Clinical Development Lead, Transplant Expansion / New Indications
BiogenFull Time
Senior (5 to 8 years)
Candidates must possess a Bachelor's degree in a life sciences field, a Registered Nursing certification, or an equivalent qualification. A minimum of 2 years of experience as a clinical research monitor is required, along with a valid driver's license if applicable. Equivalencies combining education, training, and experience may be considered.
The CRA will conduct risk-based monitoring of investigator sites, applying root cause analysis to identify and correct compliance issues. Responsibilities include ensuring data accuracy through SDR, SDV, and CRF reviews, assessing investigational products, documenting observations, and escalating deficiencies. The role involves maintaining communication with sites, managing trial status updates, ensuring system updates, participating in investigator meetings, identifying potential investigators, initiating clinical trial sites, and ensuring trial close-out. The CRA will also verify essential document completeness, conduct file reviews, contribute to project teams, facilitate communication, respond to regulatory requirements, and complete administrative tasks.
Provides life sciences products and services
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.