J&J Family of Companies Senior Clinical Trial Manager in High Wycombe, United Kingdom
The Senior Clinical Trial Manager is responsible for the regional/global coordination of clinical trial management activities for internally managed and/or outsourced trials within the Therapeutic Area: Infectious Diseases and Vaccines. Responsibilities also include management of global vendors involved in site facing activities such as IVRS, Central Lab, ePRO, Imaging, Translation, Printing, Ancillary supplies and Meeting Planners. This position leads the Study Management Team (SMT) and interfaces with the Global Operations Support Teams, other Global Clinical Development Operations (GCDO) functions, Study Responsible Physician and Global Clinical Operations (GCO) or CRO/vendor staff and Study Sites (if applicable). He/she works closely with the GCDO Trial Leader (GTL) and is member of the Trial Team, led by the GTL. This position can be based in Beerse (Belgium), Leiden or Breda (the Netherlands), High Wycombe (UK), or Poland.
Ensure regional/global clinical operations deliverables progress according to agreed upon timelines and milestones as leader of the Study Management Team (SMT). Support GTL in managing related CRO activities. 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.
Set-up country budgets and monitor actuals vs forecast for Out of Pocket Expenses, and review assigned vendor invoices/spend.
Establish enrolment commitments and ensure actual enrolment meets projected commitments across the regions at the clinical trial level.
Create and update study-specific documents such as Monitoring Guidelines, Informed Consent Form, 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.
Create appropriate trial-specific training materials and requirements, making them available to the GCO site study staff and delivering training as needed. Responsible for the set-up and coordination of Investigator Meetings, if applicable, in close collaboration with GCO staff as well as GTL.
Act as the primary contact person for the local teams within GCO. Establish and maintain excellent working relationships with internal stakeholders, including Local Trial Managers. Demonstrates deep knowledge of protocol and procedures and adequate therapeutic area knowledge.
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 QA audits. Ensure that the SMT operates in a constant state of inspection-readiness. Work with Quality Management (QM) liaisons to ensure quality oversight of assigned trial utilizing the available tools.
Provides updates to all SMT as well as Trial Team members on the deliverable status. Ensure 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.
Bachelor degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, and Pharmacy).
Minimum of 8 years clinical trial management experience in the pharmaceutical industry or CRO, however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility. Requires clinical research operational knowledge, strong project planning/management and excellent communication skills. Should be flexible and have experience and ability in managing global or regional teams in a virtual environment. Proven track record in successfully managing trials from start-up to database lock. Experience with supervision of CROs/vendors is preferred. By preference background and experience in GCP and ICH Guidelines.
Ability to operate with limited day to day supervision. Can act as a back-up to the GCDO Trial Leader. Coach and mentor junior staff as needed.
Independent decision-making skills are essential to this role as are analytical skills and effectiveness in seeking solutions to issues.
Effective leadership and delegation skills and proven ability to foster team productivity and cohesiveness. Computer literacy is also required.
Willing to travel up to 20% of time.
What’s in it for you…?
“Caring for the world, one person at a time…”
As an employee we consider you as our most valuable asset. We take your career seriously.
As part of a global team in an innovative environment your development is key and our day-to-day responsibility.
Through e-university, on the job training,various projects and programs, we ensure your personal growth.
Our benefits make sure we care for you and your family now and in the future.
Europe/Middle East/Africa-United Kingdom-England-High Wycombe, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Poland, Europe/Middle East/Africa-Netherlands-North Brabant-Breda
Janssen Pharmaceutica N.V. (7555)
Clinical Trial Coordination