Study Start-Up (SSU) Lead

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 RoleWe are seeking experienced and proactive Study Start-Up (SSU) Lead to join our global team. As part of Emerald Clinical’s initiative to centralise SSU operations, this role will play a key part in driving efficient, high-quality study activation processes across multiple countries and therapeutic areas.

The SSU Lead is responsible for overseeing all aspects of study start-up activities from site identification through to site activation. This includes managing submissions, budgets, contracts, and regulatory documentation while ensuring timelines and quality standards are met.

Your Responsibilities• Lead and coordinate country-level start-up activities to meet sponsor timelines and regulatory requirements• Develop and manage study start-up plans, forecasts, and deliverables• Oversee IRB/EC and hospital submissions, amendments, and issue resolution• Negotiate investigator budgets and contracts, in collaboration with the Contracts Lead• Manage essential document collection and ensure compliance with local regulations and ICH-GCP• Support global TMF readiness and document quality during start-up phase• Act as the central liaison between internal teams, sponsors, and investigative sites• Lead and support continuous improvement initiatives within the SSU functionAbout YouTo be successful in this role, you will have:

• Bachelor’s degree in life sciences or a health-related field• Minimum 5 years of clinical research experience, with 2+ years in SSU or regulatory submissions, including CTIS experience• Strong understanding of global and local regulatory requirements• Proven experience in site contract and budget negotiations• Excellent organisational and communication skills• Ability to work independently and collaborate across global teams• Experience in CRO or pharma environments strongly preferredWhy 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 OfferWe 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.