We are seeking a highly skilled and motivated Clinical Operations Manager to join our client's dynamic team. In this role, you will be responsible for overseeing the operational aspects of Phase II and III clinical trials, ensuring compliance with protocols, and managing the selection and performance of External Service Providers (ESPs). The ideal candidate will have a strong background in life sciences or healthcare, proven experience in global and multicultural team environments, and excellent knowledge of ICH-GCP guidelines.
Experience and Knowledge
* Bachelor of Science or equivalent degree in life sciences or healthcare.
* Minimum 4 years of experience managing operational aspects of Phase II and III clinical trials from study start-up through clinical study report.
* Proven experience working in global, cross-functional, and multicultural teams.
* Skilled in selecting and managing External Service Providers (ESP), including performance and financial oversight.
* Proficient in electronic systems such as EDC, eTMF, and CTMS.
* Excellent knowledge of ICH-GCP guidelines.
* Fluent in English with strong awareness of cultural diversity.
* Position may require international travel.
Responsibilities and Tasks
* Develop operational trial documents and procedures; manage ESP set-up and delivery.
* Oversee clinical trial operations including site initiations/closures, material and IMP logistics, eTMF, contracts, submissions, eCRF completion, SDV progress, and query timelines.
* Collaborate with functions to select and manage ESPs and CROs, ensuring compliance with protocol and deliverables.
* Lead development of ESP specifications and conduct quality control of outputs.
* Report operational trial-level updates, including KPIs and issues, to the Clinical Trial Team.
* Resolve operational issues and serve as liaison for CRAs to maintain data quality.
* Contribute to Study Master File readiness and quality checks.
* Participate in Investigator Meetings, Site Selection Visits, and Site Initiation Visits as needed.
* Mentor team members and support additional project/trial activities as assigned.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Science
Industries
Pharmaceutical Manufacturing
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