At Emerald Clinical Trials , we are a global, full-service Contract Research Organization (CRO) with a rich heritage in the Asia-Pacific region. We are dedicated to advancing clinical research through scientific expertise and operational excellence, supporting biopharmaceutical, medical device, and diagnostic customers across all trial phases, from registration to post-marketing. Our therapeutic expertise spans renal , cardiometabolic , and oncology —areas where we make a significant impact on improving global health. At the heart of our success is our ability to combine global reach with local knowledge. Our on-the-ground teams work closely with local communities, building trust and ensuring diverse, representative patient recruitment. By prioritizing people, we deliver better engagement, more accurate data, and faster results—bringing therapies to patients in need. About The Role As a Medical Monitor , you will play a crucial role in ensuring the safety and integrity of clinical trials. You will provide medical and scientific expertise to clinical research projects, working closely with cross-functional teams to support study execution and compliance with regulatory requirements. This position is fully remote within the APAC region. Your Responsibilities Provide medical oversight for clinical trials, ensuring patient safety and adherence to protocol. Serve as the primary medical contact for study teams, investigators, and sponsors. Review and assess adverse events, serious adverse events (SAEs), and safety reports. Contribute to protocol development, study design, and medical monitoring plans. Participate in investigator meetings, site initiation visits, and data monitoring activities. Support regulatory submissions by providing expert medical input. Collaborate with clinical operations, biostatistics, and regulatory teams to drive successful trial outcomes. About You Medical Doctor (MD) qualification is required. At least 5 years of experience as a Medical Monitor in clinical trials. Strong knowledge of GCP, ICH guidelines, and regulatory requirements in the APAC region. Experience in safety monitoring, adverse event assessments, and medical data review. Excellent communication and collaboration skills to work effectively with global teams. Ability to provide strategic medical insights and problem-solving expertise. Why Join Us? At our core, Emerald Clinical Trials is committed to transforming clinical research by putting people first—both patients and our employees. By joining our team, you’ll be part of a global network of passionate professionals working together to deliver better research and outcomes for millions worldwide. Here’s What Makes Us Stand Out Purpose-Driven Work: You’ll contribute to clinical trials that genuinely improve lives, with a focus on therapies in renal, cardiometabolic, and oncology. Global Reach, Local Expertise: Our teams connect with local communities, building trust and meaningful engagement for every trial. Collaboration and Innovation: Work in a culture that values diverse perspectives and creative solutions to solve global health challenges. What We Offer We understand that great work happens when people feel valued and supported. That’s why we provide: Competitive Compensation: A tailored salary and benefits package to reflect your skills and experience. Flexibility: Enjoy hybrid or remote working arrangements, depending on your location and role. Career Growth: Access to a wealth of learning opportunities and a global network of scientific leaders to help you grow and develop in your role. Employee Wellbeing: Participate in programs and initiatives designed to promote work-life balance, health, and team connection, including global engagement surveys, recognition programs, and team-building events. Global Opportunities: Be part of a company with international reach, offering you exposure to diverse projects and clients. Interested? Apply now and help us achieve our mission to improve the health of millions worldwide. We are an equal-opportunity employer and encourage applications from all qualified candidates
At Emerald Clinical Trials , we are a global, full-service Contract Research Organization (CRO) with a rich heritage in the Asia-Pacific region. We are dedicated to advancing clinical research through scientific expertise and operational excellence, supporting biopharmaceutical, medical device, and diagnostic customers across all trial phases, from registration to post-marketing. Our therapeutic expertise spans renal , cardiometabolic , and oncology —areas where we make a significant impact on improving global health. At the heart of our success is our ability to combine global reach with local knowledge. Our on-the-ground teams work closely with local communities, building trust and ensuring diverse, representative patient recruitment. By prioritizing people, we deliver better engagement, more accurate data, and faster results—bringing therapies to patients in need. About The Role The Clinical Trial Specialist (CTS) is a member of the Clinical Operations team responsible for supporting clinical trial activities as the in-house site start-up and maintenance specialist. As part of the clinical trial project team, the CTS is responsible for ensuring clinical trials are conducted according to Federal Regulations, ICH guidelines, appropriate project plans, IRB/Ethic Committee requirements, and applicable SOPs and guidelines. They support the project manager, clinical trial manager and clinical operations management related to the project startup, maintenance, and close-out activities in specified administrative functions including Trial Master File set-up and maintenance. Your Responsibilities Increase proficiency in Trial Master File (TMF) set-up and maintenance (filing), both hard copy and electronic as assigned by project Increase proficiency in uploading and maintaining TMF files and folders in George Clinical’s file-sharing system by project as assigned Serve as second reviewer for TMF QC May function in the TMF Lead Role and assume responsibility for TMF setup, maintenance and oversight Assist with/complete end of study TMF filing (including site close out documents), QC and archival Further develop skills in preparing and participating in audit responses Perform QC of work (documents, emails etc.) prior to sending out to ensure quality product deliverables Further develop skills and knowledge of data entry and maintaining files/folders for Clinical Trial Management System by project as assigned Further develop skills and knowledge of assisting with data entry support, tracking and submission for investigator payments by project as assigned. Works with CRA/CTM/PM during site start-up for feasibility, serving as point of contact for sites where applicable Assist with presenting final feasibility results to PM team and/or Sponsor Assists the sites in preparation, planning, organizing and collecting essential document packets (EDPs) Submit final EDPs to sponsor or CTM/PM as required Supports site staff in the submission to Local IRBs/ECs and performs review of ICFs (initial and updated) Supports site staff in the submission to Central IRBs/ECs, performs review of ICFs (initial and updated) and submits on behalf of sites (if applicable) About You 2- 3 years' experience as CTS is mandatory Tertiary qualifications in a related science or health care discipline is preferred Exposure to medical terminology and physiology preferred Exposure to ICH/GCP, ethical and regulatory requirement Why Join Us? At our core, Emerald Clinical Trials is committed to transforming clinical research by putting people first—both patients and our employees. By joining our team, you’ll be part of a global network of passionate professionals working together to deliver better research and outcomes for millions worldwide. Here’s What Makes Us Stand Out Purpose-Driven Work: You’ll contribute to clinical trials that genuinely improve lives, with a focus on therapies in renal, cardiometabolic, and oncology. Global Reach, Local Expertise: Our teams connect with local communities, building trust and meaningful engagement for every trial. Collaboration and Innovation: Work in a culture that values diverse perspectives and creative solutions to solve global health challenges. What We Offer We understand that great work happens when people feel valued and supported. That’s why we provide: Competitive Compensation: A tailored salary and benefits package to reflect your skills and experience. Flexibility: Enjoy hybrid or remote working arrangements, depending on your location and role. Career Growth: Access to a wealth of learning opportunities and a global network of scientific leaders to help you grow and develop in your role. Employee Wellbeing: Participate in programs and initiatives designed to promote work-life balance, health, and team connection, including global engagement surveys, recognition programs, and team-building events. Global Opportunities: Be part of a company with international reach, offering you exposure to diverse projects and clients. Interested? Apply now and help us achieve our mission to improve the health of millions worldwide. We are an equal-opportunity employer and encourage applications from all qualified candidates