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Responsibilities:
- Lead and manage clinical trials.
- Develop study plans, timelines, and budgets.
- Coordinate with cross-functional teams.
- Develop country and site-specific documents.
- Manage site contracts and budgets.
- Provide training to junior CRAs and site staff.
- Conduct site qualification, initiation, and monitoring.
- Ensure compliance with protocols and regulations.
- Oversee data integrity and quality across sites.
- Monitor adverse events and resolve issues.
- Participate in SOP and work instruction development.
Requirements:
- Bachelor’s degree in life sciences or nursing.
- Minimum 5 years of Medical Device research experience.
- Experience in monitoring BPH or prostate cancer research.
- In-depth understanding of FDA regulations and GCP.
- Proficiency in CTMS, EDC systems, and MS Office.
- CRP or SoCRA certification preferred.
- Ability to travel up to 70%.
Benefits:
- Full medical coverage and wellness programs.
- On-site gym and 401(k) plan with employer match.
- Short-term and long-term disability coverage.
- Paid time off, parental leave, and holidays.
- Wellness benefits and life insurance.
