Versatile Clinical Trials Manager with a strong track record in managing the full spectrum of clinical trials from design to delivery. Coordinates cross-specialty projects, optimising budget management and resource allocation to enhance operational effectiveness. Engages stakeholders and cultivates collaborative relationships to support successful trial outcomes.
Overview
10
10
years of professional experience
18
18
years of post-secondary education
Work History
Clinical Trials Manager
The Newcastle upon Tyne Hospitals NHS Trust
Newcastle upon Tyne
09.2021 - Current
Daily working with the multi-disciplinary team, responsible for the efficient and effective use of resources to deliver and support a broad portfolio of studies.
Managed team of over 25 research support staff, ensuring HR policy compliance and prioritising staff wellbeing.
Led the design and delivery of relevant education programs while identifying and meeting the training needs of research support staff.
Offered governance expertise and support aligned with Good Clinical Practice and local SOPs to uphold compliance.
Leading the team to support in the delivery of agreed performance targets and local and national KPI's.
Facilitated delivery of clinical research in accordance with contractual agreements, ensuring adherence to study timelines.
Budget management within teams, including appropriate study costing and rigourous recording of all research activity to enable timely invoicing. Including working closely with Finance.
Lead on cross-specialty and cross-directorate projects to deliver improvement, and objectives for the strategic priorities and vision of the Research Directorate and Trust. Including process improvement and implementation and change managment.
Extensive experience of phase 1-4 trials both commercially and non-commercially in ATIMP, CTIMP, Medical Device and Observational withia large scale of medical and surgical specialities.
Extensive knowledge and experience of Electronic Health Records and Electronic Data Capture Systems.
Extensive knowledge, skills and experience of all aspects of study design, set-up, delivery, close down and archiving along with all aspects of trial coordination and data management.
Played a key role in the roll out of the electronic site file in the first UK NHS site.
Point of escalation for Trial Coordination and Data Management, query resolution and problem solving.
Act as the point of escalation for key stakeholders to ensure effective communication and collaboration and ongoing delivery of trials.
Supported employee morale and well-being by developing positive practices centred on career development and individual job satisfaction. Worked in line with staff attendance policy, conducting return to work meetings, long term absence reviews and formal attendence reviews with warnings being provided.
Conducted performance reviews and identifying areas for development. Involvement with staff performance management process in line with HR policies.
Optimised workforce scheduling to balance team workload, preventing burnout and maintaining morale through regular one-to-ones and development opportunities.
Staff recruitment, development and retention with a proven track record of developing staff to promotion.
NIHR GCP Facilitator
Research & Development Project Manager
The Newcastle upon Tyne Hospitals NHS Trust
Newcastle Upon Tyne
10.2018 - 11.2021
Project Manager in Newcastle Hospitals Sponsorship Team working with Chief Investigator and Trust's to initiate multi-centre trials. Creating protocols, patient facing documents and all documents for Regulatory Review.
Developed comprehensive project plans, outlining scopes, timelines, and resources, facilitating smooth execution.
Created project plans, including Gantt charts, to outline timelines and resource allocation for successful execution.
Facilitated the preparation and submission of grants and contracts to ensure funding for initiatives.
Chaired Trial Steering Groups to provide strategic oversight and ensure alignment with trial objectives.; creating agenda, taking minutes and resolving actions ensuring groups met regularly and at timepoints of potential risk.
Identified and assessed potential risks in projects, implementing strategies to mitigate them.
Managed financial resources by monitoring budgets to maintain project costs within approved limits.
Implemented standard operating procedures (SOPs) to ensure consistency in project execution and compliance.
Conducted site monitoring visits to ensure compliance with trial protocols and regulatory requirements.
Delivering projects in line with project plans and objectives.
Writing funder reports.
Senior Clinical Trials Manager
The Newcastle Upon Tyne Hospitals NHS Trust
Newcastle upon Tyne
11.2020 - 09.2021
Led COVID Research Team to accelerate study set-up and delivery of vaccine trials, ensuring compliance with Good Clinical Practice amid a rapidly changing landscape.
Established a proven history of expediting the start-up process for research projects.
Engaged stakeholders across NIHR, Department of Health, commercial partners, and NHS Trusts to facilitate collaboration and support for clinical trials.
Leading a team of Trial Coordinators and Data Managers ensuring performance metrics met whilst also working in an extremely difficult environment.
Monitored staff performance and developed improvement plans.
Managed organisational resources to fulfil administrative and operational requirements while adhering to budgetary guidelines and maintaining quality and schedule standards.
Research Operations Office
NIHR
Newcastle upon Tyne
01.2016 - 10.2018
Cultivated relationships with GPs, community pharmacies, and NHS sites to enhance collaboration in research initiatives.
Setup of clinical trials in Primary Care and Secondary Care across the North East and North Cumbria region.
Managed high-pressure workload while travelling across a large region to promote and set up studies in diverse research environments.
Facilitated engagement at promotional events aimed at increasing awareness of clinical trials among speciality groups.
Served as the primary contact at Speciality Groups, delivering updates on study progress to stakeholders in the region.
Collaborated with team members to achieve target results.
Achieved service time and quality targets.
Engaged with customers to better understand needs and deliver excellent service.