Clinical Start-up & Trial Lead (Start-up + CTL)

Job Overview:

Clinical Team Leads (CTL) own the clinical delivery of clinical research trials. CTLs function as the Clinical Project Manager (CPM) within the core project team. CTLs partner with the Project Manager and other functional leads to ensure successful delivery of the clinical aspects of a trial within contractual and budgetary requirements. The CTL oversees the clinical and site management aspects of the trial. The CTL represents clinical delivery with the given customer.

Summary of 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
• may consider relevant and equivalent experience in lieu of educational requirements.
• Fluent in English, both written and verbal.

Experience (Minimum Required):

• 2+ years clinical research/monitoring 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.
• 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 Qualifications Include:

• Master or other advanced degree
• PMP certification 2+ years CRA experience, on-site or in-house
• In lieu of the above minimum requirement, candidates with three or more years of relevance clinical research experience in pharmaceutical, CRO or health care setting will be considered

Physical Demands/Work Environment:

• Standard Office Environment or remote based work required
• Weekend and off-hour work as required
• Travel Requirements: up to 30% (Global – primary domestic and international)

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