Start Up Senior Trial Manager, Early Development

Acting as a link between ED operational delivery and SSU start-up activities, the successful candidate will help drive quality, consistency and efficiency through process improvement, training, mentoring and implementation of harmonised ways of working.

Are you ready to join our team? Then please read further!

You Will Be Responsible For

Early Development / Local Trial Management:

• Acting as the primary local GCO contact for assigned ED&CP studies, leading local trial team activities in line with SOPs, procedures and regulations.
• Overseeing studies from start-up through conduct and close-out, supporting delivery of recruitment, quality, timelines and budgets.
• Supporting feasibility assessments, site selection and study planning, including risk and contingency management.
• Tracking study and country progress using trial systems and reports, identifying risks and issues, implement corrective actions and keep study teams informed.
• Reviewing monitoring reports, identifying trends across sites and supporting risk-based monitoring activities.
• Ensuring local oversight of safety and quality processes, including safety reporting, CAPAs, informed consent, data entry, recruitment performance and study supplies.

Study Start-Up / UK Regulatory And Ethics

• Acting as the country contact for ED study start-up activities, partnering with SSU colleagues and local/global study teams.
• Preparing, reviewing and supporting regulatory and ethics submissions, including clinical trial applications, essential documents and informed consent materials.
• Coordinating with internal and external partners to secure approvals required to start studies in the UK.
• Maintaining accurate records of submissions, approvals and start-up milestones, escalating risks and issues where needed.
• Providing guidance on UK regulatory, ethics and start-up requirements.

Collaboration, Process Improvement and People Contribution

• Building strong working relationships with investigators, site staff, study teams and key stakeholders.
• Working closely with Site Management, CTAs, PIPS/SIPS, CCS, Data Management, IDAR, Regulatory Affairs, Local Safety, Compliance and other partners.
• Supporting study amendments, training activities and process changes.
• Contributing to initiatives that improve study start-up, trial delivery, documentation quality and team ways of working.
• Mentoring and supporting LTMs, SMs and CTAs, and acting as a process champion or subject matter expert where appropriate.

Education & Experience Requirements

• BA/BS degree in Life Sciences, Nursing or related scientific field, or equivalent relevant experience.
• Minimum of 3- 5 years of UK clinical trial experience is preferred, including site monitoring and local EC submission experience! Knowledge of UK regulatory and ethical requirements for study start-up and local ethics / regulatory submission experience are preferred.
• Previous ED&CP clinical trial experience is preferred.
• Solid understanding of the drug development process, ICH/GCP, Healthcare Compliance requirements, SOPs and local regulatory requirements.
• Good leadership, stakeholder management and communication skills, able to influence across multidisciplinary local and global teams.
• Strong organisational and project management capability, able to work across multiple studies and disease areas in parallel.
• Strong written and verbal English communication skills, with high attention to detail and a quality mindset.
• Strong IT skills and confidence using clinical trial management systems, submission tracking tools, dashboards and standard office productivity tools.
• Demonstrated AI literacy and an AI-enabled mindset, including the responsible use of AI tools to improve productivity, decision making and quality of outcomes.
• Flexible mindset and ability to work at pace within small exploratory international study teams in a changing environment.
• Therapeutic area experience in Haematology, Oncology and/or Immunology is preferred, although experience across other therapeutic areas may also be valuable.
• Willingness to travel with occasional overnight stays where required by study needs.
• Flexibility to commute 3 x weekly to High Wycombe / Maidenhead UK is essential.

Benefits

We offer a competitive salary and extensive benefits package. The health and well-being of our employees is a priority, we have a flexible working environment as we value work-life balance. We offer career development opportunities for those who want to grow and be part of our organisation. For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits

All qualified applicants will be considered for employment without regard to any other characteristic protected by law. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform important job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodations.

Required Skills

• On Site Monitoring
• Study Start Up
• Submission Management

Preferred Skills

• Adaptability
• Business Behavior
• Clinical Research and Regulations
• Clinical Trial Designs
• Clinical Trial Management Systems (CTMS)
• Clinical Trials
• Communication
• Early Clinical Development
• Early Phase Clinical Trials
• Give Feedback
• Laboratory Operations
• Learning Capacity
• Medical Knowledge
• Mentorship
• Problem Solving
• Process Oriented
• Professional Ethics
• Project Integration Management
• Project Management
• Research and Development
• Research Ethics