FSP - Study Manager

Study Manager- FSP-RemoteUS 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:

• 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

Requirements:

Education:

• BS/BA/MS/Ph.D. (Life Sciences preferred)

Experience:

• 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

US Pay Range:$115,000 - $140,000/year

Benefits: All job offers will bebased on a candidate's skills and prior relevant experience, applicabledegrees/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.

Physical Requirements:

• 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.