Job Description
Summary:
We are seeking an experienced and proactive Clinical Research Project Manager to join our growing team. The role involves leading the successful coordination and delivery of clinical trials across multiple sites. You will be responsible for overseeing the study start-up phase, including site feasibility, regulatory submissions, and site readiness, ensuring timely trial launch. Additionally, you will manage project timelines, budgets, and resources, while ensuring the highest standards of operational excellence, regulatory compliance, and client satisfaction. As the central liaison between internal teams and external stakeholders, you will drive projects to meet key performance indicators (KPIs) and strategic objectives.
Key Responsibilities:
* Study Start-Up Management: Coordinate all operational aspects of the study start-up phase, including site feasibility, selection, initiation, and regulatory submissions.
* Project Planning and Delivery: Develop detailed project plans, timelines, and resource plans, proactively identifying and managing risks and issues to ensure milestones are met on schedule.
* Client Liaison: Serve as the primary point of contact for clients, providing regular updates on study performance, managing expectations, and ensuring client satisfaction throughout the project lifecycle.
* Internal Coordination: Lead cross-functional collaboration with internal teams (Clinical Operations, Quality, Compliance, Operations) to ensure project goals are achieved.
* Budget and Financial Management: Maintain project budgets, track financial performance, and provide regular updates to ensure alignment with forecasted spend and capture out-of-scope costs.
* Regulatory Compliance: Ensure all projects are conducted in compliance with GCP, ethical standards, and relevant clinical trial regulations.
* KPI Monitoring: Track project performance against KPIs, providing regular reports and updates to both internal and external stakeholders.
* Process Improvement: Identify opportunities for process improvement and contribute to the development and implementation of best practices across projects.
* Contract and Proposal Support: Work closely with the commercial team to provide operational input during proposal, budget, and feasibility assessments, ensuring the operational feasibility of contracts and statements of work (SOWs).
* Risk and Issue Resolution: Proactively monitor and resolve project-related issues, ensuring projects are delivered on time, within scope, and on budget.
Essential Experience:
* Proven experience in project management within a clinical research setting (SMO, clinical site network, CRO, or similar).
* Strong understanding of clinical research operations, including study start-up, recruitment, and monitoring.
* Solid knowledge of GCP, clinical trial regulations, and ethical standards.
* Proficient in project management tools and Microsoft Office Suite.
* Demonstrated ability to manage multiple concurrent projects and meet deadlines.
* Experience managing project budgets and understanding the financial aspects of clinical research.
Preferable Qualifications:
* Degree in life sciences, healthcare, or a related field.
* Background in site coordination, clinical operations, or regulatory affairs.
Key Skills:
* Client Management: Strong communication and client management skills with the ability to build trust and influence outcomes.
* Strategic Thinking: Ability to think strategically and resolve problems to influence project delivery.
* Organisational Skills: Exceptional attention to detail with strong organisational and problem-solving abilities.
* Communication: Excellent written and verbal communication skills, with the ability to engage stakeholders at all levels.
* Adaptability: Ability to thrive in a fast-paced environment and deliver results under tight deadlines.
Other Requirements:
* Full UK residency and a valid driving license (public transport may not be suitable due to the location of the offices).
* Willingness to travel throughout the UK and overseas as required.