FSP - Clinical Team Lead - Ophthalmology - US & Canada
$135,000–$145,000 year
RemoteUnited States or Canada
Job Summary
Drive clinical project performance toward contracted deliverables by leading clinical strategy, managing site operations, and overseeing vendor delivery. Proactively identify financial, quality, and regulatory risks while managing budgets, scope changes, and resource projections. Lead cross-functional teams through study conduct, data management, and closeout, ensuring adherence to ICH Guidelines, GCP, and client requirements. Forecast revenue accurately and present to stakeholders for new business opportunities. Participate in regulatory submissions and bid defense meetings as needed. Manage weekend and off-hour work with up to 30% travel.
Required Qualifications
- 2+ years of experience
- Prior monitoring experience
- Remote US or Canada based
- University/college degree (life science preferred) or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution
- Fluent in English, both written and verbal
- Bachelor's degree
- 5+ years clinical research/monitoring experience or an equivalent combination of education and experience to successfully perform key responsibilities of the job
- 3+ year of experience of experience leading project teams through the start-up, study conduct, data management, analysis, close out and report writing of clinical studies
- Experience providing oversight to external vendors (e.g. CRO, central labs, call centers, DCT providers)
- Working knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs
- Advanced computer skills (e.g., Microsoft Word, Excel, Project, Access and Power Point)
- Experience managing projects in a matrix and virtual environment
- Excellent communication, planning and organizational skills
- Demonstrated ability to lead by example and to encourage team members to seek solutions independently
- Demonstrated ability to handle multiple competing priorities and to utilize resources effectively
- Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system
- Financial awareness and ability to actively and effectively utilize financial tracking systems
- Ability to work independently and mentor junior project team members
- Ability to negotiate and liaise with clients in a professional manner
- Ability to present to staff at all levels
- Weekend and off-hour work as required
- Travel Requirements: up to 30% (Global – primary domestic and international)
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