Merck & Co., Inc. (MSD) is looking for a Senior Clinical Research Specialist to be accountable for the performance and compliance of assigned protocols and sites within Thailand. In this local-country role, you will ensure adherence to ICH/GCP, local regulations, and company policies, acting as the primary site contact throughout all phases of a clinical research study. A key part of the role is actively developing and expanding the territory by identifying and cultivating new potential sites.

What You'll Do

Develop strong site relationships and ensure continuity through all trial phases.
Perform clinical study site management and monitoring activities in compliance with ICH-GCP, SOPs, local laws, and the protocol.
Gain an in-depth understanding of the study protocol and related procedures.
Coordinate and manage tasks with other roles to achieve Site Ready status.
Participate in site selection and validation activities.
Perform remote and on-site monitoring to ensure data completeness, accuracy, and subject safety.
Conduct site visits (validation, initiation, monitoring, close-out) and record accurate reports.
Collect, review, and monitor required regulatory documentation for study start-up, maintenance, and close-out.
Communicate with Investigators and site staff on protocol conduct, recruitment, deviations, and site performance.
Identify, assess, and resolve site performance, quality, or compliance problems and escalate as needed.
Work with internal operations, finance, regulatory, pharmacovigilance, legal, and external vendors/IRBs/Regulatory Authorities.
Manage information and documentation in CTMS, eTMF, and other systems per timelines.
Contribute to CRA team knowledge as a process Subject Matter Expert (SME), buddy, or mentor.
Support and/or lead audit and inspection activities as needed.
Perform co-monitoring visits where appropriate.
Contribute to identifying and developing new potential sites per the country strategy.