Senior Clinical Trial Manager
Abata TherapeuticsFull Time
Senior (5 to 8 years)
Candidates should possess a Bachelor of Science degree in a scientific or health field and have previous experience in clinical research, preferably within CROs, Pharma, or academic/hospital settings. A strong understanding of ICH GCP, relevant regulations, and clinical research/regulatory/ethical requirements is necessary. Proficiency in English and MS Office Suite is also required, along with excellent organizational, multitasking, analytical, communication, and interpersonal skills.
The Senior Clinical Trial Coordinator will ensure studies adhere to GCP, SOPs, protocols, budgets, and timelines, collaborating with the Study Start-Up team to ensure quality and timely completion of start-up activities. This role involves overseeing and mentoring junior coordinators, managing ethical and regulatory submissions, contract negotiations, ISF preparation, TMF setup, and maintenance. Responsibilities also include training junior staff, maintaining relationships with Ethics Committees and Competent Authorities, assisting with site/vendor invoicing and management, preparing project reports, updating CTMS, tracking study-specific information, supporting CRA activities, assisting with document translation, and participating in meetings and audits.
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.