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Job Function:
R&D Operations
Job Sub Function:
Clinical Trial Project Management
Job Category:
Professional
All Job Posting Locations:
Bangkok, Bangkok, Thailand
Job Description:
Position Summary:
Local Trial Manager is a mid-level trial management role with typically at least 2 years of clinical trial management or 3-5 years for clinical monitoring experience. This role is responsible for local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries. 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 as described in GCO procedural documents. Local Trial Manager is responsible for coordinating and leading 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. Local Trial Manager actively contributes to process improvement; training and mentoring of Clinical Trial Assistants (CTA), Site Managers (SM) and Associate, Local Trial Managers. Local Trial Manager may have some site management responsibilities. Local Trial Manager may also perform the role of Trial Delivery Manager (TDM)/Trial Delivery Leader (TDL) for single country as described in GCO procedural documents.
Principal Responsibilities:
Lead country feasibility and site selection activities with FM/CRM, SM, TDM/TDL and Program Delivery Lead.
Conduct and standardize Site Qualification Visits; follow up on qualification and feasibility reports and recommend sites for selection.
Develop and/or contribute to country‑level study management documents, procedures and tools.
Plan and manage local trial operations to meet recruitment, data quality, timelines and budget targets (including contingency and risk management).
Ensure timely reporting and documentation of AEs/SAEs and Product Quality Complaints per requirements.
Maintain and update trial management systems and use study reports to monitor progress.
Initiate CAPAs and corrective actions when performance deviates from plans; communicate issues to study management.
Support vendor selection and management; review and approve local vendor and site invoices; manage local trial budget and finance reporting.
Prepare and review country and site‑specific informed consent forms; obtain and manage IEC/HA and regulatory approvals.
Support monitoring activities: review/approve monitoring visit reports, identify trends, and escalate as needed.
Organize and present at investigator and local trial team meetings; provide training and mentoring to CTAs, SMs and junior LTMs.
Act as subject matter expert for assigned protocols and maintain strong relationships with investigators, site staff and internal stakeholders.
Support audits/inspections and ensure CAPA implementation for quality findings.
Education and Experience 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 2 years of clinical trial management experience or a total of at least 5 years of clinical trial monitoring and/or clinical trial management experience. However, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
Specific therapeutic area experience may be required depending on the position. Should have a good understanding of the drug development process including GCP and local regulatory requirements.
Willingness to travel with occasional overnight stay away from home.
Minimum of 2 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 potential to be influential.
Some experience in mentoring/coaching and providing training to other LTMs, SMs and CTAs preferred. The 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. Ability to anticipate obstacles and proactively provide solutions.
May be assigned to high priority projects.
Required Skills:
Clinical Trials, Life Sciences R&D, R&D Strategy
Preferred Skills:
Business Behavior, Clinical Research and Regulations, Clinical Trial Designs, Clinical Trial Management Systems (CTMS), Clinical Trials, Communication, Give Feedback, Laboratory Operations, Medical Knowledge, Mentorship, Problem Solving, Process Oriented, Professional Ethics, Project Integration Management, Project Management, Research and Development, Research Ethics
