Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.

• Works independently to perform and/or lead first pass review of safety data utilizing line listings, company dashboard(s), and/or other visualization tools. Reviews data for safety trends, coding consistencies, and potential follow up with investigator sites. Proactively identifies any potential issues and resolves or escalates as appropriate.
• Reviews safety data and provides comprehensive summations for safety review meetings. Reviews designated sections of aggregate reports.
• Initiates and leads initiatives to improve current processes and develops new processes regarding medical monitoring and department services. May develop guidance documents and assists with the implementation and/or revision of corporate level documents such as SOP's and WPD's.
• Independently functions as the Project Lead for medical monitoring services when SAE case processing has not been contracted. Manages project implementation, coordination, maintenance and close out of assigned studies as applicable. Serves 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.
• Creates and maintains safety and medical management plan(s) on studies (as applicable) and ensures that the processes included in the plan document are reflective of the contract and services requested for studies that have department involvement as well as standalone studies (ex. MM and/or MPC).
• Works independently to monitor the project financial status, unit forecasting, actual realization, and team allocations in systems. Coordinates staff projections based on contract values and actual hours used. Escalates any financial and/or operational risks and can attend risk management meetings to discuss.
• Presents at business development, client, and investigator meetings and participates in strategy/business development calls. Represents studies at risk management meetings.
• Independently determines hours required for out of scope work for both the MM and MPC and provides this to the finance/study team for contract modifications. Attends meetings to discuss/justify the modification requirements.
• Trains and develops new team members. Serves as main point of contact for team member questions with escalation to management as appropriate. May provide input on individual performance to direct line manager. Organizes and leads meetings with team members to discuss potential process issues, answer questions, and brainstorm ideas and solutions.
• Resolves complex problems through in-depth evaluation of various factors and offers solutions.

• 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 8+ years), to include 8+ years clinical safety experience (clinical research monitoring, or pharmacovigilance or combination of clinical research monitoring and pharmacovigilance)

• Superior knowledge of GCPs for medical oversight of clinical trials
• Advanced Knowledge of drug development and safety reporting
• Advanced Knowledge of safety data trending to include coding
• Advanced knowledge of biostatistics, data management and clinical procedures
• Exceptional problem solving and critical thinking skills
• Exceptional project management and budget skills
• Excellent mentoring skills and ability to train and lead others
• Exceptional oral and written communication skills
• Provides outstanding attention to detail
• Ability to work in a collaborative team environment
• Ability to maintain a positive and professional demeanor in challenging circumstances