Lead Clinical Research Associate

PSI CRO AG; Singapore; Hybrid; SGD 60,000 - 80,000; Full time

Job summary

A leading clinical research organization in Singapore is seeking a knowledgeable Lead CRA to supervise clinical trials. You will coordinate site management activities, ensure compliance with quality standards, and lead monitoring visits. Ideal candidates have over 5 years of experience in clinical project management and strong leadership skills. This hybrid role emphasizes professional development in a supportive environment.

Benefits

Ongoing learning and development

Positive work environment focused on well-being

Ownership and autonomy

Qualifications

• At least 5 years of site monitoring experience in global clinical projects as a Lead Monitor.
• Experience managing sites and CRAs in Singapore, with knowledge of regulatory guidelines.
• Experience with monitoring visits in Phases I-III, preferably in Oncology or GI.
• Proficiency in English.

Responsibilities

• Coordinate investigator/site feasibility and identification processes.
• Monitor project timelines and patient enrollment.
• Review monitoring visit reports and ensure compliance.
• Manage Monitors in query resolution.
• Ensure timely updates to study-specific and corporate tracking systems.
• Conduct training and mentorship for Monitors and site staff.

Skills

Leadership

Communication

Problem-solving

Teamwork

Planning

Multitasking

Education

Relevant educational background (MD, MPharm, RN, or Life Sciences degree)

Tools

MS Office applications

Job description

We are the company that cares – for our staff, for our clients, for our partners, and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together 3000 driven, dedicated, and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

We offer an inspiring story of a company that has grown organically from a handful of countries to a global presence. PSI is a mature company with established standards and practices, but we do not stand still. Every day presents new challenges, and you will not get bored here.

Job Description

We’re searching for a knowledgeable, team-oriented, and proactive leader to supervise the clinical aspects of full-service global projects. As a Lead CRA at PSI, you will work on the frontline of communication with project stakeholders, ensuring the successful conduct of clinical trials across various therapeutic indications. You will maintain the highest quality standards in the industry while performing and supervising study start-up, clinical monitoring, and site management activities at the country/regional level.

Office location: Science Park Drive, Singapore (Hybrid)

Responsibilities:

1. Coordinate investigator/site feasibility and identification processes, as well as study startup activities.
2. Monitor project timelines and patient enrollment, implementing corrective and preventive measures as needed.
3. Review monitoring visit reports and ensure compliance with reporting standards.
4. Manage Monitors in query resolution, including Central Monitoring observations.
5. Coordinate safety information flow and protocol/process deviation reporting.
6. Manage clinical supplies with vendors at the country and regional levels.
7. Ensure timely updates to study-specific and corporate tracking systems.
8. Act as the main communication link between Monitors, Site Management Associates, Regional Project Leads, and Project Managers.
9. Plan and conduct monitoring visits.
10. Manage project team in site contracting and payments.
11. Lead project team calls and provide status updates and reports.
12. Evaluate data integrity and compliance at country/regional levels.
13. Prepare for and participate in site audits, and coordinate resolution of audit findings.
14. Oversee CAPA development and implementation.
15. Review process deviations and manage reporting.
16. Conduct training and mentorship for Monitors and site staff.
17. Deliver training and presentations at Investigator Meetings.
18. Manage site selection, initiation, monitoring, and closeout visits.
19. Ensure subject recruitment targets and project timelines are met.
20. Oversee source data verification and manage study risks.
21. Handle Investigational Products and study supplies responsibly.
22. Review study documents and supervise document reconciliation.
23. Ensure data integrity and compliance at the site level.
24. Supervise Site Management Associates in document and sample flow.
25. Train Investigators and support regulatory submissions.

Qualifications

1. Relevant educational background (MD, MPharm, RN, or Life Sciences degree) or equivalent experience.
2. At least 5 years of site monitoring experience in global clinical projects as a Lead Monitor.
3. Experience managing sites and CRAs in Singapore, with knowledge of regulatory guidelines.
4. Experience with monitoring visits in Phases I-III, preferably in Oncology or GI.
5. Proficiency in English and MS Office applications.
6. Strong planning, multitasking, and teamwork skills.
7. Excellent communication, collaboration, and problem-solving skills.

Additional Information

Take the next step in your career and join a company that genuinely focuses on its people.

About Us

PSI is a passionate, organically grown, and award-winning full-service CRO, operating across 60 countries with over 3000 experts. We are privately owned by our founders, maintaining independence and flexibility.

Being a Part of the Team

As part of PSI, you will have ownership and autonomy, supported by a global team in a fast-paced, innovative environment. We invest in our people through ongoing learning and development, fostering a positive work environment focused on well-being and growth.

Remuneration will reflect your skills, experience, expectations, and potential contribution.