J&J Family of Companies Senior Clinical Trial Manager in Spring House, Pennsylvania
Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Senior Clinical Trial Manager. This position can be located in Raritan, NJ; Titusville, NJ or Spring House, PA. Remote locations on the East Coast of the United States may be considered. This position requires approximately 2 days per week in-office at one of the locations listed.
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. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.
The Senior Clinical Trial Manager (Senior CTM) will be responsible for the global coordination of clinical trial management activities for internally managed and/or outsourced trials. This will include the management of global vendors involved in site facing activities such as Interactive Voice Response Systems (IVRS), Central Lab, ePRO, Imaging, Translation, Printing, Ancillary supplies and Meeting Planners. This position will lead the Study Management Team (SMT) and interface with stakeholders internal and external to Global Clinical Development Operations (GCDO) functions, such as Study Responsible Physician, Global Data Manager, Trial Supply Manager, Contract Research Organization (CRO) staff, vendor staff and Study Sites (if applicable). This individual will work closely with the GCDO Trial Leader (GTL) and will be a member of the Trial Team, led by the GTL. At the Senior level, a CTM is given assignments that are more complex and/or have a greater potential impact on business results. May act as the lead over a team of CTMs across a project/program, on insourced and outsourced studies. May lead taskforces and provide innovative input.
The Senior CTM 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 and site feasibility, site selection, trial set-up, study execution, trial closure and vendor set-up activities as assigned by the GTL. Support GTL in leading related CRO country and site activities.
Study Management Team Leader: Lead the SMT, drive issue resolutions, and provide updates to all 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.
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. Ensure the availability of robust recruitment/contingency plans are in place for each region. Ensure 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. Ensure accurate budget management for assigned trials, including the budget updates in line with scope and follow up on budget variances. Ensure that vendors and affiliate budgets are tracked according to plan, making updates to proactively account for scope changes.
Document development: Create and update 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: Ensure creation of appropriate trial-specific training materials and requirements, making them available to the regional/site/CRO staff and delivering training as needed. Manage 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. Demonstrate deep knowledge of protocol and procedures and adequate therapeutic area knowledge.
Continuous quality focus: Ensure compliance with global Health Authority (HA) regulations and guidelines, and internal operating procedures and processes. Participate in preparation for, and conduct of, HA inspections and internal audits. Ensure that the SMT operates in a constant state of inspection-readiness. Work with Bioresearch Quality and Compliance (BRQC) liaisons to ensure quality oversight of assigned trial utilizing the available tools.
Data cleaning: Coordinate data cleaning independently towards a timely and successful database lock.
A minimum of a Bachelor’s degree or equivalent is required, preferably in Life Sciences (e.g. Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
A minimum of 8 years of clinical trial management experience within the Pharmaceutical industry or Clinical Research Organization (CRO) is required.
A minimum of 2 years of experience coordinating global teams in a virtual environment is required.
Experience successfully managing trials globally (across continents) and leading country teams from start-up to database lock is highly preferred.
Knowledge of clinical research operations is required.
Clinical trial monitoring experience is preferred.
Experience with data management and/or central monitoring is preferred.
Experience with the management and supervision of CROs/vendors required.
Project planning/management experience is required.
Experience with proactive planning, risk mitigating and gaining team consensus on updated plans during the project lifecycle is required.
Financial/budget management experience is required.
Proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook) is required.
Must have excellent communication and presentation skills.
Must have strong leadership and delegation skills.
Must have strong analytical skills.
The ability to independently manage multiple stakeholders is required.
The ability to collaborate with all levels and influence decision-making in a global, matrix environment is required.
This position will require up to 20% domestic and international travel.
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 veteran status and will not be discriminated against on the basis of disability.
United States-New Jersey-Titusville-
North America-United States-New Jersey-Raritan, North America-United States-Pennsylvania-Spring House
Janssen Research & Development, LLC. (6084)
Clinical Trial Coordination