Johnson & Johnson Careers
Clinical Trial Manager
Beijing, China; Beijing, China; Chengdu, China; Shanghai, China; Shenyang, China; Tianjin, China; Nanjing (Nanking), China; Xi'an, China; Hangzhou, China; Guangzhou (Canton), China
Clinical Trial Coordination
Requisition ID: 1805682509W
• 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.
Manage timely and accurate documentation, communication of study progress and issue escalation.
• 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. Ensures 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.
• 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.
• 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. 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.
• Ensures 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 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.
• 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.
• Coordinate data cleaning with some supervision towards a timely and successful database lock.
• BS degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)
• Minimum of 4 years clinical operations experience in the pharmaceutical industry or CRO.
• Required Knowledge, Skills and Abilities (Uncompromised requirements for the role): Requires clinical research operational knowledge, strong project planning/management and effective communication skills. Experience and ability in coordinating global or regional teams in a virtual environment. Proven track record in successfully managing various aspects of trials from start-up to database lock. Monitoring experience is recommended or other relevant experience should be considered, such as data management or central monitoring.
• Effective leadership skills and ability to manage multiple stakeholders. Strong analytical skills. Effective verbal and written communication skills leading to successful team collaboration.
• Demonstrated experience in presenting to stakeholders. Proven ability to foster team productivity and cohesiveness. Strong decision making. Solution oriented. Ability to understand and 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. Strong knowledge of standard Microsoft applications, willingness to learn new systems.
• Experience with management and supervision of CROs/vendors is preferred.
• Specific Therapeutic Area experience may be required depending on the position. Experience with planning tools is an asset.
China-Beijing-Beijing, China-Sichuan-Chengdu, China-Shanghai-Shanghai, China-Liaoning-Shenyang, China-Tianjin-Tianjin, China-Jiangsu-Nanjing (Nanking), China-Shaanxi-Xi'an, China-Zhejiang-Hangzhou, China-Guangdong-Guangzhou (Canton)
J&J (China) Investments Ltd A- Beijing Branch (7075)
Clinical Trial Coordination