#R-008028
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Job Function:
R&D Operations
Job Sub Function:
Clinical Trial Project Management
Job Category:
People Leader
All Job Posting Locations:
Chiyoda, Tokyo, Japan
Job Description:
Position Summary:
Manager Clinical Operations is accountable for the operational management and successful country execution of all phases of clinical trials within assigned therapeutic area(s) or specific role(s), including resource allocation, adherence to timelines and budget, compliance with relevant Standard Operating Procedures (SOPs), policies, Health Care Compliance (HCC) and local regulatory requirements. The Manager Clinical Operations supports Country Head in shaping and managing local organizational structure to ensure its optimal efficiency and demonstrates effective issue management.
This individual is responsible for line management of Local Trial Managers (LTM), Site Managers (SM), Clinical Trial Assistants (CTA) and/or other GCO staff, as required. Oversees staff performance, development, training, project assignments, workload distribution and supports issue resolution with direct reports. Ensures alignment of local goals with organizational objectives. Drives innovative solutions and process improvements for the assigned therapeutic area(s), country, and GCO/Global Development (GD) overall.
Principal Responsibilities:
This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned.
Principal Relationships:
Primary Reporting Structure: Reports to Director Clinical Operations/Director Operations TA Head, Sr Manager Clinical Operations or County Head or equivalent
Primary interfaces: LTMs, SMs, CTAs, Country Head, other Functional Managers (FM)/Clinical Research Managers (CRM), Program Delivery Leaders (PDL)/Trial Delivery Leaders (TDL), Strategic Account Leads (SAL) and supporting roles in the country.
Other Internal Interfaces: R&D/Local Operating Company staff (including Medical Affairs), departments within and outside of GCO/GD, i.e. Delivery Units (DU), Integration and Process Optimization, Integrated Data Analytics & Reporting (IDAR), BRQC, HCC, External Alliances, Contracts & Centralized Services (CCS) and others as required.
External Interfaces: Functional management of relevant vendors, Health Authorities, Ethics Committees, investigational sites, local vendors and others as required.
Education and Experience Requirements:
• Bachelor's degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
• Minimum of 5 years of clinical research experience acquired in pharmaceutical industry, CRO or investigational site.
• Effective communication and leadership skills. Ability to foster team productivity and cohesiveness.
• Effective issue resolution and ability to generate and implement contingency plans for both productivity and quality issues when required. Excellent knowledge of drug development, clinical research operations and regulatory requirements including ICH-GCP, HCC and applicable regulations. Ability to evaluate data generated from various reports and sources. Demonstrated skills in effective communication with various internal and external stakeholders (e.g. investigational sites, ethics committees, health authorities, etc.). Influential in improving the clinical research environment at a country level. Visionary leader who can shape the organizational culture to improve adoption of future state
• Experience in mentoring/coaching (line management experience desirable). Proficient in decision-making and financial management.
• Flexible mindset and ability to work in a fast-changing environment. Operates under limited supervision.
• Proficient in English language. Computer literacy. Strong interpersonal and negotiating skills. Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment. Perform activities in a timely and accurate manner.
<For Internal Applicants>