Johnson & Johnson Careers
Director, Global Clinical Trial Management
Requisition ID: 8808180803
Janssen Research & Development, L.L.C., a Johnson & Johnson company, is recruiting a Director, Global Clinical Trial Management to be located at one of our sites in the New Jersey or Pennsylvania area.
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.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Director, Global Clinical Trial Management will have responsibility of overseeing the Clinical Study activities for a unique drug development program that will be performed under a BARDA government contract. The BARDA contract is for the development of the drug as a radiation and chemical countermeasure as well as an Oncology drug for treatment of patients with Hepatocellular Carcinoma and patients with hematologic malignancies undergoing allogeneic bone marrow transplant. The position will be accountable for overseeing the external clinical service providers in the delivery of study outcomes.
The position is accountable for the successful global or regional execution of clinical trials assigned by the Functional Manager, Clinical Program Leader or Clinical Operations Head within a Therapeutic Area, within agreed timelines and budget, in alignment with all the applicable SOPs and regulatory requirements. This position leads the CRO Study Management Team (SMT) and interfaces with the correspondent Clinical Teams, Global Operations Support Center of Excellence Teams (GOS), and other Clinical Development Operations (CDO) functions, Regional Trial Coordination/Site Management (TCSM) colleagues, Study Sites (if applicable), and the Research and Development/Operating Company. Alignment of goals with organizational objectives as defined in the GCO cascades.
- Considered the study owner and leader of the SMT. Main focus is on trial management supervision, planning and coordination. As part of the End to End Process (E2E) includes trial set-up, execution, analysis and reporting (includes trial closure) and post-study activities. Measures study progress against agreed upon timelines to milestones.
- Ensure accurate budget management for assigned trials. This includes ensuring vendors and affiliate budgets are tracking according to plan. Updates are made to account for scope changes.
- Ensure enrollment commitments meet the projected enrollment across the regions at the clinical trial level, monitors patient recruitment at the global level, and ensure timely and accurate documentation and communication of study progress and issue escalation.
- 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 operate in a constant state of inspection-readiness. Work with Quality Management (QM) liaisons to ensure quality oversight of assigned trial utilizing the available tools.
- In coordination with the Clinical Program Leader, Study Responsible Physician (SRP) and/or Clinical Leader, the GTM is responsible to ensure appropriate trial-specific training to the TCSM and to the site study staff. Work with TCSM staff in the set-up and coordination of Investigator Meetings, if applicable.
- Ensure deliverables are carried out according to the trial plan. Provides updates to all SMT and appropriate Clinical Team members on the deliverable status. Ensure required reports are generated and available for real time tracking of trial status according to trial plan.
- Strong interaction with the R&D/Operating Company, GOS, Integrated Data Services (IDS), Clinical Supplies Unit (CSU), QM and external vendor groups.
- A Bachelor’s degree or equivalent is required, preferred in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)
- A minimum of 8 years of industry related clinical trials experience in the pharmaceutical industry or CRO is required
- Operational knowledge of clinical research and project planning/management skills are required
- Ability to be flexible and manage global or regional teams in a virtual environment is required
- Excellent decision-making and strong financial management skills are required
- MS Project skills are preferred
- Effective leadership skills and proven ability to foster team productivity and cohesiveness are required
- This position may require up to 25% domestic and international travel
United States-New Jersey-New Brunswick
North America-United States-New Jersey-Raritan, North America-United States-Pennsylvania-Spring House, North America-United States-New Jersey-Skillman, North America-United States-New Jersey-Titusville, North America-United States-New Jersey-New Brunswick, North America-United States-Pennsylvania-Horsham
Johnson & Johnson (6067)