Sr. Clinical Trial Manager

Sr. Clinical Trial Manager

Skyhawk Therapeutics seeks a Sr. Clinical Trial Manager who is looking to work in a fast paced growth mindset organization focused on developing innovative therapies in across a broad portfolio of development candidates. Skyhawks preferred candidate will have Clinical Operations experience preferably managing and leading rare or CNS trials to join our Clinical Operations group and who will be responsible for providing trial management support and operational excellence for our Huntingtons Disease program.

Responsibilities (including but not limited to):

• Development management maintenance of study deliverables i.e. timelines study plans etc. through collaboration with internal and external stakeholders.
• Lead weekly meeting of the Clinical Trial Team on status of assigned studies.
• Proactive identification of potential risks and development/implementation of actions to avoid or mitigate
• Operational 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 Vendor and system selection (as applicable) specification development and management/oversight of key trial vendor/system deliverables.
• Development/coordination of study training for study team investigational sites and vendors in collaboration with medical and scientific colleagues.
• Proactive management of issues and information sharing with key internal/external stakeholders with use of standardized reports and other mechanisms.
• Lead cross functional deliverables across the study team internally. Ensuring timely information sharing and inclusion of relevant expertise areas to deliver trial results on time efficiently and effectively.
• Manage CRO day to day activities working directly with the CRO trial management team to ensure the successful conduct of the trial in accordance with study deliverable expectation key stakeholders and relevant State and Federal regulations GCP regulations ICH guidelines and CRO/Skyhawk SOPs.
• Manage and lead site-facing activities working closely with CRO and vendors to meet study deliverables.
• Attend study site visits such as pre-study selection visits site initiation visits and PI engagement meetings.
• Contribute to development of proactive strategy to enable timely delivery of study objectives including but not limited to enrollment projections cohort planning identification of potential challenges in study execution.
• Ensure execution of study in a GxP compliant manner by working closely with QA to develop (as applicable) corrective and preventive action plans (CAPAs) to address trial issues in collaboration with cross functional team.
• Responsible for supporting the management oversight and maintenance of the Trial Master File (TMF).

Requirements Education Experience & Skills:

• Bachelors degree or equivalent in a biomedical life science or related field of study.
• Minimum of 10 years of progressively increasing Clinical Operations experience within the pharmaceutical/biotech industry; Rare disease or CNS experience preferred.
• Good understanding of Global regulatory and ICH-GCP compliance requirements for clinical research.
• Solid teamwork organizational interpersonal and problem-solving skills.
• Can communicate effectively.
• Ability to influence and collaborate well with colleagues and partners in a fast-paced environment.
• Ability and willingness to travel up to 25% of time.

About Skyhawk

Skyhawk is committed to discovering developing and commercializing small molecule therapeutics that modify RNA expression. We use our novel SkySTAR platform (Skyhawk Small molecule Therapeutics for Alternative splicing of RNA) to develop drug candidates directed toward targets for some of the worlds most intractable diseases including neurological conditions cancer and traditionally undruggable targets.