FSP Study Manager
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Job Location:
Durham, NC - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
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.
Additionalresponsibilities 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 Sciencespreferred)
Experience:
Minimum3 years of relevant clinical research experience in a pharmaceutical company and/or CRO
Pharmaceutical and clinical drug development experience
Experience creating Meeting Minutes
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
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
US Pay Range:$115000 - $140000/year
Benefits:All job offers will bebased on a candidates skills andpriorrelevant experience applicabledegrees/certificationsas well as internal equity and market full-timeor 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 pleaseclick 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.
Learn more about our EEO & Accommodations request here.
Required Experience:
Manager
