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About the Role

This role is responsible for the local management of a clinical trial or Medical Affairs data generation activity in a country or countries. The Lead, Local Trial Manager is the primary point of contact at a country level for assigned studies and has operational oversight of assigned protocol(s) from start-up through to database lock and closeout activities. The role coordinates and leads the local trial team to deliver quality data and trial documents/records that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements. The Lead, Local Trial Manager actively leads or contributes to process improvement, training, and mentoring of other LTMs and Site Managers. This role is often assigned to more complex protocols and can work across Phase 1 – 3 studies in multiple therapeutic areas.

Responsibilities

Lead country protocol feasibility and site feasibility assessment.
Implement local criteria for site selection and ensure consistent conduct of Site Qualification Visits.
Collaborate to select the final site list.
Contribute input to or initiate development of study management documents at a country level.
Lead and coordinate local trial team activities in compliance with SOPs, procedural documents, and applicable regulations.
Lead local project planning activities to meet recruitment targets and deliver high-quality data on time and within study budget.
Ensure all Adverse Events (AE)/Serious Adverse Events (SAEs)/Product Quality Complaints (PQCs) are reported within required timelines.
Maintain and update trial management systems and analyze trial progress using study tools.
Monitor country progress and initiate corrective and preventive actions (CAPA) when deviations occur.
Submit requests for vendor services and support vendor selection.
Assist in negotiation of trial site contracts and budgets.
Forecast and manage country/local trial budget.
Attend/participate in Investigator Meetings and may schedule/conduct local/country investigator meetings.
Conduct local trial team meetings and provide or facilitate Site Manager training.
Review and approve Monitoring Visit Reports submitted by Site Managers.
Review and approve site and local vendor invoices.
Manage local study supply.
Prepare country-specific informed consent forms.
Review and manage site-specific informed consent forms.
Organize and ensure IEC/HA approvals and compliance with local regulatory requirements.
Work with Site Managers to ensure CAPA is implemented for audits and inspections.
Comply with relevant training requirements.
Act as a subject matter expert for assigned protocols and develop strong therapeutic knowledge.
Act as primary local/country contact for a trial.
Establish and maintain excellent working relationships with external and internal stakeholders.
Actively lead or contribute to process improvement, training, and mentoring of CTAs, SMs, and other LTMs.
Conduct accompanied site visits with Site Managers.
Assume additional responsibilities or special initiatives.
Represent functional area or lead country, regional, and global process initiatives.

Requirements

A minimum of a BA or BS degree in Pharmacy, Nursing, Life Sciences, or related scientific field (or equivalent experience) is required.
Minimum of 6 years of clinical trial management experience or a total of at least 8 years of clinical trial monitoring and/or clinical trial management experience.
Specific therapeutic area experience is required and essential, particularly for key therapeutic areas.
In-depth understanding of the drug development process including GCP and local regulatory requirements.
Willingness to travel with occasional overnight stay away from home.
Minimum of 4 years of leadership experience.
Computer skills required.
Proficient in speaking and writing the country language and English language.
Excellent written and oral communication skills.
Demonstrated ability to be consistently influential.
Strong experience in mentoring/coaching and providing training to other LTMs, SMs and CTAs.
Demonstrated ability to lead initiative/small teams.
Flexible mindset and ability to work in a fast-changing environment.
Ability to work on multiple trials in parallel in different disease areas, if required.
Ability to anticipate obstacles and proactively provide solutions.
Expected to be assigned to high priority and high complexity projects.
Oncology experience required (Internal applicants: Oncology experience is not required).

Skills

Analytical Reasoning
Clinical Research and Regulations
Clinical Trial Designs
Clinical Trial Management Systems (CTMS)
Clinical Trials
Communication
Data Savvy
Laboratory Operations
Organizing
Problem Solving
Productivity Planning
Professional Ethics
Project Integration Management
Quality Assurance (QA)
Regulatory Compliance
Research and Development
Research Ethics
Standard Operating Procedure (SOP)

Location

Chiyoda, Tokyo, Japan

Work Type

Full-time

Experience Level

Senior
Lead

Education Level

Bachelor's Degree

About the Company

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

Equal Opportunity

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.