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Job Function:

R&D Operations

Job Sub Function:

Clinical Trial Support:

Job Category:

Professional

All Job Posting Locations:

Bangkok, Bangkok, Thailand

Job Description:

Principal Responsibilities

• Act as the primary local company representative for assigned clinical trial sites, ensuring strong site performance, regulatory compliance, and inspection readiness.
• Lead site feasibility activities, Site Qualification Visits (SQVs), and support Investigator Meetings (IMs), including preparation of materials and presentations as required.
• Provide end‑to‑end oversight of site execution, including start‑up, initiation, on‑site and remote monitoring, ongoing site management, and close‑out activities in accordance with ICH‑GCP, SOPs, and applicable regulatory requirements.
• Drive the implementation of risk‑based monitoring strategies and proactively manage, resolve, and escalate site‑level issues to ensure timely and effective resolution.
• Ensure continuous compliance with site staff training requirements and accuracy and completeness of training documentation across all trial phases.
• Partner closely with the Local Trial Manager and cross‑functional study teams to optimize site activation timelines and operational delivery.
• Maintain accountability for investigational product oversight, study supplies, data integrity, and timely safety reporting, including AEs, SAEs, and PQCs.
• Ensure completeness and quality of trial documentation, support audit and inspection readiness, and drive timely closure of corrective and preventive actions (CAPAs).
• Act as a subject‑matter expert for assigned protocols, contributing to mentoring, process improvement initiatives, and best‑practice sharing across sites.

Qualifications & Experience

• Bachelor’s degree in Pharmacy, Nursing, Life Sciences, Medical Sciences, or a related scientific discipline (or equivalent relevant experience).
• Minimum 4**–5 years of clinical trial monitoring or site management experience**; candidates with4–5 years of hands‑on monitoring experience are strongly preferred.
• Proven experience supporting clinical trials from site start‑up through close‑out in compliance with GCP and regulatory requirements.
• Strong working knowledge of ICH‑GCP, company SOPs, local laws and regulations, study protocols, and monitoring guidelines.
• Oncology therapeutic area experience is an advantage.
• Demonstrated ability to manage multiple trials and sites in parallel while consistently delivering high‑quality results.
• Strong communication and interpersonal skills, with the ability to effectively engage investigators, site staff, and cross‑functional teams.
• Proficient in English and the local language, with strong written and verbal communication skills.
• Strong problem‑solving abilities with the capability to work independently and manage complex site‑level challenges.
• Proficient in clinical trial systems and standard office and reporting tools.
• Willingness to travel, including occasional overnight stays, as required by the role.

Required Skills: Preferred Skills:

Business Behavior, Business English, Clinical Data Management, Clinical Trials Operations, Execution Focus, Laboratory Operations, Mentorship, Proactive Behavior, Problem Solving, Process Improvements, Project Support, Regulatory Environment, Regulatory Inspections, Research and Development, Research Ethics, Study Management, Time Management