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Clinical Trial Manager (1 of 10)
Requisition ID: 8039171222
Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Clinical Trial Manager. This position will reside in either Raritan, NJ; Titusville, NJ; Spring House, PA; Los Angeles, CA or La Jolla, CA and may include up to 20% travel.
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.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Clinical Trial Manager is responsible for the regional/global coordination of clinical trial management activities for internally managed and/or outsourced trials. 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 stakeholders internal and external to Global Clinical Development Operations (GCDO) functions, such as Study Responsible Physician, Global Data Manager, Trial Supply Manager, CRO staff, 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. The CTM can contribute to taskforces and provide innovative input. Participate in Global Clinical Development Initiatives as assigned and act as a Subject Matter Expert.
Ensure regional/global clinical operations deliverables progress per 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.
- Manages timely and accurate documentation, communication of study progress and issue escalation.
- Site selection, enrollment, monitor study progress.
o Contribute to data collection to support the site selection process
o Establish enrolment commitments and ensure actual enrolment meets projected commitments across the regions at the clinical trial level.
o Ensures the availability of robust recruitment/contingency plans are in place for each region.
o Ensures timely and accurate documentation and communication of study progress and issue escalation.
- Set-up country budgets and monitor actuals vs forecast for Out of Pocket Expenses, and review assigned vendor invoices/spend
- Supports team by monitoring budgets and expenditures as expected by planned trial budget. Ensures availability of required reports to support real time tracking of trial status according to trial plan.
- Document development
- 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.
- Provides 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
- Ensures creation of appropriate trial-specific training materials and requirements, making them available to the regional/site/CRO staff and delivering training as needed.
- 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.
- Data Cleaning
- Coordinate data cleaning with some supervision towards a timely and successful database lock
- Bachelor degree required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, and Pharmacy)
- Minimum of 4 years’ clinical operations experience in the pharmaceutical industry or CRO is required
- Clinical research operational knowledge is required
- Strong project planning/management experience is required
- Experience in coordinating global or regional teams in a virtual environment and leading successful team collaboration is preferred
- Proven experience in successfully managing various aspects of trials from start-up to database lock is preferred
- Monitoring experience or other relevant experience such as data management or central monitoring is preferred
- Strong analytical skills are required
- Demonstrated experience in presenting to stakeholders is required
- Experience with management and supervision of CROs/vendors is preferred
- Ability to understand, competently plan and have oversight of country and select vendor budgeting processes (i.e. Understand and be aware of country Out of Pockets (OOPs) and FTE cost drivers) is required
- Experience with planning tools are preferred
- Ability to work in or near Raritan, NJ; Titusville, NJ; Spring House, PA; Los Angeles, CA or La Jolla, CA is required
- Willing to travel up to 20% of time is required
United States-New Jersey-Raritan
North America-United States-Pennsylvania-Spring House, North America-United States-California-La Jolla, North America-United States-California-Los Angeles, North America-United States-New Jersey-Titusville
Janssen Research & Development, LLC. (6084)
Clinical Trial Administration