Description
Job Overview
We are seeking a Clinical Team Lead (CTL) to oversee the clinical delivery of clinical research trials. As a CTL, you will function as a Clinical Project Manager (CPM) within the core project team, partnering with the Project Manager and other functional leads to ensure successful delivery of the clinical aspects of a trial within contractual and budgetary requirements.
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 ensure prioritization with the clinical project team and key stakeholders.
- 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.
- 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.
- Lead the timely management of changes to scope and the change order process.
- Provide inspiring leadership and play a key role in the creation of high-performing clinical project teams.
- Develop and mentor team members in multiple areas of expertise.
Qualifications (Minimum Required)
- University/college degree (life science preferred) or certification in a related allied health profession.
- Fluent in English, both written and verbal.
Experience (Minimum Required)
- 2+ years of clinical research/monitoring experience or an equivalent combination of education and 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 PowerPoint).
- Experience managing projects in a matrix and virtual environment.
- Excellent communication, planning, and organizational skills.
Preferred Qualifications Include
- Master or other advanced degree.
- PMP certification.
- 2+ years of CRA experience, on-site or in-house.
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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