Senior Research Project Manager

Lancashire Teaching Hospitals NHS Foundation Trust; Sheffield; On-site; GBP 60,000 - 75,000; Full time

Job summary

Lancashire Teaching Hospitals NHS Foundation Trust is seeking a Senior Project Manager to lead end-to-end management of complex clinical trials across Lancashire and South Cumbria, coordinating multi-disciplinary teams and external partners.

You will ensure regulatory and GCP compliance, feasibility reviews, ethics submissions, and robust governance, while delivering timely reports and updates to funders and sponsors, and promoting continuous improvement within the research portfolio.

Qualifications

• Masters degree or equivalent in a relevant discipline.
• Evidence of education/training in clinical research governance.
• Good Clinical Practice (ICH-GCP) certification (current) and UK research governance knowledge.

Responsibilities

• Lead end-to-end management of complex clinical trials across Lancashire and South Cumbria.
• Develop and maintain trials governance, feasibility, and regulatory documentation.
• Coordinate multi-disciplinary teams and liaise with sponsors, NHS Trusts, and regulatory bodies.

Skills

Project management

Clinical research governance

GCP compliance

Education

Masters degree

Degree or equivalent in a relevant discipline

Postgraduate certificate in clinical research

Job description

Detailed job description and main responsibilities

• Ensuring all study setup processes and procedures of complex clinical trials are in line with regulatory requirements
• Using expert research governance knowledge develop, lead and manage a research hub and spoke network across different organisations
• Lead engagement with a variety of professionals across organisations to ensure the research hub and spoke model meets their needs
• Streamline site activation processes across the 'network' to ensure LTHTr meets local and national metrics
• Produce high-quality project reports, dashboards, and updates for funders, sponsors, and senior management.
• Promote a culture of continuous improvement and knowledge sharing
• Maintain accurate and auditable records of research activity, milestones, metrics and deliverables in line with contractual reporting schedules
• Coordinate and prepare reports, dashboards and performance updates to support internal oversight and external partnership review meetings.
• Ensure that information shared with external partners is managed in accordance with confidentiality, and information governance requirements.

Provide expert help and advice to investigators on running clinical trials to ensure high quality of research and safety of clinical trial patients, including advice on regulatory and GCP compliance matters. Ensure adherence to Health Research Authority (HRA) requirements as per HRA approvals.

The Senior Project Manager will be expected to have a strong understanding of regulatory and GCP guidelines, as well as local R&I SOPs and Policies.

Effectively utilising research portfolio management systems to project manage studies and communicate progress to the rest of the team.

As first point of contact for internal/external researchers/research teams and act as 'front door' contact. As an ambassador for the Trust you will exhibit high standards of customer service to ensure repeat business from external sponsors and continued engagement from internal and regional colleagues

Coordinate the feasibility process for research studies before set-up:

• Lead accelerated feasibility reviews of trials to meet targets, autonomously engaging with departments across NHS Trusts within Lancashire and South Cumbria
• Feedback feasibility review outcomes to the appropriate stakeholders
• Liaise with industry partners to ensure studies are costed appropriately

The Senior Project Manager will lead the planning and implementation of complex research trials or portfolios of across Lancashire and South Cumbria by:

• Lead the end-to-end management of research trials, including initiation, planning, execution, monitoring, and closure
• Develop and maintain detailed project plans, and resource allocation strategies
• Coordinate multi-disciplinary teams and facilitate effective communication among stakeholders
• Contribute to the development and implementation of research governance and quality assurance processes and procedures
• Develop and maintain comprehensive project documentation including timelines, Gantt charts, and risk logs
• Act as the primary liaison between research teams, collaborators, funders, and regulatory bodies.
• Facilitate regular project meetings and communication updates.
• Build and maintain strong working relationships with internal and external stakeholders
• When required, support the preparation and submission of ethics applications, amendments, and regulatory documentation
• Identify, assess, and manage project risks and issues
• Escalate critical issues to senior leadership as appropriate
• Respond to any queries regarding the progress of set up for research studies across the portfolio and support the local and national reporting obligations of the Trust and the NIHR CRN as required.

Is responsible for leading the service by being a visible and strong role model providing leadership and direction to the team and advising staff and students across Lancashire and South Cumbria to reach their full potential

As a responsible member of the Research Development team, balance your workload effectively to maintain a high-quality service and elevate pressures as appropriate.

Person specification

Qualifications & Education

Essential criteria

• Masters degree
• Degree or equivalent professional qualification, or demonstrable equivalent experience, in a relevant discipline
• Evidence of education and/or training in clinical research governance
• Highly developed Professional knowledge, underpinned by theory and experience.
• Good Clinical Practice (ICH-GCP) certification (current) Health Research Authority (HRA) approvals and UK research governance processes

Desirable criteria

• Post graduate certificate in clinical research or similar post-qualified qualification or diploma in a relevant pharmaceutical field.
• Project management qualification

Knowledge & Experience

Essential criteria

• The post holder must maintain up-to-date knowledge of research governance, regulatory and contractual requirements applicable to externally sponsored and collaborative research.
• Previous experience of project work, audit and change management
• Knowledge of clinical trial management
• Experience of product development
• Evidence of working within GCP guidelines
• Previous experience in clinical trials activity.
• Practical experience in start-up, smooth ongoing operation and completion of a clinical trial management on site, provision of adequate documentation and communication with the relevant people involved.

Desirable criteria

• Experience of clinical research.
• Phase 1 / 2 Clinical Trials experience

We are committed to promoting equality of opportunity, celebrating and valuing diversity and eliminating any form of unlawful discrimination across our workforce, ensuring our people are truly representative of the communities we serve.

All individuals regardless of race, age, disability, ethnicity, nationality, gender, gender reassignment, sexual orientation, religion or belief, marriage and civil partnership, neurodiversity or veteran status are encouraged to apply for this post.

Our Statement on the Recruitment of Ex-Offenders is available