Job Description

Job Responsibilities :

• Manage assigned clinical studies within a designated budget and timeline.
• Conduct CRO, Vendor and site assessment and selection; negotiating budget and contracts.
• Conduct site qualification, initiation, interim monitoring and close-out visits. Collecting and reviewing trial master documentation. Document results of visits in monitoring reports for review and finalization.
• Facilitate IRB submissions and renewals when needed.
• Oversee clinical sites, central lab, and other third parties to ensure issues are resolved timely. Motivating investigational sites to close queries and action items.
• Develop or review clinical project plans and clinical trial documentation.
• Collaborate with Regulatory to prepare FDA pre-submission and submission packages.
• Oversee the development of a clinical study database by third party, review and summarize clinical data, perform data analysis and reports.
• Oversee all study team members training to ensure accurate execution of clinical protocols.

Qualifications:

• Bachelor’s degree (or higher) in science or health-related discipline
• Minimum 3 years of clinical research experience for medical device and IVD products, specialty in respiratory diseases or STD is preferred
• Strong understanding of GCPs, ICH, and knowledge of regulatory requirements
• Well developed written and verbal communication skills demonstrated by an ability to present clear instruction/direction to teams at the same level in the organization and influence at higher levels in the organization
• Ability and willingness to travel ~10-15% of the time

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