Clinical Research Manager

Position Summary

The Clinical Research Manager plays a pivotal role in leading and overseeing all clinical research activities within the organization. This position is responsible for managing a team of Clinical Research Coordinators, ensuring the smooth conduct of ongoing research projects, maintaining the highest standards of ethical and regulatory compliance, and specifically managing Institutional Ethics Committee (IEC) applications while serving as the Secretary to the IEC. The role requires strong leadership, organizational skills, and deep knowledge of Good Clinical Practice (GCP) and local regulatory requirements in Malaysia.

Key Responsibilities

Team Leadership \& Development

• Lead, supervise, mentor, and manage a team of Clinical Research Coordinators, including recruitment, onboarding, performance evaluations, and career development planning.
• Provide ongoing training, guidance, and support to team members on study protocols, GCP, regulatory requirements, and best practices in clinical research conduct.
• Foster a collaborative, high-performing team culture focused on quality, integrity, and continuous improvement.

Management of Ongoing Research Projects

• Oversee the full lifecycle of ongoing clinical research studies and trials — from initiation through close-out — ensuring adherence to study protocols, timelines, budgets, and quality standards.
• Monitor study progress, participant recruitment and retention, data quality, and safety reporting; proactively identify and resolve issues or risks.
• Coordinate effectively with Principal Investigators (PIs), sponsors, Contract Research Organizations (CROs), laboratories, and other external stakeholders to ensure seamless study execution.
• Manage study budgets, resource allocation, contracts, and financial tracking; prepare regular progress and financial reports for leadership.
• Ensure accurate and timely maintenance of study documentation, Trial Master Files (TMF), and electronic data capture systems.

Institutional Ethics Committee (IEC) Management

• Prepare, submit, and manage all Institutional Ethics Committee (IEC) / Institutional Review Board (IRB) applications, including new study submissions, protocol amendments, informed consent form updates, annual renewals, adverse event reports, and study closure notifications.
• Serve as the Secretary to the Institutional Ethics Committee (IEC), with responsibility for the efficient day-to-day running of the committee. This includes preparing meeting agendas, compiling and distributing review materials, recording accurate minutes, tracking decisions and action items, and maintaining comprehensive committee records and archives.
• Act as the primary liaison between researchers, the IEC, and regulatory bodies; communicate committee decisions clearly and ensure timely follow-up on required modifications or conditions.
• Ensure full compliance with Malaysian Good Clinical Practice (GCP) guidelines, relevant national regulations, and international ethical standards (Declaration of Helsinki, ICH-GCP).

Regulatory Compliance, Quality Assurance \& Process Improvement

• Develop, implement, update, and enforce Standard Operating Procedures (SOPs) for all clinical research activities to ensure consistency and regulatory compliance.
• Lead preparation for and host regulatory inspections, sponsor audits, and internal quality assurance reviews; manage corrective and preventive action (CAPA) processes.
• Stay current with evolving regulatory requirements in Malaysia (e.g., NPRA guidelines) and international best practices; advise the organization on necessary updates.
• Contribute to the development of new research proposals, grant applications, and strategic research planning as required.

Qualifications \& Experience

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, Medicine, or a related healthcare/scientific discipline. A Master's degree or higher in Clinical Research, Public Health, or related field is strongly preferred.
• Minimum of 5–7 years of progressive experience in clinical research, preferably with at least some years in a supervisory, team lead, or managerial capacity overseeing coordinators or research staff.
• Demonstrated hands-on experience in preparing and managing IEC/IRB submissions and, ideally, prior experience serving as Secretary or administrator to an ethics committee.
• In-depth knowledge of ICH-GCP guidelines, Declaration of Helsinki, and Malaysian regulatory framework for clinical research (including NPRA and ethics committee processes).
• Proven track record of successfully managing multiple concurrent clinical trials or research projects across different therapeutic areas.
• Strong proficiency in Microsoft Office Suite, clinical trial management systems (CTMS), electronic data capture (EDC) platforms, and document management systems.

Key Competencies \& Skills

• Exceptional leadership, people management, and team-building skills with the ability to motivate and develop staff.
• Outstanding organizational, project management, and time-management abilities; capable of handling multiple priorities under tight deadlines.
• Excellent written and verbal communication skills, including the ability to prepare clear reports, minutes, and correspondence for diverse audiences (investigators, ethics committees, regulators, sponsors).
• High attention to detail with strong analytical and problem-solving capabilities.
• High level of integrity, professionalism, and commitment to ethical conduct in research.
• Ability to work independently as well as collaboratively in a multidisciplinary team environment.

Work Location: In person