Regional Clinical Study Manager

This is a fully remote position, open to applicants in Malaysia.

📋 Description

• Responsible for delivering regional studies with a focus on inspection readiness quality, within established timelines and budget constraints.

• Serve as the regional lead for various studies across a specific indication or program.

• Oversee the regional clinical operations team and external regional partners.

• Act as the point of escalation for regional study-related issues.

• Ensure that regional deliverables are in line with the overall objectives of the study.

• Develop regional tools, work instructions, and Standard Operating Procedures (SOPs).

• Lead the planning and management of assigned clinical studies from feasibility assessments through to closeout.

• Manage timelines for study start-up and recruitment, while tracking progress.

• Facilitate trial feasibility, country allocation, and site selection processes.

• Coordinate local adaptations of global study documents and handle regulatory/ethics submissions.

• Maintain updated regional and country information in study systems.

• Collaborate with Clinical Research Associates (CRAs) to ensure effective study execution and review monitoring reports.

• Ensure the creation, maintenance, and quality control of Trial Master Files at country and site levels.

• Provide insights on regional drug inventories, labeling, regulatory approvals, and comparator reimbursement statuses.

• Oversee regional trial data collection, data entry, and resolution of queries.

• Assist in the planning and execution of Clinical Study Reports.

• Monitor regional adherence to protocols, SOPs, ICH/GCP, and relevant regulations.

• Ensure readiness for inspections and prepare sites for audits.

• Drive responses to audit and inspection findings.

• Lead process enhancements and the development/review of work instructions and SOPs.

• Select and manage regional study vendors.

• Oversee regional study budgets and manage investigator/site payment activities.

• Identify regional resource needs and monitor the effective use of resources.

• Provide performance feedback, mentor junior team members, and may take on line management responsibilities.

⛳️ Requirements

• A Bachelor’s Degree in a scientific or healthcare discipline is required.

• Exceptions may be considered for candidates with relevant clinical operations experience.

• A minimum of 6 years of progressive experience in clinical research within the biotech, pharmaceutical, or CRO industries.

• Demonstrated experience in clinical research, including relevant roles as a team lead in clinical functions.

• Experience as a Clinical Research Associate (CRA) is preferred.

• Proficiency in MS Office applications.

• Proficiency in project planning applications.

• Travel may be required based on business needs.

🏝️ Benefits

• Competitive compensation package that includes a performance-based annual bonus scheme.

• Company shares offered (generous welcome grant!).

• Opportunities for in-house and external learning and development.

• Comprehensive benefits program.

• A dynamic, collaborative, supportive, inclusive, and enjoyable team environment.