Sr. Clinical Trial Manager

Skyhawk Therapeutics•Waltham, MA

About The Position

Sr. Clinical Trial Manager Skyhawk Therapeutics seeks a Sr. Clinical Trial Manager with relevant Clinical Operations experience to join our Clinical group and who will be responsible for providing trial management support for our Huntington’s Disease program.

Requirements

Bachelor’s degree, or equivalent, in a biomedical, life science or related field of study
Minimum of 5 years of progressively increasing Clinical Operations experience within the Pharma, Biotech or CRO industry (title commensurate with experience)
Good understanding of US regulatory and compliance requirements for clinical research
Solid teamwork, organizational, interpersonal, and problem-solving skills; exercises good judgment with respect to confidential information and strategies
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.

Nice To Haves

Experience working on a Phase III trial a plus

Responsibilities

Operational contact for execution of the study in compliance with ICH/GCP, Regulatory Authorities' regulations/guidelines, and applicable SOPs/Work Instructions
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 clinical service provider (vendor) selection, specification development, and management/oversight
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 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 SOPs
Manage and lead site-facing meetings, including regular PI meetings, dose escalation meetings, and Investigator Meetings
Attend study site visits, such as pre-study selection visits, site initiation visits, and PI engagement meetings
Contribute to development of proactive strategy and corrective action plan to address trial issues in collaboration with cross functional team
Responsible for supporting the management, oversight (CRO) and maintenance of the Trial Master File (TMF)