Clinical Trial Manager
Genabio DiagnosticsBedford, MA, United Statesjob_description.job_card.30_days_ago
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job_description.job_card.job_descriptionBachelor’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
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 :
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Clinical Trial Manager • Bedford, MA, United States