- Organize, participate in, and maintain agendas and meeting minutes for all internal Clinical Development and cross-functional team meetings. Review external meeting minutes as required
- Work closely with the assigned Clinical Trial Managers to coordinate, track, and manage logistics in support of studies (e.g. review study plans, assist with eTMF reviews)
- Update and maintain internal trackers (e.g. central enrollment tracker, investigator engagement tracker, bioanalytical sample tracker) and implement updates into ad-hoc presentations and reports as required
- Maintain internal Clinical Operations study files and perform periodic reconciliations of documents to ensure all material is present and versioned correctly
- Create and maintain study personnel contact lists for all studies and KOLs by disease indication
- Assist with the review of study-related documents for clinical studies (e.g. protocol, IB, ICFs)
- Assist Senior CTA with the facilitation of important external meetings (e.g. Clinical Advisory Board meetings): outreach, scheduling, execution of CDAs and contracts, travel arrangements, presentations, agendas, and minutes
- Assist Senior CTA with bioanalytical sample tracking and management of central and third-party labs (sample shipment and analysis timelines)
- Assist Senior CTA with the review of central and third-party lab documents (e.g. Lab Manual, site flowcharts)
- Relevant education and training required; Bachelor's degree in administrative, science or medical areas of study is a plus
- Experience with oncology clinical trials is a plus
- At least 1 year of successful administrative experience in biotech/life sciences, health care or clinical study management
- Prefers to contribute as both independent, self-starter, and a collaborative team member
- Excellent organizational skills; prefers and can adapt to multiple priorities in a fast-paced and fluid work environment
- Excellent verbal and written communication skills
- Excellent computer skills, including Microsoft Office Suite: Calendar, Word, Excel, and PowerPoint are essential
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Clinical Trial Associate - Watertown, United States - Dragonfly Therapeutics, Inc.
3 weeks ago
Description
Clinical Trial AssociateDragonfly Therapeutics is seeking a highly motivated and experienced Clinical Trial Associate to provide administrative and operational support to Clinical Operations. In this role you will report to a Senior Clinical Trial Manager in Clinical Operations.
Responsibilities:
Dragonfly Therapeutics is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing therapies that use its novel multispecific antibody technology to harness the body's immune system to bring breakthrough treatments to patients. In addition to its wholly owned clinical assets, Dragonfly has a deep pipeline of wholly owned preclinical candidates discovered using its proprietary platform, as well as productive collaborations with Merck, AbbVie, Gilead and Bristol Myers Squibb in a broad range of disease areas.
Our mission is to revolutionize disease treatment by inventing natural killer cell-based therapies for vastly improved patient outcomes. We believe in a small team with a big impact.
