Senior Lead Clinical Research Associate, Research Compliance Management

KK Women's & Children's Hospital; Singapore; On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Senior Lead Clinical Research Associate to ensure compliance in clinical research across multiple institutions. This role involves overseeing regulatory adherence, conducting monitoring visits, and providing essential training and support to new associates. The ideal candidate will bring over a decade of experience in clinical trials, showcasing strong leadership and communication skills. Join a dynamic team where your expertise will drive compliance and enhance clinical operations, making a significant impact in the healthcare sector.

Qualifications

• 10+ years of experience in clinical trials, including 4 years in a supervisory role.
• Strong leadership, analytical, and communication skills.

Responsibilities

• Oversee clinical research compliance management across institutions.
• Plan and conduct monitoring visits, prepare reports, and train staff.

Skills

Clinical Trials Monitoring

Leadership Skills

Analytical Skills

Communication Skills

Problem-Solving Skills

Organisational Skills

Interpersonal Skills

Tools

Microsoft Office

Job description

We are seeking a Senior Lead Clinical Research Associate to oversee clinical research compliance management across SingHealth institutions. In this role, you will ensure adherence to regulatory requirements including the Human Biomedical Research Act, Health Products Act, International Council for Harmonisation - Good Clinical Practice guidelines and relevant Standard Operating Procedures.

Your responsibilities will include planning and conducting monitoring visits, preparing comprehensive post-visit reports, recommending preventive and corrective measures for compliance, and ensuring resolution of findings. You will also provide administrative support to departmental operations, develop education programes, train new Clinical Research Associates, provide supervisory monitoring and chair department meetings.

Requirements:

• At least 10 years of relevant experience in clinical trials, including clinical trials monitoring with 4 years in a supervisory or management role

• Strong interpersonal, leadership and communication skills (both verbal and written)

• Demonstrated analytical, problem-solving and organisational skills

• Ability to work independently and collaboratively, with proven capability to prioritise tasks and manage competing deadlines

• Proficiency with Microsoft Office applications