Description
We are looking for a Senior Global Trial Manager to join our Single Sponsor Department. As a core Clinical Trial Team (CTT) member, you'll lead critical aspects of global studies and collaborate across functions to drive success, delivering late-phase clinical trials that meet timelines, budgets, and quality standards.
This is a unique opportunity to specialize in one or more of the following role pathways:
- Scientific Review Committee (SRC)
- Non-Interventional Studies (NIS)
- Managed Access Programs (MAP)
- Investigator-Initiated Trials (IITs)
- Research Collaborations (RCs)
- Program Level Documents (PLD)
Key Responsibilities
- Plan, coordinate and oversee assigned Medical Affairs activities from operational set-up through maintenance, reporting and closure, ensuring deliverables and milestones are achieved on time and to the required quality standards.
- Act as the operational point of contact for assigned work and build productive relationships with global stakeholders, including Medical Affairs teams, study teams, investigators, external partners, reviewers, governance groups, CROs and other vendors.
- Develop, coordinate, review and maintain relevant study, program, submission and regulatory documentation, ensuring required inputs, approvals, decisions and records are complete and available in the appropriate systems.
- Coordinate the collection and timely completion of Global Medical Affairs inputs for program-level and safety documents, including DSURs, PSURs, Investigator Brochures, Addenda to Clinical Overviews and annual regulatory reports, where applicable.
- Organise and support kick-off, strategy, scientific review, governance and comment-resolution meetings, including preparation of pre-reads, agendas, supporting documentation, minutes, decisions and follow-up actions.
- Manage and maintain accurate operational information, trackers, panels, delegations, study or program status, metrics and reporting in relevant systems and databases.
- Plan and monitor budgets and resources, including investigational product or Post-Study Drug Supply forecasts where relevant, identifying impacts and escalating material changes for approval.
- Support the selection, contracting and oversight of CROs and third-party vendors, and monitor the performance of external partners where applicable.
- Identify, assess and manage operational, quality, compliance, GCP and delivery risks and issues; develop mitigation plans, escalate appropriately and support the timely completion of corrective and preventive actions.
- Monitor adherence to SOPs, working practices, GCP and other applicable requirements, maintaining audit and inspection readiness and supporting audit preparation, enquiries and corrective actions.
- Track assigned activities and outstanding items through to final resolution, ensuring timely execution, accurate reporting and effective communication of progress, decisions and dependencies.
- Contribute to process simplification, operational excellence, knowledge sharing and continuous improvement, promoting a strong culture of quality, integrity, collaboration and compliance.
What You'll Bring
- Advanced degree in life sciences or healthcare
- Minimum 5 years’ experience in planning, executing and reporting global clinical trials in a pharmaceutical company or CRO, preferably including at least 2 years managing Real World Evidence (RWE) or global late-phase studies (e.g. PASS, PAES, NIS), or relevant equivalent Medical Affairs experience (dependent on role pathway).
- Experience working in global, cross-functional matrix teams and building effective relationships with internal and external stakeholders.
- Ability to manage multiple studies or programs of work in parallel, consistently delivering to time, budget and quality expectations.
- Strong planning, communication, influencing, problem-solving and organisational skills, with the ability to work independently and manage ambiguity and change.
- A quality and compliance mindset, high attention to detail and the confidence to speak up, challenge constructively and drive issues to resolution.
- Experience contributing to relevant clinical study documents (e.g. protocols, PSURs, DSURs, regulatory submissions)