Sr/ Assistant Manager (Research Compliance and Monitoring)

The Sr/Assistant Manager will assume responsibility for the institutional research governance operations within the Clinical Research & Innovation Office.

This role serves as a key contributor to maintaining high standards of research integrity and quality across clinical research activities. 

Core functions include: 

• Coordinate the review and implementation of research policies and procedures, supporting the policy lifecycle from stakeholder consultation to implementation, staying current with regulatory changes and translating requirements into practical guidance, and facilitating policy dissemination.
• Conduct compliance checks across research operations using systematic assessment approaches, identifying compliance gaps and recommending corrective measures, providing feedback to stakeholders on findings and recommendations, and supporting institutional audits and audit preparations.
• Conduct monitoring visits and review study documentation, assess protocol adherence and working with research teams to address issues, preparing reports and following up on outstanding items.
• Supporting sponsor oversight responsibilities and institutional quality management of clinical trials. Assist in ensuring compliance with sponsor obligations and regulatory requirements.
• Develop materials to enhance research quality awareness and to support a culture of research excellence through outreach activities

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, or related healthcare field

Preferred Experience and Skills

• Minimum 3-5 years in clinical research related operations, hands-on experience in study monitoring or QC/QA activities
• Demonstrated experience in policy development or process improvement initiatives
• Knowledge of quality management standards (ISO, ICH-GCP guidelines)
• Excellent written communication skills with proven ability to produce clear and well-structured policies, observations, and reports.
• Meticulous, strategic thinking and problem-solving abilities 
• Strong presentation and communication skills with stakeholders, including clinical staff, management, and auditors
• Proficient in MS Word, Excel and PowerPoint