Regional Clinical Operations team (RCO) team in India, Clinical sciences, Quality team, Data Management, and other stakeholders to ensure proper execution and conduct the study effectively.
• Maintain Sponsor TMF for filing of trial documents generated by SPIL and important communications, decisions, vendor data, etc.
• Perform site oversight visits periodically to perform source data review and source data verification of sample data to ensure compliance with protocol, local regulation, ICH-GCP, applicable SOP’s. Site oversight visits to be performed to cover all sites at-least once of the respective study and additional visits as risk based and agreed internally with RCO team. Ensure oversight activities are documented and observations are reported immediately to CRO Monitor and other staff
• Ensuring availability of trial supplies like ancillary supplies, e-diaries, recruitment and retention materials, Lab kits, others
• Track recruitment / retention strategies at study and site level, ensure recruitment risks are communicated pro-actively to management and actions are planned in a timely manner
• Ensure overall trial conduct in the country is as per quality standards, quality risks are timely escalated and mitigations are planned to prevent re-occurrence
• Facilitate site audits and Inspections along with CRO staff
• Other tasks as assigned related to study deliverables

• Minimum graduation in biological sciences, Pharmacy and allied domains. Added qualifications will be preferred

• Overall minimum 8-10 years of experience, out of which at-least 03-04 years of trial site monitoring experience for Phase III/II Clinical trials
• At-least 02 years of experience with-in clinical project management for Phase III/II trials
• Experience in dermatology will be an advantage
• Well versed with English – verbal and written communication skills (B2 and above)
• Open to frequent travel

• Competitive salary
• Hybrid
• Part-time (20 hours a week)

• Temporary employment contract (1-1,5 years)