Serve as primary contact for project-related matters, managing client expectations to ensure satisfaction with PrimeVigilance services.
Prepare project scope and objectives based on signed agreements, and plan activities including deadlines and interim milestones.
Report to clients and PrimeVigilance management, including monthly reports for invoicing basis.
PrimeVigilance is a global pharmacovigilance specialist helping clients navigate complex regulations while keeping patient safety at the center of every decision. The company operates across Europe, North America, South America, Asia, and Australia, fostering a culture built on kindness, flexibility, growth, and belonging.
Responsible for preparing and submitting clinical trial applications to Competent Authorities and Ethics Committees, ensuring compliance with local and international regulations.
Manages site start-up activities including essential document collection, informed consent form review, and coordination with investigators and contracts.
Acts as a subject matter expert for regulatory submissions and may support process improvement, training, and mentoring.
Precision for Medicine is a clinical research organization (CRO) that integrates clinical trial execution with deep scientific knowledge, laboratory expertise, and advanced data sciences to improve the speed and success rate of bringing therapies to patients, with a focus on Oncology and Rare Disease. It is a growing company with a culture of innovation and collaboration.
Collaborate with headquarters and internal teams to communicate US reprocessing and infection control needs.
Develop and support validation programs for endoscope reprocessing, working with independent labs and Fujifilm Tokyo.
Serve as the primary subject matter expert and educator on reprocessing and infection control for the Endoscopy Division.
FUJIFILM Healthcare Americas Corporation provides cutting-edge healthcare solutions including diagnostic imaging, endoscopic and surgical imaging, and in-vitro diagnostics. Fujifilm globally employs over 70,000 people and is guided by a purpose of giving the world more smiles.
Lead the study start-up process, developing strategy and coordinating regulatory deliverables to meet targets.
Serve as primary contact for start-up activities, prepare and review regulatory documents, and ensure compliance with ICH-GCP and regulations.
Manage essential document collection, site correspondence, contract negotiations, and support team training and budget monitoring.
Ergomed is a mid-sized contract research organization specializing in oncology and rare disease. The company has a global presence with operations in Europe, North America, and Asia, and emphasizes employee well-being, work-life balance, and career development.