Senior Clinical Trial Manager – Johnson & Johnson – Leiden

JobID = 24×0.07

The Senior Clinical Trial Manager is responsible for the global coordination of clinical trial management activities for internally run and/or outsourced trials. He or she streamlines and channels communication with the countries and ensures inclusion of the local needs during the work of the central team.At the Senior level, a CTM is given assignments that are more complex and/or have a greater potential impact on business results. A Senior CTM is responsible to deliver complex study and/or process improvement assignments that have visible impact to the business. May act as the lead over a team of CTMs across a project/program, on internally led and outsourced studies. Able to lead task forces and provide innovative input. Mentor, train, and support more junior level staff.Duties/Responsibilities: Leads the Study Management Team (SMT), drives issue resolutions, and provides updates to all Trial Team members on the deliverables. Ensures required reports are generated and available for real time tracking of trial status. Contribute to data collection to support the site selection processEstablish 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 trackingBuild 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 critical issue processes, External Service Provider Oversight Plan, Filing and Archiving Plan.Planning and coordinate Investigator MeetingsEnsures creation of appropriate trial-specific training materials and requirements, making them available to the regional/site/CRO staff and delivering training as needed. Act as the primary contact person for the local teams within GD. Establish and maintain excellent working relationships with internal partners, such as country representatives, data management leader and clinical supply unit. Demonstrates deep knowledge of protocol and procedures and adequate therapeutic area knowledgeContinuous quality focusCoordinate data cleaning activities across the SMT to facilitate timely and successful interim analyses and database locks QualificationsBS degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)Minimum of 8 years clinical trial operations experience in the pharmaceutical industry or CRO. Requires clinical research operational knowledge, strong project planning/management expertise and effective communication skills. Experience and ability in coordinating global teams in a virtual environment for a minimum of 2, preferably 3 years. Consistent track record in successfully running trials and leading country teams from start-up to database lock. Monitoring experience is recommended, or other relevant experience should be considered, such as data management or central monitoring. Effective leadership to proactively drive the SMT through key stages of trials, as well as delegation skills. Ability to independently manage multiple stakeholders. Strong analytical skills and simultaneously demonstrates the ability to manage ambiguity when limited information is available. Effective verbal and written communication skills leading to successful team collaboration. Demonstrated strong presentation skills and effective stakeholder management. Shown ability to lead a team through formation stages, up to operating as a high performing team. Proven experience in proactive planning, risk mitigating and gaining team consensus on updated plans during the project lifecycle. Independent complex decision making. Solution oriented and proactive risk identification and mitigation. Ability to adequately plan and update country and select vendor budgets. Able to proactively identify and preempt budget issues and work with key stakeholders to resolve. Solid understanding of standard Microsoft applications, willingness to learn new systems. Able to mentor less experienced staff in productive use of key systems. Must be local to one of the following locations: Raritanand Titusville, NJSpringHouse, PAHighWycombe, UKBredaand Leiden, The NetherlandsBeerse,BelgiumWarsaw, Poland Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected vete...