Clinical Project Manager
Clairo- Full Time
- Junior (1 to 2 years)
Candidates should possess a Bachelor's degree in a relevant field such as Healthcare Administration, Business Administration, or a related discipline, and possess at least 8 years of project management experience, with a minimum of 5 years specifically within clinical research or pharmaceutical development. Strong knowledge of ICH GCP guidelines, FDA regulations, and clinical trial processes is essential, along with demonstrated experience managing complex clinical studies and cross-functional teams.
The Senior Clinical Project Manager will manage clinical research studies to ensure adherence to approved scopes of work, budgets, and timelines, serving as the primary contact for sponsors and overseeing all clinical study functions including investigational supply, IWRS/IXRS, data management, and pharmacovigilance. They will supervise and support the Clinical Operations team, create and review clinical study documents, drive teamwork and communication, ensure accuracy of reports, manage subject accrual and retention, coordinate TMF management, and prepare for audits and inspections. Furthermore, the role involves presenting study status updates, assisting with training, and performing additional duties as assigned.
Pharmacy Benefit Management services provider
Abarca Health provides Pharmacy Benefit Management (PBM) services, focusing on flexible and user-friendly solutions for health plans, employers, and government programs like Medicare and Medicaid. Its main product, the Darwin platform, allows clients to quickly implement and modify benefit designs while ensuring compliance with regulations. Abarca Health manages over $5.3 billion in drug spend and processes 100 million prescription claims annually, offering additional services like home delivery for prescriptions. The company's goal is to deliver exceptional service and innovative solutions in the PBM market.