Clinical Program Operations Manager, Therapeutics & Innovations
NateraSalary not specified
- Full Time
- Senior (5 to 8 years)
Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, Clinical ResearchIndustries
Requirements
Candidates should possess a Bachelor’s degree in a scientific discipline, such as Biology, Chemistry, or Nursing, and have a minimum of 5 years of experience as a Clinical Research Associate, with demonstrated expertise in Oncology clinical trials. Strong knowledge of ICH GCP guidelines, FDA regulations, and relevant clinical trial standards is essential, along with experience in Romania.
Responsibilities
The Senior Clinical Research Associate will provide guidance and oversight to the CRA team, ensuring adherence to project scope, SOPs, and timelines. They will conduct monitoring visits, review monitoring reports, and address site-related issues, coordinating with cross-functional departments to facilitate study execution. The Sr CRA will also manage study budgets, prepare monitoring visit reports, ensure protocol and GCP compliance, conduct investigational product accountability, and maintain regular contact with study sites to assess patient accrual and respond to sponsor requests.
Skills
Clinical Monitoring
Site Management
Regulatory Compliance
Study Coordination
Monitoring Visit Review
Team Guidance
Study Protocols
Ethics Documentation
Budget Management
Abarca Health
Pharmacy Benefit Management services provider
About Abarca Health
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.
Key Metrics
Aventura, FloridaHeadquarters
2005Year Founded
VENTURE_UNKNOWNCompany Stage
HealthcareIndustries
501-1,000Employees