Clinical Lead

Join to apply for the Clinical Lead role at Emerald Clinical At Emerald Clinical Trials , we are a global, full-service Contract Research Organization (CRO) with a rich heritage in the Asia-Pacific region. We advance 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. Our success is built on 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 Lead is responsible for management and coordination of all clinical study management activities for assigned studies per the contracted Scope of Work (SOW). This includes study startup activities such as site selection, study team management, and project timelines. The Clinical Lead works closely with the Project Manager (PM) and may support the sponsor, investigators, and appropriate staff in each department of Emerald Clinical as needed. The Clinical Lead will lead the clinical operation team (e.g., CRAs) to manage trials and sites and assist the PM with timelines and budget adherence for each trial. Your Responsibilities Assist in the development, implementation, and management of research studies, including the Clinical Monitoring Plan (CMP), tracking protocol deviations, and supporting tools and templates. Facilitate site selection through feasibility questionnaire process and collaborate with sponsors as outlined in the CMP. Oversee protocol administration, initiation of sites, ongoing trial progress, and site close-out. Track and manage clinical management team performance and ensure site protocol adherence. Manage monitoring visit report reviews with assigned CRAs to meet timelines and metrics. Lead the development of training materials for investigator sites and the CRA team. Assist in training data management on protocol and support CRF development, query resolution, and data lock procedures. Provide ongoing site management, interim calls, clinical question resolution, and troubleshooting. Effectively communicate protocol issues and status to all departments of Emerald Clinical, sponsors, and vendors. Prepare accurate reports for the PM or sponsor as needed. Assist the PM in developing relationships with funders or sponsors. Coordinate and participate in internal and external meetings, including Bid Defense Meetings, departmental meetings, and other business or industry meetings. Support study risk identification, management, and escalations throughout the conduct of assigned studies. Ensure all clinical activities comply with SOPs, ICH GCP, and applicable country regulatory requirements. Maintain professional relationships with external customers, investigators, and vendors. Maintain professional relationships with the internal project team, including those providing academic input. Provide clear guidance to the clinical operation team on clinical deliverables as agreed with the PM. Continue to undertake site management and monitoring if experienced on an as-needed basis. Collaborate with the assigned PM to continually assess study team resourcing needs and make adjustments as needed. Financial and Contractual Management Assist the PM to analyze monthly financial reports for clinical aspects, identify trends, and raise escalations. Ensure the PM understands all clinical finance responsibilities and follows escalation pathways. Maintain clinical aspects in utilization, revenue forecast, and recognition; identify and implement improvement strategies. Maintain gross margin across allocated projects to meet organizational goals. Review forecasts for all allocated projects and develop contingency plans to address any project slippage. Oversee pass‑through report management to ensure billing is finalized within agreed timelines. Collaborate with the PM on clinical project review reporting and accurate survey responses. Maintain a list of all scope change documentation in clinical aspects. Seek opportunities for scope expansion in clinical aspects and follow up with BD & sponsors. Data Management Ensure accurate completion and timely collection of data. Ensure data quality, accuracy, completeness, and timely data completion. Ensure complete and efficient resolution of data queries. Manage the study to ensure adherence to all protocol, SOPs, regulations, and ICH‑GCP. Ensure distribution and collection of essential documents and study materials to and from clinical sites. Customer Focus and Business Development Initiate and maintain high‑level relationships with internal and external stakeholders. Assist the PM in reviewing and contributing to scope change proposals for clinical aspects. Provide technical advice and process improvement suggestions to other areas of Emerald Clinical. Participate in bid defence presentations and lead presentations for less complex regional studies. Quality Management Ensure clinical management in allocated projects follows the Emerald Clinical Quality Management Strategy. Work with key project team members to achieve audit/inspection readiness and complete follow‑ups. Ensure compliance with file review plans and documentation as specified by sponsor and/or Emerald Clinical. Ensure co‑monitoring activities conform to sponsor and/or Emerald Clinical requirements. Act as the escalation point for all significant issues related to allocated projects. About You Educated to degree level in pharmacy, medical, nursing, biological science, or another health‑related discipline (or equivalent experience). Prior CRA experience preferred, with at least 8 years of monitoring, trial coordination, or relevant industry experience. Minimum 1‑2 years of experience as a Clinical Lead / CTM or similar role. Excellent working knowledge of ICH/GCP and applicable regulations in relevant regions. Why Join Us? Purpose‑Driven Work : Contribute to trials that genuinely improve lives, focusing on renal, cardiometabolic, and oncology therapies. Global Reach, Local Expertise : Connect with local communities, build trust, and engage meaningfully at every trial. Collaboration and Innovation : Work in a culture that values diverse perspectives and creative solutions to global health challenges. What We Offer Competitive Compensation : A tailored salary and benefits package reflecting your skills and experience. Flexibility : Hybrid or remote working arrangements, depending on location and role. Career Growth : Access to learning opportunities and a global network of scientific leaders. Employee Wellbeing : Programs and initiatives promoting work‑life balance, health, and team connection. Global Opportunities : Exposure to diverse projects and clients through an internationally reaching company. 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. Seniority level Not Applicable Employment type Other Job function Health Care Provider We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr