Senior Medical Project Coordinator

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Senior Medical Project Coordinator At Thermo Fisher Scientific, you'll do meaningful work that makes a positive impact on global health. You'll be part of a global organization supporting leading pharmaceutical and biotechnology companies while contributing to the development of life-changing therapies. Through collaboration, innovation, and continuous learning, you'll have the opportunity to grow your career while helping advance clinical research worldwide. What You'll Do: The Senior Medical Project Coordinator manages, coordinates and evaluates medical projects for one or more programs in collaboration with management and other stakeholders to ensure consistency, alignment, and compliance of internal processes as well as optimal performance and issue resolution throughout project lifecycle. Represents the company in the medical research community and develops collaborative relationships with client company personnel. • Work independently to perform first pass review of safety data, utilizing line listings, company dashboard(s) and/or other visualization tools. Review data for safety trends, coding consistencies, and potential follow up with investigator sites. Proactively identify any potential issues and resolve or escalate as appropriate. • Review safety data and provide summations for safety review meetings. Review designated sections of aggregate reports. • Independently function as the Project Lead for medical monitoring services when SAE case processing has not been contracted. Manage project implementation, coordination, maintenance and close out of assigned studies as applicable. Serve as the primary point of contact for clinical project teams on studies and can act as the alliance level lead on larger alliance/multi-protocol studies. • Create and maintain medical management plan(s) on studies (as applicable) and ensure that the processes included in the plan document are reflective of the contract and services requested for studies that have department involvement and those that are standalone studies (ex. MM and/or MPC). • Work independently to monitor the project financial status, unit forecasting, actual realization, and team allocations in systems. Coordinate staff projections based on contract values and actual hours used. Escalate any financial and/or operational risks and can attend risk management meetings to discuss. • Independently determine hours required for out of scope work for the teams and provide this to the finance/study team for contract modifications. Attend meetings to discuss/justify the modification requirements. • Resolve complex problems through in-depth evaluation of various factors and offers solutions. May assist management in training and mentoring. • Present at business development, client, and investigator meetings and participates in strategy/business development calls. Represent studies at risk management meetings. Education and Experience Requirements: • Bachelors degree in Nursing or related Health Sciences (Physician's Assistant) or licensed RN • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years), to include 5+ years clinical safety experience (clinical research monitoring, or pharmacovigilance or combination of clinical research monitoring and pharmacovigilance) In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills, Abilities: • Advanced knowledge of GCPs for medical oversight of clinical trials • Knowledge of drug development and safety reporting • Advanced knowledge of safety data trending to include coding • Working knowledge of biostatistics, data management and clinical procedures • Excellent problem solving and critical thinking skills • Excellent project management and budget skills • Effective mentoring skills and ability to train and lead others • Strong oral and written communication skills • Strong attention to detail • Ability to work in a collaborative team environment • Ability to maintain a positive and professional demeanor in challenging circumstances Working Environment: Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role: • Work is performed in an office/ laboratory and/or a clinical environment. • Exposure to biological fluids with potential exposure to infectious organisms. • Exposure to electrical office equipment. • Personal protective equipment required such as protective eyewear, garments and gloves. Work is performed in an office environment with exposure to electrical office equipment. • Occasional drives to site locations, frequent travels both domestic and international. Why join us? When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.