We are seeking an experienced and highly motivated Senior Trial Manager to lead the operational delivery of the PARTNERS Trial —an innovative international adaptive platform trial designed to strengthen the global response to filovirus outbreaks.
This is an exciting opportunity to play a pivotal role in delivering complex, multi-country clinical research that has the potential to improve outbreak preparedness and save lives. Working with an international network of investigators, sponsors, regulators, and collaborating institutions, you will oversee all aspects of trial management, from study set-up through to close-out, while ensuring the highest standards of quality, compliance, and operational excellence.
As Senior Trial Manager, you will provide strategic and operational leadership for the PARTNERS Trial, ensuring its successful delivery across multiple international sites. You will work closely with multidisciplinary teams and global partners to coordinate trial activities, maintain regulatory compliance, support epidemic response activities, and strengthen platform readiness between outbreaks.
This is a varied and rewarding role requiring exceptional organisational, leadership, and communication skills, together with extensive experience managing complex international clinical trials.
You will:
- Lead the operational delivery of the PARTNERS Trial across all phases, including study set-up, site activation, recruitment, monitoring, outbreak response, and study close-out.
- Manage day-to-day trial operations, proactively identifying, managing, and resolving operational risks and challenges.
- Ensure all trial activities comply with ICH-GCP, applicable regulatory requirements, sponsor expectations, and University policies.
- Contribute to the strategic operational planning of an adaptive platform trial designed for epidemic settings.
- Act as the senior operational contact for international coordinating centres and collaborating partners, providing oversight of site management and ensuring consistent, high-quality trial delivery.
- Coordinate ethics and regulatory submissions, amendments, approvals, and reporting requirements across multiple countries.
- Organise and support Trial Management Group, Trial Steering Committee, Data Safety Monitoring Board (DSMB), and stakeholder meetings.
- Maintain inspection and audit readiness, including oversight of the Trial Master File (TMF) and essential study documentation.
- Oversee data management activities, including monitoring, data query resolution, CRF management, randomisation, and data quality processes.
- Coordinate programme work packages, patient and public involvement and engagement (PPIE) activities, and laboratory documentation.
- Support rapid activation of trial operations during filovirus outbreaks, including emergency site mobilisation and operational coordination.
You will:
- Monitor trial budgets, forecasts, invoicing, and financial reporting.
- Review collaborator invoices and ensure compliance with contractual and funder requirements.
- Prepare reports, presentations, and operational updates for sponsors, collaborators, funders, and governance committees.
You will:
- Line manage temporary and junior trial management staff where appropriate.
- Provide training, supervision, and operational guidance.
- Foster effective collaboration across multidisciplinary and international teams.
You will:
- Lead preparedness activities to maintain platform readiness between outbreaks.
- Develop and improve trial management systems, SOPs, and operational documentation.
- Coordinate monitoring visits, audits, inspections, and quality improvement initiatives.
- Work with partner sites to strengthen operational processes, infrastructure, and regulatory preparedness.
- Deliver training for local research teams in GCP, protocol implementation, safety reporting, and trial operations.
- Support simulation exercises and site readiness assessments to enhance outbreak response capability.
You will bring significant experience in international clinical trial management and have a passion for delivering high-quality research in challenging and dynamic environments.
You will have:
- A degree in Global Health, Life Sciences, or a related discipline.
- Extensive experience managing complex clinical trials or large international multi-site research studies.
- Demonstrable experience delivering clinical trials across multiple countries and regulatory jurisdictions.
- Strong knowledge of ICH-GCP, clinical trial regulations, and research governance requirements.
- Experience coordinating international ethics and regulatory submissions.
- Proven ability to build and manage relationships with sponsors, funders, investigators, regulators, and external collaborators.
- Excellent project management and organisational skills with the ability to manage competing priorities independently.
- Experience identifying and resolving complex operational challenges within clinical research.
- Experience supervising, training, or coordinating research staff.
Vacancy ID 23630
