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Skyhawk Therapeutics is seeking a highly motivated and experienced Sr. CTA to provide administrative and operational support to Clinical Operations.
Responsibilities:
* Organize, participate in, and maintain agendas and meeting minutes for all internal and cross-functional team meetings. Review external meeting minutes as required.
* Work closely with our clinical consultants 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 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 with bioanalytical sample tracking and management of central and third-party labs (sample shipment and analysis timelines).
* Assist with the review of central and third-party lab documents (e.g. Lab Manual, site flowcharts).
* Assist with monitoring trip report across the program.
Education/Skills/Experience Requirements:
* Relevant education and training required; Bachelor’s degree in administrative, science or medical areas of study is a plus.
* At least 3-5 years of successful administrative experience in biotech/life sciences, health care or clinical study management (title commensurate with experience).
* 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. SharePoint and SmartSheet preferred.
* Veeva TMF working knowledge.
* Demonstrated multi-tasking and project management skills.
About Skyhawk
Skyhawk is committed to discovering, developing, and commercializing small molecule therapeutics that correct RNA splicing. We use our novel SkySTAR platform (Skyhawk Small molecule Therapeutics for Alternative splicing of RNA) to develop drug candidates directed to targets for some of the world’s most intractable diseases including cancer, neurological conditions, and other “undruggable” targets against a wide range of conditions.
Seniority level
* Seniority level
Not Applicable
Employment type
* Employment type
Full-time
Job function
* Job function
Science and Research
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