Clinical Development for the Digital Age
Clinical Strategy and Solutions Manager – Temp
Location
New York + 2 moreAll locations: New York, North Carolina, Massachusetts
Posted
63 days ago
Salary
$50 - $55 / hour
Seniority
Senior
Job Description
Job Requirements
- Bachelor’s degree required, preferably in physical or life science or statistics discipline
- 5-7+ years of Clinical Operations work experience at a sponsor company in pharmaceutical clinical trials preferred. Experience as a Clinical Research Associate a plus
- Oncology experience a plus
- Strong knowledge of clinical trials and drug development processes
- Ability to read and comprehend complex clinical trial protocols and designs
- Familiarity with clinical trial technologies (e.g., EDC, IRT, CTMS, ePRO, eCOA, eConsent, TMF)
- Knowledge of regulatory requirements and information governance frameworks (e.g. ICH, GCP, HIPAA, GDPR)
- Understanding of 21 CFR Part 11 compliance requirements and software development life cycle preferred
- Ability to understand and communicate architectural requirements, preferences, and limitations preferred
- Excellent team player with demonstrated track record of success in a cross-functional team environment; consistent commitment to delivering on team goals with a sense of shared urgency
- Ability to work up to 40 hours per week during the core hours of 8am to 5pm Eastern Time
- Open to candidates in the following states ONLY: New York, Massachusetts, North Carolina
Benefits
- Retirement Plan (401k)
- Flexible work hours
- Hybrid work environment
- Office Gym Access
- Employee Restaurant Discounts
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