Senior Project Manager
Abarca HealthFull Time
Senior (5 to 8 years), Junior (1 to 2 years)
Bachelor's degree in Nursing or related Health Sciences (Physician's Assistant) or licensed RN is required. A minimum of 5 years of experience in clinical safety, clinical research monitoring, or pharmacovigilance is necessary, with at least 5 years specifically in clinical research monitoring or pharmacovigilance, or a combination thereof. Equivalency may be considered with a combination of appropriate education, training, and directly related experience.
Manages, coordinates, and evaluates medical projects, ensuring consistency, alignment, and compliance with internal processes and optimal performance throughout the project lifecycle. Represents the company in the medical research community and develops collaborative relationships with clients. Performs first-pass review of safety data, identifying trends, coding consistencies, and potential follow-up with investigator sites, resolving or escalating issues as appropriate. Reviews safety data for summation in safety review meetings and designated sections of aggregate reports. Functions independently as the Project Lead for medical monitoring services when SAE case processing is not contracted, managing project implementation, coordination, maintenance, and close-out. Serves as the primary point of contact for clinical project teams and may act as an alliance level lead on larger studies. Creates and maintains medical management plans, ensuring processes reflect contract terms and services requested. Monitors project financial status, forecasting, realization, and team allocations, coordinating staff projections and escalating financial or operational risks. Determines hours for out-of-scope work and justifies modification requirements. Resolves complex problems and may assist management with training and mentoring. Presents at business development, client, and investigator meetings, and participates in strategy calls.
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.