J&J Family of Companies Senior Clinical Trial Manager (2 of 2 positions) in High Wycombe, Netherlands
Job Title: Senior Clinical Trial Manager
Location: UK, Poland, Netherlands or Belgium
Who is Janssen? We’re more than 30,000 people working hard to prevent, treat, cure and stop some of the most devastating and complex diseases of our time. From heart disease to HIV, Alzheimer’s disease to cancer, we are committed to issues that touch everyone’s lives. Our mission is to transform individual lives and fundamentally change the way diseases are managed, interpreted, and prevented. We believe that challenging something is the best way to change it. So every day, in more than 150 countries, we bring cutting-edge science and the most creative minds in the industry together to think differently about diseases. We aim not only to innovate but also to empower people with the tools they need to make informed decisions and achieve the best possible results for their health.
We are looking at a future where the world of healthcare will be challenged by informed and empowered patients. We work for change that will improve access to medicines: the best available treatment at an affordable price. That’s why we at Janssen strive to provide access to effective and affordable medicines and related healthcare services to the people who need them.
We are recruiting for a number of Senior Clinical Trial Managers to be based in either the UK, Poland, Netherlands or Belgium. The Senior Clinical Trial Manager will ensure regional/global clinical operations deliverables progress according to agreed upon timelines and milestones as leader of the Study Management Team (SMT). This includes country & site feasibility and site selection, trial set-up, study execution and trial closure and vendor set up activities as assigned by the GTL.
Support GTL in leading related CRO country & site activities.
Study Management Team Leader
Leads the SMT, drives issue resolutions, and provides updates to all Trial Team members on the deliverable status.
Ensures required reports are generated and available for real time tracking of trial status.
Manage timely and accurate documentation, communication of study progress and issue escalation
Site selection, enrollment, monitor study progress
Coordinate the data collection and prepare/ drive the site selection decision process
Establish enrolment commitments and ensure actual enrolment meets projected commitments across the regions at the clinical trial level. Ensures the availability of robust recruitment/contingency plans are in place for each region
Ensures timely and accurate documentation and communication of study progress and issue escalation.
Financial planning and tracking
Set-up country budgets and monitor actuals vs forecast for Out of Pocket Expenses, and review assigned vendor invoices/spend.
Ensures accurate budget management for assigned trials, including the budget updates in line with scope & follows up on budget variances. This includes ensuring vendors and affiliate budgets are tracked according to plan. Updates are made to proactively account for scope changes.
Creates and updates study-specific documents such as Monitoring Guidelines, Informed Consent Form, Investigational Medicinal product (IMP) related documentation, Blinding Plan, country and site feasibility related documents. Provide input into cross functional documents such as Safety related documents, Protocol Deviations and Issue Escalation processes, External Service Provider Oversight Plan, Filing and Archiving Plan.
Training and Investigator Meeting
Create appropriate trial-specific training materials and requirements, making them available to the regional/site/CRO staff and delivering training as needed.
Responsible for the set-up and coordination of Investigator Meetings.
Cross functional Study Management
Act as the primary contact person for the local teams within GCDO. Establish and maintain excellent working relationships with internal stakeholders, such as country representatives, data management leader and clinical supplies unit.
Demonstrates deep knowledge of protocol and procedures and adequate therapeutic area knowledge.
Continuous Quality Focus
Ensure compliance with global Health Authority regulations and guidelines and internal operating procedures and processes. Participate in preparation for, and conduct of, Health Authority inspections and internal audits.
Ensure that the Study Management Team (SMT) operates in a constant state of inspection-readiness.
Work with Bioresearch Quality & Compliance (BRQC) liaisons to ensure quality oversight of assigned trial utilizing the available tools.
Coordinate data cleaning independently towards a timely and successful database lock
Willing to travel up to 20% of time.
Required Minimum Education: BS degree or equivalent required, preferably in Life Sciences. Experience in the Pharmaceutical industry or CRO.
What we’re about:
We are passionate about our work, and play vital roles across a range of professional disciplines, and care deeply about our customers and communities. At Johnson & Johnson our culture enables dynamic and impactful careers. We share a kind of DNA where we’re each
• Committed to caring
• Responsible to our communities
• Ready to apply our knowledge and know-how
• Unique in our background and experiences
• The drivers of our own success
• Passionate about doing what’s right
Make a unique mark in your career
If you want to be seen for the talent you bring to your work, be the driver of your own career, and work with others who share your passion for caring and success, then we invite you to join the Johnson & Johnson Talent Community by visiting www.careers.jnj.com
We respectively request Government Officials to identify themselves as such on application; for the purpose of the Foreign Corrupt Practices Act. If you decide to apply for the position, any personal data which you provide shall be processed by Johnson & Johnson Medical, a Johnson & Johnson company. Your personal data shall be processed for the purposes of recruitment, recruitment policy and selection.
United Kingdom-England-High Wycombe
Europe/Middle East/Africa-Netherlands, Europe/Middle East/Africa-Poland, Europe/Middle East/Africa-Belgium
Janssen Cilag Ltd. (7360)
Clinical Trial Coordination