Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Global Clinical Development Operations (GCDO) Trial Leader (GTL) Neuroscience located preferably in Spring House, PA, Raritan, NJ, Titusville, NJ, La Jolla, CA and Belgium (Beerse).
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. We pursue the most promising science, wherever it might be found.
We discover and develop innovative medical solutions to address unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Visit http://www.JanssenRnD.com to learn more.
The GTL has primary global accountability at the trial level within the GCDO organization. The GTL is accountable and provides operational expertise for the successful cross-functional delivery of assigned global clinical trial(s), within agreed timelines and budget, and in alignment with all the applicable SOPs and regulatory requirements. The GTL is accountable for oversight of external service providers, planning and execution of both internally managed and outsourced trials, with scope from draft protocol elements document (PED) to availability of the Clinical Study Report (CSR) and applicable disclosure of the trial results.
The GTL is responsible for leading the cross-functional Trial Team (including GCDO and non-GCDO members) and interfaces with all trial team members, building the trial operational plan, is responsible for External Service Provider (ESP) contracts and budget, in alignment with the organizational and the Therapeutic Area (TA) Clinical Team (CT)’s objectives. The GTL provides global operational leadership to the execution to plan and defines risk mitigation strategies and ensures implementation thereof.
The GTL maintains oversight of the trial by taking an operational leadership role in a matrix organization, while scientific leadership is provided by the Study Responsible Physician. This includes coordinating activities in the Trial Team and ensuring ad-hoc trial Working Groups are organized as needed, driving issue identification and resolution, contingency planning, and decision-making.
Principal Responsibilities include:
• Leads the cross-functional Trial Team; Proactively manages that trial deliverables and milestones are met. Identifies risks and ensures mitigation and contingencies are being initiated and followed through (including management of CAPAs).
• Accountable for delivery of global trials within agreed/projected life of trial budget. Is responsible for overall contract management, including review & approval of external service provider (ESP) contracts, change orders and ensures services are delivered per contract.
• Ensures that environmental analysis, protocol feasibility and country & site selection process is conducted within timelines. Responsible to drive the final study placement, and ensure alignment with and communication to the involved stakeholders, including TA and RTAEs.
• Develop the trial ESP strategy for his/her assigned trial in line with the overall program ESP strategy. Is accountable for oversight of all external service providers used for the trial for both in-house and outsourced studies. Is primary point of contact for the assigned Project Director/Manager from the CRO responsible for the trial.
• Ensures Trial is operationalized in compliance with global health authority regulations and guidelines and internal operating procedures and processes.
• Ensures Trial Team members have received the appropriate trial-specific training needed for their function; in collaboration with the Study Responsible Physician (SRP), the GTL ensures appropriate trial-specific training is given to Trial Team members or to the CRO. Oversee the Clinical Trial Manager (CTM) in the set-up and coordination of Investigator Meetings, if applicable.
• Responsible to ensure transparent status reporting information to relevant key stake holders in Janssen R&D.
• Ensure trial related issues (quality, timelines, budget, resources) are resolved within the function and/or within the Trial Team. Manages timely and accurate documentation of issue escalation.
• A minimum of a Bachelor’s or equivalent University degree.
• 8 or more years’ experience managing clinical trials in pharmaceutical and/or CRO.
• Clinical research operational knowledge, strong project planning/management and excellent communication skills.
• Ability to operate with limited day to day supervision.
• Proficiency in English language (both oral and written).
• Demonstrated flexibility and ability to lead global/regional teams in a virtual environment.
• Willing to travel up to 20% of time.
• Experience in Neuroscience Therapeutic Area, specifically within psychiatric trials.
• Phase III trial experience.
• Consistent record of successfully executing trials from start-up to database lock is preferred as is prior supervision of CROs/vendors.
• Independent decision-making and analytical skills.
• Solutions focused.
• Your leadership and delegation skills with ability to champion team productivity and cohesiveness is desired.
BE VITAL in your career. Be seen for the talent you bring to your work.
United States-New Jersey-Raritan
North America-United States-Pennsylvania-Spring House, North America-United States-California-La Jolla, North America-United States-New Jersey-Titusville, Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Janssen Research & Development, LLC. (6084)
Clinical Trial Coordination
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