Administrative team lead supporting University of Alberta Pharmacy faculty operations. Supervising staff, coordinating executive services and improving Dean’s Office processes.
About the role
- Clinical Team Lead overseeing Phase I clinical trial delivery for Fortrea’s clinical research services. Managing clinical strategy, sites, vendors, budgets, risks, and project teams remotely.
Responsibilities
- Provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinical research standards
- Own clinical delivery of clinical research trials and function as the Clinical Project Manager within the core project team
- Partner with the Project Manager and functional leads to ensure successful delivery of clinical trial activities within contractual and budgetary requirements
- Oversee clinical and site management aspects of trials and represent clinical delivery with customers
- Drive clinical project performance toward contracted deliverables while meeting customer needs and maintaining operational excellence
- Drive communication and collaboration with clients and project teams in a matrixed, multicultural environment
- Lead clinical project strategy development and prioritization, including management of project scope, timelines, quality and budget
- Prepare and deliver presentations for new business as required
- Manage project operations supporting subject recruitment and retention, clinical vendor delivery and monitoring visit strategy
- Identify clinical project, financial and quality risks using end-to-end risk management and quality-by-design principles
- Use data sources, dashboards and risk management strategies to drive innovation and proactive problem solving
- Maintain project governance and issue escalation pathways, including clinical project plans addressing identified risks
- Oversee clinical project budgets, resources and scope; ensure budget and financial milestone adherence
- Forecast clinical project revenue and manage project costs within budget
- Lead scope changes and the change order process; track KPIs for client-specific metrics
- Provide leadership for high-performing clinical project teams and facilitate communication, teamwork and delivery
- Ensure accurate clinical resource projections and escalate resource constraints
- Develop and mentor team members and provide feedback to line managers
- Participate in and oversee regulatory/ethics committee submissions, tracking and documentation
- Support new business through Bid Defense preparation and meetings
- Perform other duties as needed or assigned
Requirements
- 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
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements
- Fluent in English, both written and verbal
- 2+ years of Clinical Team Lead experience or an equivalent combination of education and experience to successfully perform key responsibilities of the job
- Phase I/FIH experience
- 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
- Preferred: Master or other advanced degree
- Preferred: PMP certification
- Preferred: 2+ years CRA experience, on-site or in-house
Benefits
- Equal Employment Opportunity and accommodations support
- Remote/homebased work arrangement
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