What are the responsibilities and job description for the FSP - Study Manager position at Fortrea?
Study Manager - FSP - Remote US or CAN
We are seeking a Study Manager to be responsible for the operational conduct of clinical studies (e.g., CTT minutes, clinical supplies planning/tracking, lab specimen tracking, imaging data reconciliation, status update reports, study closeout activities); may support a single study or multiple studies; and other duties, as assigned.
Additional responsibilities may include:
Education:
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), Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable. For more detailed information, please click here.
Physical Demands/Work Environment
Work Environment:
We are seeking a Study Manager to be responsible for the operational conduct of clinical studies (e.g., CTT minutes, clinical supplies planning/tracking, lab specimen tracking, imaging data reconciliation, status update reports, study closeout activities); may support a single study or multiple studies; and other duties, as assigned.
Additional responsibilities may include:
- Lead a study with limited scope (e.g., Survival Follow-up)
- Responsible for tracking study timelines and will be proficient in project management tools
- Interact with internal and external stakeholders (study sites, vendors, committees, etc.) in support of clinical study objectives
Education:
- BS/BA/MS/Ph.D. (Life Sciences preferred)
- Minimum 3 years of relevant clinical research experience in a pharmaceutical company and/or CRO
- Pharmaceutical and clinical drug development experience required
- Experience creating Meeting Minutes required
- Advanced computer skills, including Microsoft Word, Excel, PowerPoint (MS Project preferred/beneficial)
- Excellent oral (including presentation) and written communication, computer/database management, and project management skills required
- Working knowledge of ICH Guidelines and GCP, including international regulatory requirements for the conduct of clinical development programs
- Ability to resolve project-related problems
- Demonstrated organizational skills and the ability to prioritize and multitask
- Demonstrated ability to work within a matrix system
- TA-specific experience in Oncology required
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), Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable. For more detailed information, please click here.
Physical Demands/Work Environment
Work Environment:
- Work is performed in an office environment with exposure to electrical office equipment.
- Frequent travel to clients/ site locations with occasional travel both domestic and international.
- Ability to sit for extended periods and operate a vehicle safely.
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
- Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
- Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
- Regular and consistent attendance.
- Varied hours may be required.
Salary : $115,000 - $140,000