Clinical Trial Manager

Description

• Manage and provide accountability for day-to-day operations of the project, as defined by the contract and according to ICH/GCP and all other applicable laws, rules, and regulations;
• Serve as primary Sponsor contact for operational project-specific issues and study deliverables;
• Maintain in depth knowledge of protocol, therapeutic area, and indication;
• Provide cross-functional oversight of internal project team members and deliverables, which includes ensuring all necessary project-specific training is provided;
• Review and provide input for study protocol, edit check specifications, data analysis plan, and final study report, when applicable;
• Develop operational project plans;
• Manage risk assessment and execution;
• Responsible for management of study vendor; and
• Manage site quality, including direct supervision of project Clinical Research Associates and monitoring deliverables.

Qualifications

• Bachelor’s degree in a health or life science-related field;
• At least two years of clinical trial management experience in Asia Pacific region ideally in a CRO environment;
• Experience in Cardiovascular, Renal, Metabolic or Gastrointestinal related studies required;
• Excellent communication skills including good written and spoken English; and
• Flexible, accountable and comfortable in working in a global environment.