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 project-specific issues and study deliverables
Maintain in depth knowledge of protocol, therapeutic area, and indication
Provide cross-functional oversight of 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 mitigations
Manage study vendors
Manage site quality, including direct supervision of project Clinical Research Associates (CRA) and monitoring deliverables
Qualifications
Bachelor’s degree or above in health/life science related field;
At least two years of clinical trial management experience in the Asia Pacific region; indications of interest a plus
Prior CRO experience is preferred
Excellent communication skills including good verbal and written English; and
Flexible, accountable, and comfortable working in a global environment.
