Sr. Clinical Trial Manager

Overview

Skyhawk Therapeutics seeks a Sr. Clinical Trial Manager with relevant Clinical Operations experience to join our Clinical group and provide trial management support for our Huntington’s Disease program.Responsibilities

Primary operational contact for execution of the study in compliance with ICH/GCP, Regulatory Authorities'' regulations/guidelines, and applicable SOPs/Work InstructionsDevelopment, management, maintenance of study deliverables [i.e. timelines, study plans, etc.] through collaboration with internal and external stakeholdersLead weekly meeting of the Clinical Trial Team on status of assigned studiesProactive identification of potential risks and development/implementation of actions to avoid or mitigateOperational input into study documents such as synopsis, protocol, Informed Consent Forms, CRFs, CRF Completion Guidelines, Study Execution Plans, Clinical Data Review Plan, etc.Participation in clinical service provider (vendor) selection, specification development, and management/oversightDevelopment/coordination of study training for study team, investigational sites, and vendors in collaboration with medical and scientific colleaguesProactive management of issues and information sharing with key internal/external stakeholders with use of standardized reports and other mechanismsLead both an internal and external/CRO trial management team, to ensure the successful conduct of the trial in accordance with State and Federal regulations, GCP regulations, ICH guidelines, and internal SOPsManage and lead site-facing meetings, including regular PI meetings, dose escalation meetings, and Investigator MeetingsAttend study site visits, such as pre-study selection visits, site initiation visits, and PI engagement meetingsContribute to development of proactive strategy and corrective action plan to address trial issues in collaboration with cross functional teamResponsible for supporting the management, oversight (CRO) and maintenance of the Trial Master File (TMF)Requirements, Education, Experience and Skills

Bachelor’s degree, or equivalent, in a biomedical, life science or related field of studyMinimum of 5 years of progressively increasing Clinical Operations experience within the Pharma, Biotech or CRO industryGood understanding of US regulatory and compliance requirements for clinical researchSolid teamwork, organizational, interpersonal, and problem-solving skills; exercises good judgment with respect to confidential information and strategiesAbility to influence and collaborate well with colleagues and partners in a fast-paced environmentAbility and willingness to travel up to 25% of timeAbout Skyhawk

Skyhawk is committed to discovering, developing, and commercializing small molecule therapeutics that correct RNA splicing. We use our 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

Mid-Senior levelEmployment type

Full-timeJob function

Science, Administrative, and ..... full job details .....