Study Start-Up Lead

This is a fully remote position, open to applicants in Hong Kong, +2 more states.

📋 Description

• Lead and coordinate the initiation of country-level study activities to align with sponsor timelines and regulatory standards.

• Create and oversee study start-up strategies, forecasts, and deliverables.

• Supervise submissions to IRB/EC and hospitals, including amendments and issue resolution.

• Collaborate with the Contracts Lead to negotiate investigator budgets and contracts.

• Manage the collection of essential documents while ensuring adherence to local regulations and ICH-GCP guidelines.

• Assist in achieving global TMF readiness and maintaining document quality during the start-up phase.

• Serve as the primary liaison among internal teams, sponsors, and investigative sites.

• Lead and nurture continuous improvement efforts within the SSU function.

⛳️ Requirements

• Bachelor’s degree in life sciences or a related health field.

• At least 5 years of experience in clinical research.

• Minimum 2 years of experience in study start-up or regulatory submissions.

• Experience with CTIS.

• Strong knowledge of both global and local regulatory standards.

• Proven experience in negotiating site contracts and budgets.

• Exceptional organizational and communication skills.

• Capability to work independently and collaborate effectively with global teams.

• Experience in CRO or pharmaceutical environments is highly valued.

• Proficiency in Mandarin is preferred.

🏝️ Benefits

• Engaging work that impacts clinical trials in renal, cardiometabolic, and oncology therapies.

• Opportunity to collaborate with global teams and gain diverse insights.

• Competitive compensation and benefits package tailored to individual skills and experience.

• Flexible hybrid or remote working options based on location and role.

• Access to learning opportunities and a global network of scientific leaders.

• Employee wellbeing initiatives promoting work-life balance, health, and team cohesion.

• Participation in global engagement surveys.

• Recognition programs to celebrate achievements.

• Team-building activities to foster collaboration.

• Exposure to a variety of international projects and clients.