At a Glance
- Tasks: Lead operational planning and execution of clinical research studies, ensuring quality and timeline adherence.
- Company: Join a dynamic team focused on enhancing clinical research capabilities and operational effectiveness.
- Benefits: Enjoy a one-year contract with opportunities for professional development and mentoring.
- Other info: Experience in managing Phase I-IV studies is essential.
- Why this job: This role offers the chance to drive operational excellence in clinical trials across various phases.
- Qualifications: Requires a Bachelor’s degree in Life Sciences and 5-8 years of clinical research experience.
The predicted salary is between 60000 - 68231 £ per year.
Lead the planning, execution and oversight of clinical research studies while partnering with cross-functional stakeholders to drive operational excellence, study delivery and continuous improvement across the clinical trial lifecycle.
What you'll be doing:
- Lead the operational planning and execution of clinical research studies, ensuring delivery against study timelines, quality standards and business objectives.
- Act as the key liaison between internal and external stakeholders to facilitate effective study planning, execution and issue resolution.
- Partner with cross-functional teams to ensure seamless implementation of study protocols and operational requirements.
- Provide operational expertise and guidance on clinical trial processes, study feasibility, protocol implementation and regulatory requirements.
- Support protocol reviews and contribute operational insights to optimise study design and execution strategies.
- Drive study start-up, execution and close-out activities while ensuring alignment with project milestones and deliverables.
- Monitor study progress, identify operational risks and implement mitigation strategies to support successful study outcomes.
- Facilitate study governance activities, including project meetings, operational reviews and stakeholder communications.
- Ensure accurate tracking, reporting and communication of study metrics, milestones and key operational updates.
- Promote consistency, quality and compliance across clinical trial operations through the application of best practices and continuous improvement initiatives.
- Lead post-study reviews and lessons learned activities to identify opportunities for process enhancement and operational excellence.
- Maintain oversight of study documentation and operational records to support inspection readiness and regulatory compliance.
- Coach, mentor and develop team members while fostering a collaborative and high-performing team environment.
- Support departmental and organisational initiatives to strengthen clinical research capabilities and operational effectiveness.
What we're looking for:
- Bachelor Degree in Life Sciences/ Pharmacy/ Biomedical Sciences/ Nursing or related studies.
- 5 - 8 years of working experience managing and delivering clinical research studies within pharmaceutical, biotechnology, clinical research unit (CRU) or contract research organisation (CRO) environments.
- Strong experience supporting or managing Phase I, II, III and/or IV clinical studies across the clinical trial lifecycle.
- Sound knowledge of ICH-GCP guidelines, clinical trial regulations, ethics committee/IRB processes and clinical research best practices.
- Proven ability to lead cross-functional teams and manage multiple stakeholders in a matrix environment.
- Strong understanding of clinical trial operations, study management and operational planning.
- Experience identifying and implementing process improvements to enhance study execution and operational efficiency.
- Excellent communication, stakeholder management and problem-solving skills.
- Prior experience coaching, mentoring or leading team members will be advantageous.
- Proactive, strategic and results-oriented, with the ability to thrive in a dynamic clinical research environment.
Clinical Research Project Manager, Operations (1-Year Contract) in Penarth employer: JOBSTUDIO PTE. LTD.
This organisation is dedicated to advancing clinical research through innovative practices. Located in a vibrant area, they offer a collaborative environment that fosters professional growth. The team values continuous improvement and operational excellence in clinical trial management.
We think you need these skills to ace Clinical Research Project Manager, Operations (1-Year Contract) in Penarth
Operational Planning
Clinical Research Management
Stakeholder Management
Study Protocol Implementation
Regulatory Compliance
Project Milestone Tracking
Risk Identification and Mitigation