Senior Clinical Operations Specialist
hace 22 horas
The Senior Clinical Operations Specialist is responsible for the overall performance and project management of assigned protocols in a country. This includes:
- Ensuring compliance with ICH/GCP and country regulations, Company policies and procedures, quality standards, and adverse event reporting requirements.
- Leading local study teams to high performance by training in the protocol other local roles, collaborating with and supporting CRAs as protocol expert, and coordinating activities across the different local country roles.
- Reviewing Monitoring Visits Reports and escalating performance issues and training needs to CRA manager and/or functional vendor and internal management as needed.
- Performing Quality control visits as required.
- Managing resource allocation, processes (and controls), productivity, quality, and project delivery.
To be successful in this role, you will require:
- Strong leadership skills that enable and drive alignment with the goals, purpose, and mission of MSD Research Labs, Global Clinical Development (GCD), and GCTO.
- Ability to identify problems, conflicts, and opportunities early and lead, analyse, and prepare mitigation plans and drive conflict resolution.
- Strong scientific and clinical research knowledge and understanding of local regulatory environments.
- Effective communication and building professional relationships with investigators and other stakeholders.
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