Clinical Team Lead, Phase I

Job Overview

The Clinical Trial Manager will utilize their skills, knowledge, and clinical judgement to provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinical research standards.

Responsibilities

• Take accountability for proactively driving clinical project performance toward contracted deliverables while meeting customer needs and maintaining operational excellence.
• Drive communication and collaboration with the client and project team across a matrixed, multicultural environment.
• Lead the development of the clinical project strategy and ensures prioritization with the clinical project team and key stakeholders in the creation of clear, data-driven strategies and proactive management of project scope, timelines, quality and budget.
• In collaboration with relevant departments, prepare and deliver presentations for new business as required.
• Manage the operational aspects of projects to support subject recruitment and retention, clinical vendor delivery and oversee the monitoring visit strategy.
• Identify clinical project, financial and quality risks leveraging end-to-end risk management practices and quality by design principles.
• Appropriately utilize data sources, dashboards and risk management strategies to drive innovation and proactive problem solving with the project and client teams.
• Adhere to project governance and issue escalation pathways, ensuring that clinical project plans are in place to address identified risk while adhering to professional standards, SOPs, client and regulatory requirements.
• Partner with project team members and key stakeholders to oversee and manage clinical project budgets, resources and scope.
• Ensure adherence to established budget and financial milestones. Accountable for accurately forecasting clinical project revenue and managing project costs in adherence to the budget.
• Leading the timely management of changes to scope and the change order process. Ensures project team awareness and tracking of KPIs for any client-specific metrics.
• Provide inspiring leadership and play a key role in the creation of high-performing clinical project teams. Facilitating communication and teamwork while driving delivery, ensuring that clinical team members understand contracted scope, timelines and budget.
• Ensures that clinical resource projections are accurate and visible to resourcing teams, proactively escalating resource constraints and challenges.
• Develops and mentors team members in multiple areas of expertise and provide feedback as needed to respective line managers.
• As required by the project roles, participate and oversee the regulatory/ethics committee submissions, tracking, and documentation.
• Support new business with active participation in Bid Defense preparation and meetings, as required.
• And all other duties as needed or assigned.

Qualifications (Minimum Required)

• 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.
• Forte may consider relevant and equivalent experience in lieu of educational requirements.
• Fluent in English, both written and verbal.
• Experience (Minimum Required): 2+ years of Clinical Team Lead experience or an equivalent combination of education and experience to successfully perform key responsibilities of the job.
• 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.
• Demonstrated ability to negotiate and liaise with clients in a professional manner.
• Demonstrated ability to present to staff at all levels.

Preferred Qualifications

• Master or other advanced degree.
• PMP certification.
• 2+ years CRA experience, on-site or in-house.
• Phase I/FIH experience.