Clinical Research Manager
hace 1 día
The Clinical Research Manager is a key role within MSD, responsible for the end-to-end performance and project management of assigned protocols in a country. This position is accountable for ensuring compliance with ICH/GCP and country regulations, Company policies and procedures, quality standards, and adverse event reporting requirements.
About the RoleThis role requires strong organizational skills, with the ability to plan, drive, and track execution and performance of deliverables/timelines/results. The successful candidate will be responsible for main points of contact (POC) for assigned protocols, linking Country Operations and clinical trial teams (CTT). They will also be accountable for performance for assigned protocols in a country.
- Key responsibilities include:
- Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).
- Responsible for project management of the assigned studies: pro-actively plans, drives, and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution, and close out.
- Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Company policies and procedures, quality standards, and adverse event reporting requirements internally and externally.
- Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed.
- Performs Quality control visits as required.
- Lets local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration (including the CTC, CRAs, and COM).
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Clinical Research Coordinator
hace 4 días
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Clinical Research Coordinator
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Clinical Research Coordinator
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Clinical Research Coordinator
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Global Clinical Research Coordinator
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