Senior Project Manager
Abarca HealthSalary not specified
- Full Time
- Senior (5 to 8 years), Junior (1 to 2 years)
Thermo Fisher Scientific
Senior, Clinical Trial Manager, CTM - FSP (North America, EAST COAST)
Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, Biotechnology, Clinical ResearchIndustries
Requirements
Candidates should possess a Bachelor's degree in a relevant scientific or clinical discipline, and ideally hold a Master's degree. A minimum of 8 years of experience in clinical trial management, with at least 5 years specifically in a senior role, is required. Strong knowledge of GCP guidelines, clinical trial regulations (FDA, EMA), and relevant SOPs is essential. Demonstrated experience in coordinating clinical monitoring activities and managing CRO relationships is also necessary.
Responsibilities
The Senior Clinical Trial Manager will oversee the coordination and oversight of clinical monitoring activities, ensuring adherence to regulatory requirements and GCP guidelines. They will be responsible for supporting study start-up, managing CRO relationships, facilitating site visits, and monitoring study deliverables. The role involves collaborating with CPMs, preparing documentation, validating study documents, and providing guidance to internal CRAs. Additionally, the manager will participate in the RFP process, contribute to timelines and milestones, and support the Medical Affairs team as needed.
Skills
Clinical Monitoring
CRO Oversight
Site Management
Regulatory Compliance
GCP Guidelines
Study Start-up
Site Feasibility
Regulatory and Ethics Documentation
EDC Systems
CRAs Training
Thermo Fisher Scientific
Provides life sciences products and services
About Thermo Fisher Scientific
Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.
Waltham, MassachusettsHeadquarters
1956Year Founded
$17MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees