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.

Key Accountabilities
• Coordinate the identification, feasibility assessment, and selection of investigators and
sites to undertake the trial.
• Complete all monitoring activities per the Monitoring Plan along with completing
monitoring visit reports, accurately and within the predetermined timeframe.
• Prepare, plan, organize, and conduct site evaluation visits and report on these visits to
assist in site selection.
• Prepare, submit, and/or liaise with regulatory specialist colleagues, regarding the
preparation of regulatory packages, importation/exportation requirements, and
updates of Ethics Committee packages.
• Negotiate site budgets, coordinate for site contract execution, track invoicing, and
ensure timely site payments.
• Prepare, plan, organize, and conduct site initiation visits.
• Develop and maintain appropriate monitoring tools and project-specific documents.
• Motivate and train investigators to ensure that the trial site personnel have a good
understanding of the protocol, investigational product, and requirements of the trial so
they can fulfill their obligations to conduct the trial accurately and to deadlines.
• Manage trial sites utilizing both on-site and off-site activities including:
o Verification of quality, accuracy, completion, and timeliness of data.
o Ensure complete and efficient resolution of data queries, audits, issues, and liaise
with Data Management and/or Quality colleagues, as needed.
o Adhere to the trial protocol, all applicable project-related plans, as required by the
project training matrix, and other relevant project-specific requirements.
o Adhere to ICH/GCP and other regulatory guidelines and requirements as
relevant to the trial including reporting of subject safety - adverse/serious
adverse events, protocol violations/deviations, and liaise with safety colleagues
as needed.
o Ensure targets, metrics, and quality are maintained per trial expectations.
o Identify risks associated with e.g., clinical trial design, privacy and confidentiality,
clinical trial misconduct, and take action to mitigate risk proactively and escalate
as appropriate.
• Collect, review, and approve essential documents from trial sites, to ensure quality
and compliance, and code documents for Trial Master File (TMF) filing.
• Reconcile contents of in-house TMF and site’s Investigator Site Files.
• Coordinate distribution, tracking, handling, and destruction of investigational product
and other trial supplies per site/trial requirements.

Competencies

• Maintain trial information using the clinical trial management system and any other
tracking and reporting tools for the trial.
• Support strategies to boost recruitment efforts.
• Coordinate and perform translation verification of regional language, as required or as
applicable per region.
• Perform project site close-out visits and other site activities including archiving, as
applicable.
• Mentor, coach, and train junior staff members as directed by line management.
• Perform any additional responsibilities assigned by the Line Manager and/or Project
Lead.

Display competence in the following technical areas: ethical and participant safety
considerations, site start-up management, site conduct management, risk
management, quality management, supply management, scientific concepts and
clinical research design, and issue escalation management.
• Demonstrate competence in the following business skill areas: negotiation and
conflict resolution, critical thinking, problem-solving, decision making, and strategic
thinking.
• Demonstrate solid interpersonal communication, presentation skills, and flexibility to
work well within a multi-disciplinary team both autonomously and with a wide range of
varying stakeholders.
• Possess organisational and time management skills, which include the ability to
organise and prioritize, take initiative, and follow up independently to ensure
deliverables are met on time.
• Demonstrate practical knowledge of ICH-GCP guidelines and global and local ethical
and regulatory research requirements.
• Possess an understanding of medical terminology and physiology.
• Proficient in navigating software/systems including Microsoft Office Suite along with
other project-specific management tools.

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.

About the Role

We are seeking experienced and proactive Study Start-Up (SSU) Leads 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.

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.