Senior Clinical Scientist

Job Overview: The Clinical Scientist (CS) Provides ongoing in-depth analysis and scientific input into development and execution of protocols and clinical development plans by working with the medical/scientific/regulatory team to creatively solve a wide range of medical/scientific/clinical/regulatory problems. The CS works with the Medical Monitor/study support on a protocol/program basis for early clinical trials. Summary of Responsibilities: Provides ongoing in-depth analysis and scientific input into development and execution of protocols and clinical development plans. Remains current on issues in scientific expertise through active, ongoing participation in relevant scientific meetings and courses. Works with the medical/scientific/regulatory team to creatively solve a wide range of medical/scientific/clinical/regulatory problems. Establishes and maintains close affiliations with the Fortrea and larger scientific community. Provides writing, review, editing and QC of applicable project documents, including: proposals, synopses, protocols, amendments, reports, narratives, investigator brochures, informed consent forms, manuscripts, clinical development plans and analysis plans that meet scientific and regulatory standards, as applicable. Provides scientific and logistical rationale/input for including biomarkers or other lab markers in Proof-of-Concept (POC) studies. Interacts with Fortrea Early Phase Development Solutions (EPDS) and participates on Molecule Development Teams as the early clinical representative. Oversee or assist in the planning and conduct of DSMB, Safety Review Committee, Cohort Review, Dose Escalation, Data Review or other medical-related study meetings. Writes draft Medical Responsibility, Safety and other related plans and facilitates their review and approval by Medical Monitor, Project Managers and Sponsors, as needed. Attends Kick-off Meetings and SIVs/Investigator Meetings. Supports training in key medical/scientific areas. Attends Team Meetings. Ensures that any medical/safety issues discussed at the meeting are resolved by the Medical Monitor in a timely manner. Serves as a resource for the Medical Monitor by tracking and reviewing ongoing studyspecific safety data (e.g., adverse events, vitals, ECGs and safety lab results) to identify safety trends. Acts as a liaison between the Medical Monitor in all communications between study sties, Fortrea project staff and Sponsors regarding protocol or other study-related questions, including documenting, tracking and follow-up on all issues. Supports CPS Medical Monitors in tracking and documenting any Inclusion/Exclusion criteria or protocol-related questions and answers. Supports the Medical Monitor in the review and interpretation of data from clinical studies, including data files, tables, figures and listings. Ensures SAEs are handled appropriately and in a timely manner. Supports Medical Monitor and Project Teams by reviewing SAE reports for completeness. Interacts with Fortrea/Sponsor/3rd Party safety groups, as needed to support SAE management. Participates in and/or leads process improvement initiatives such as establishing and improving document standards, documentation processes, developing new procedures, process mapping and SOP review/revision. All other duties as needed or assigned. Qualifications (Minimum Required): Bachelor's degree in an applicable scientific field, plus 10-12 years of relevant experience; or a Master's degree in an applicable scientific field, plus 4-6 years of relevant experience; or a PhD degree in an applicable scientific field. Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Knowledge of GCPs and regulatory agency guidelines. Ability to conduct limited review of related literature and references to obtain the required information and subsequently apply it. Skilled in data interpretation. Fluent in English, both written and verbal. Experience (Minimum Required): Up to 10-15 years of relevant experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, or data management). Additional experience may be substituted for education requirements. Physical Demands/Work Environment: Office working conditions. Overtime and weekend work as required. Travel Requirements less than 10% Regional. Learn more about our EEO & Accommodations request here. Didn't find what you were looking for? Join our Global Talent Network to stay connected with Fortrea, drive innovation and contribute to our mission of advancing life-saving therapies for patients worldwide. Follow us and stay updated about Fortrea on LinkedIn, Facebook, X, Instagram, YouTube and Glassdoor. At Fortrea, we're all about turning the impossible into "I'm possible." Together, we break barriers to deliver exceptional service to our patients, fueled by a shared commitment to teamwork and excellence. Regardless of your role, we're all family, working together to achieve extraordinary results. At Fortrea, your career isn't just a job - it's a journey of making the exceptional possible, every day.