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Clinical Trial Manager (Multiple Positions)
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 can be located in Raritan, NJ; Titusville, NJ; Cherry Hill, NJ; Spring House, PA; Beerse, Belgium; High Wycombe, United Kingdom; Leiden, Netherlands; Breda, Netherlands; Basel, Switzerland; Warsaw, Poland; Beijing, China; Chengdu, China; Selangor, Malaysia; Taipei, Taiwan. Remote locations within the United States may be considered.
Het bedrijf / The company
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, cardiovascular and metabolism, and pulmonary hypertension. Please visit http://www.janssenrnd.com for more information.
United States-New Jersey-Raritan-
Asia Pacific-Malaysia-Selangor, Asia Pacific-China-Sichuan-Chengdu, Europe/Middle East/Africa-Switzerland-Basel-City-Basel, Asia Pacific-China-Beijing-Beijing, Asia Pacific-Malaysia-Kuala Lumpur-Kuala Lumpur, Europe/Middle East/Africa-Netherlands-North Brabant-Breda, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, North America-United States-New Jersey-Cherry Hill, Europe/Middle East/Africa-Poland-Mazowieckie-Warsaw, Asia Pacific-Taiwan-Taipei-Taipei, North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Spring House, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, Europe/Middle East/Africa-United Kingdom-England-High Wycombe
Janssen Research & Development, LLC (6084)
De functie / The role
As leader of the Study Management Team (SMT), the Clinical Trial Manager (CTM) will ensure regional/global clinical operations deliverables progress according to agree upon timelines and milestones. This includes country and site feasibility and site selection, trial set-up, study execution and trial closure and vendor set up activities as assigned by the Global Trial Leader (GTL). Support the GTL in leading related Contract Research Organization (CRO) country and site activities.
Lead the SMT, drive issue resolutions, and provide updates to all trial team members on the deliverable status.
Ensure that the SMT operates in a constant state of inspection-readiness.
Ensure required reports are generated and available for real time status tracking.
Contribute to data collection to support the site selection 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
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.
Support team by monitoring budgets and expenditures as expected by planned trial budget.
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.
Ensure creation of appropriate trial-specific training materials and requirements, making them available to the regional/site/CRO staff and delivering training as needed.
Responsible for the set-up and coordination of Investigator Meetings.
Act as the primary contact person for the local teams within Global Development.
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.
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.
Work with Bioresearch Quality and Compliance (BRQC) liaisons to ensure quality oversight of assigned trial utilizing the available tools.
Coordinate data cleaning with some supervision towards a timely and successful database lock.
Participate in Global Clinical Development Initiatives as assigned. Can act as a Subject Matter Expert.
Het profiel / Your profile
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 4 years of clinical trial management experience within the Pharmaceutical industry or Clinical Research Organization (CRO) is required.
Strong project planning/management and effective communication skills is required.
Proven track record in successfully managing various aspects of trials from start-up to database lock is required
Previous experience in coordinating global or regional teams is required.
Proven ability to foster team productivity and cohesiveness is preferred.
Effective leadership skills and ability to manage multiple stakeholders is preferred.
Ability to competently plan and oversee countries and select vendor budgeting process is required.
Strong analytical skills is preferred.
Experience with management and supervision of CROs/vendors is preferred.
This position will require up to 20% domestic and international travel.
Tenslotte ..... / Finally ....
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.