Country Operations Lead
3 dagen geleden
Pfizer is seeking a highly skilled Clinical Study Operations Lead to join our medical team. As a key member of our organization, you will be responsible for managing clinical studies, leveraging your project management skills to plan, direct, create, and communicate timelines. Your expertise will ensure that clinical studies are completed within time, budget, and scope.
Main Responsibilities- Provide guidance, lead/co-lead projects, manage own time to meet objectives, and plan resource requirements for projects across the division.
- Oversee and support study start-up activities at the country level, including review of key documents and providing support to address regulatory and/or ethics committee questions. Forecast and manage the Clinical Trial Budget.
- Approve and oversee drug supply management and manage the flow of drug supply to the sites.
- Share and escalate plan deviations to Clinical Project Manager and study team.
- Help to address Significant Quality Events or other quality issues at the patient and/or site level.
- Lead the data integrity and data quality activities for assigned protocols.
- Provide regional and cross-regional insights on study-site performance and trends to/from the study team.
We are looking for a candidate with a Bachelor's Degree and 5+ years of experience in the research and development of the pharmaceutical industry. You should have demonstrated project management/leadership experience, knowledge of project management discipline and its application to vaccine development, and country-level cultural awareness and strong interpersonal skills. Excellent communication skills in English and Dutch are required.
Nice-to-Have qualifications include a Master's degree and experience in early drug development.
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