Senior Site Manager, Radiopharmaceutical - FSP

Fortrea's FSP team is hiring a Senior Targeted Alpha Therapy Expert! We are seeking candidates with experience in Oncology and Radiopharmaceuticals. Home Based in the US or Canada.

Job Overview:

The manager 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:

• Reviews and evaluates CPS proposals and provides clinical and scientific support, as needed. This includes drafting study outlines/designs and providing guidance on early clinical development strategies.
• 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 CPS’s representative on studies/programs.
• 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 sites, 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.
• Performs other related duties as assigned.

Qualifications (Minimum Required):

• Bachelors or Master’s degree in an applicable scientific field, plus 4-6 years of relevant experience; or a PhD degree in an applicable scientific field.
• Experience dealing with hospitals and setting up clinical sites
• Radiopharmaceutical experience is a must
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Knowledge of GCPs and regulatory agency guidelines.

Experience (Minimum Required):

• Up to 5 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:
• Regional less than 50% of the time, which will require an overnight stay.

Pay Range: $145-155K USD

Benefits: All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable.  For more detailed information, please click here.    

Applications will be accepted on an ongoing basis.

Learn more about our EEO & Accommodations request here.