Study Start-Up Lead, APAC

Emerald Clinical; Malaysia; Hybrid; MYR 225,000 - 368,000; Full time

Benefits offered by this job

Competitive compensation

Hybrid/Remote work option

Career growth

Wellbeing programs

Global opportunities

Job summary

Emerald Clinical Trials in Malaysia seeks an experienced Study Start-Up (SSU) Lead to drive efficient study activations across regions and therapeutic areas.

You will coordinate country-level start-up activities, oversee IRB submissions, amendments and issue resolution, negotiate investigator budgets, and ensure ICH-GCP compliance while collaborating with global teams and sites. This role requires strong project management, excellent communication, and the ability to work across diverse cultures.

Qualifications

• Bachelor’s degree in life sciences or health-related field.
• Minimum 5 years 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 organizational and communication skills.
• Ability to work independently and collaborate across global teams.
• Experience in CRO or pharma environments strongly preferred.
• Mandarin Fluency is preferred.

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 function

Skills

Leadership

Regulatory knowledge

Clinical research

Budget negotiation

Communication

Independent working

Mandarin

Education

Bachelor’s degree in life sciences or health-related field

Job description

Who We Are

Emerald Clinical Trials is a

Emerald Clinical Trials is a global leader in clinical research, partnering with over 160 biotech companies and 15 of the world's top 20 pharmaceutical firms. Headquartered in Singapore, we combine scientific excellence with operational expertise to deliver end-to-end clinical trial solutions across all phases, offering Phase I-IV and real-world studies.

With over 25 years of experience and a world-renowned focus in renal research, Emerald Clinical has helped drive medical breakthroughs through deep scientific insight, flawless execution, and an unwavering commitment to quality.

Global Expertise. Local Insight. Real Impact. Emerald Clinical is where science, speed, and strategy come together to transform healthcare. For over 25 years, we have led the way in clinical research, combining global reach with deep Asia-Pacific expertise and unparalleled local insight to deliver smarter trials and stronger outcomes.

Our 1000+ employees that span across Asia-Pacific, Europe, and the Americas are embedded in communities worldwide. We drive faster recruitment, deeper patient engagement, and meaningful results that move medicine forward.

About The Role

We 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.

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 function

About You

To 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 organizational and communication skills.
• Ability to work independently and collaborate across global teams.
• Experience in CRO or pharma environments strongly preferred.
• Mandarin Fluency is preferred.

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

• 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.

We are an equal-opportunity employer and encourage applications from all qualified candidates.