Clinical Affairs Manager executing clinical studies for a global healthcare company. Overseeing clinical trial management, stakeholder communication, and regulatory submissions.
Responsibilities
Execute clinical studies in accordance with IVD clinical guidelines
Participate in the management of budgets and timelines
Prepare clinical status updates for leadership
Manage direct reports and training for clinical trials
Communicate study information to stakeholders
Monitor third party performance and activities of clinical sites
Draft clinical documents for submission to regulatory agencies
Participate in meetings with regulatory agencies
Requirements
Bachelor’s degree in science, Biomedical Science or health-related field or equivalent education/experience
Typically requires 5 years’ experience in clinical research with at least 3 years of clinical trials execution role, preferably in an IVD company
Knowledge in Immunohematology and Immunoassay is preferred.
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