Senior Manager, Site Management

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

📋 Description

• Supervise clinical monitoring activities and the performance of the CRA team to ensure adherence to ICH-GCP, local regulations, and company SOPs.

• Allocate resources for CRAs and conduct ongoing assessments of resource needs.

• Ensure that CRAs possess the necessary knowledge and skills for effective monitoring.

• Manage and address performance and quality metrics for CRAs.

• Strengthen relationships with sites.

• Review monitoring quality and resolve any issues that arise.

• Assist in the timely delivery of study/site milestones.

• Conduct assessment visits and develop strategies for resolution.

• Support site audits and inspections.

• Review and authorize expenses related to CRA activities.

• Identify opportunities for cost savings and improved efficiency.

• Provide mentorship and guidance to junior Clinical Research Managers.

• Lead and participate in strategic initiatives and task forces.

• Engage in recruiting and hiring processes, onboarding new team members.

• Assign tasks based on individual strengths and team goals.

• Conduct regular performance evaluations and offer constructive feedback.

• Assist team members in identifying and pursuing professional development opportunities.

⛳️ Requirements

• A Bachelor’s degree or higher in a scientific or healthcare field; advanced degrees are preferred.

• Proficient in Microsoft Word, Excel, PowerPoint, and Outlook.

• Fluent in both written and verbal English.

• A minimum of 7 years of industry experience in the pharmaceutical, CRO, or relevant fields.

• At least 4 years of people management or project management experience in progressive clinical research within the biotech, pharmaceutical sector, CRO industry, or relevant area is preferred.

• Comprehensive understanding of the drug development process, including expert knowledge of international standards (ICH GCP) and health authority requirements.

• Familiarity with all aspects of monitoring and trial execution, with prior experience as a CRA preferred.

• Excellent interpersonal skills, strong organizational abilities, and effective written and verbal communication skills.

• Proven experience in team leadership.

• Experience in Oncology is highly desirable.

🏝️ Benefits

• Competitive market compensation package, including a performance-based annual bonus scheme.

• Company shares with a generous welcome grant!

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

• An outstanding benefits program.