Clinical Team Lead, Phase I
New
F
FortreaClinical research
Source API remote eligibility restrictions: United StatesFull-TimeLead
Salary135,000 - 145,000 USD per year
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Job Details
- Languages
- Fluent in English, both written and verbal.
- Experience
- 2+ years of Clinical Team Lead experience or an equivalent combination of education and experience to successfully perform key responsibilities of the job.
- Required Skills
- Microsoft AccessMicrosoft ExcelPowerPoint
Requirements
- Hold a university/college degree, preferably in life science, or certification in a related allied health profession such as nursing, medical technology, or laboratory technology; relevant equivalent experience may be considered.
- Have 2+ years of Clinical Team Lead experience or an equivalent combination of education and experience.
- Have working knowledge of ICH Guidelines, GCP, and international regulatory requirements for clinical development programs.
- Have advanced computer skills, including Microsoft Word, Excel, Project, Access, and PowerPoint.
- Have experience managing projects in matrixed and virtual environments.
- Demonstrate financial awareness and ability to use financial tracking systems.
- Be able to work independently and mentor junior project team members.
- Be able to negotiate and liaise professionally with clients and present to staff at all levels.
- Be able to manage competing priorities and use resources effectively.
- Preferred: a master’s or other advanced degree, PMP certification, 2+ years of CRA experience, and Phase I/FIH experience.
- Frequent travel to client and site locations; travel may be up to 30%, including domestic and international travel.
- Weekend and off-hour work may be required.
Responsibilities
- Drive clinical project performance toward contracted deliverables while meeting customer needs.
- Lead clinical project strategy and coordinate prioritization with the project team and stakeholders.
- Manage project scope, timelines, quality, budget, subject recruitment and retention, clinical vendors, and monitoring visit strategy.
- Identify clinical, financial, and quality risks and use data, dashboards, and risk management practices to support proactive problem solving.
- Oversee project budgets, resources, financial milestones, revenue forecasting, costs, scope changes, and change orders.
- Lead communication and collaboration with clients, project teams, and key stakeholders.
- Build high-performing clinical project teams, mentor team members, and support effective teamwork.
- Oversee regulatory and ethics committee submissions, tracking, and documentation as required.
- Support new business through bid defense preparation and meetings as required.
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