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Clinical Lead

hace 1 día

Southampton

At Emerald Clinical, 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. Why Join Us? At our core, Emerald Clinical 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. About the Role The Clinical Lead is responsible for management & coordination of all clinical study management activities for assigned studies per the contracted Scope of Work (SOW), study startup activities including site selection, study team management, and project timelines for Emerald Clinical. The Clinical Lead works closely with Project Leader (PL) and may support the sponsor, investigators, and appropriate staff in each department of Emerald Clinical as needed to help launch and complete the study. The Clinical Lead will lead the clinical operation team (eg. CRAs) to manage trials and sites and have responsibility for assisting the PL with timelines and budget adherence with each trial. The Clinical Lead also works closely with the PL and Clinical Trial Assistant (CTA) / Clinical Trial Specialist (CTS) during study startup to manage site feasibility and selection process. As part of the site management responsibilities, the Clinical Lead manages the CRA activities under PL's supervision, reviews trip reports and expense reports as needed, and may assist with the performance of site qualification, site initiation, co-monitoring and/or close-out visits as needed. The Clinical Lead is responsible for demonstrating professional demeanour and maintaining confidentiality in all interactions with both internal and external contacts. Your Responsibilities Clinical Management • Facilitate site selection through feasibility questionnaire process, including input or creation of feasibility questionnaire in collaboration with the sponsors as outlined in the CMP or other study plans, • Oversight of protocol administration including pre-study work, initiation of sites, ongoing progress of trial and close out of sites, including development of study specific forms, annotated reports and customizing templates, as appropriate, • Track and manage clinical management team performance, • Working with the CRAs to ensure site protocol adherence and query resolution. Team Leadership • All clinical activities must be conducted in accordance with project specific documentation, applicable SOPs, ICH GCP and applicable country regulatory requirements., • Maintain effective professional relationships with external customers, investigators and vendors., • Maintain effective professional relationships with internal project team including those providing academic input., • Provide clear guidance to clinical operation team on clinical specific deliverables as agreed with PL., • A Clinical Lead may also continue to undertake site management and monitoring, if they have had previous experience carrying out these tasks on an as needed basis., • Collaborate with the study assigned PL to continually assess study team resourcing needs and make adjustments as needed, identifying if added resources are Out of Scope (OOS) leading to a change order. Financial and Contractual Management • Assist PL to analyze monthly financial reports for clinical aspect to identify trends and reasons behind figures, escalate as required . • Ensure PL understand all clinical aspects of their project finance responsibilities and follow appropriate escalation pathways. Maintain clinical aspects in utilization, revenue forecast and recognition identify and implement strategies for improvement (if required) and escalate any significant concerns to management • Maintain gross margin across allocated projects to meet organizational goals., • Review forecasts for all allocated projects for the clinical aspect in consultation with each allocated PL as needed, during month end billing and Project Finance Analyst meetings at least. Data Management • Ensure the 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 with all protocol, SOPs, regulations &, • ICH-GCP • Ensure distribution and collection of essential documents, reports and study materials and products to and from clinical sites Customer Focus and Business Development, • Initiate and maintain high level relationships with internal and external stakeholders, including trial sponsor staff, key opinion leaders, hospitals, professional societies and associations where required., • Assist PL to review and contribute to scope change proposals for clinical aspects prior to finalisation and sponsor review, • Provide technical advice and suggestions for process improvement to other areas of Emerald Clinical as required, • May participate in bid defense presentations for clinical service in partnership with Business Development and may lead the presentation for smaller, less complex regional studies. Quality Management • Ensure the clinical management in the allocated projects are conducted in accordance with the Emerald Clinical Quality Management Strategy., • In the event of an audit and/or inspection work with key project team members to ensure inspection/audit readiness and complete follow-up for all team members, • Ensure compliance with file reviews plan and documentation as specified by Sponsor and/or Emerald Clinical, • Ensure co-monitoring activities conducted in accordance with Sponsor and/or Emerald Clinical requirements. About You Educated to degree level in pharmacy, medical, nursing, biological science, or other health-related disciplines or equivalent relevant experience. • Prior CRA experience preferred, with at least 5 years of monitoring, trial coordination or relevant industry experience, • Excellent working knowledge of, and ability to implement project activities in accordance with, ICH/GCP and all applicable regulations and guidelines in the relevant regions. Competencies • Fluent in written and spoken English, • Must have exceptional communication skills in both verbal and written form • Must have excellent organizational and time management skills, • Must be skilled in the area of delegation and task follow-up, • Must be able to prioritize multiple projects and tasks and coordinate these efforts • Must be able to work on complex projects involving various research and ancillary entities • Must be able to promote a positive customer service attitude with Sponsors and maintain positive working relationships with internal and external staff (team player), • Must maintain overall professionalism. Additional requirements • Experience working across multiple therapeutic areas. • Ability and willingness to travel domestically & globally (up to 25%, as require. 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.

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