Clinical Trial Manager

Skyhawk Therapeutics • Waltham, MA

2d • $140,000 - $200,000 • Hybrid

About The Position

Skyhawk Therapeutics seeks an experienced Clinical Trial Manager (title commensurate with experience) who is looking to work in a fast paced, growth mindset organization focused on developing innovative therapies across a broad portfolio of development candidates. Skyhawk’s preferred candidate will have Clinical Operations experience preferably supporting rare or CNS trials in a biotech/small pharma setting to join our Clinical Operations group.

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 biotech/pharma industry; Rare disease or CNS experience preferred (title commensurate with experience)
• Strong understanding of Global regulatory and ICH-GCP compliance requirements for clinical research
• Solid teamwork, organizational, interpersonal, and problem-solving skills
• Ability to influence and collaborate well with colleagues and partners in a fast-paced environment
• Proven track record (>2 years) of successful remote work in clinical operations if unable to be onsite
• Ability and willingness to travel up to 25% of time

Nice To Haves

• Rare disease or CNS experience preferred

Responsibilities

• Manage execution of the clinical study in compliance with ICH/GCP, Regulatory Authorities' regulations/guidelines, and applicable SOPs/Work Instructions
• Development, management, maintenance of study deliverables [i.e. protocols, informed consents, timelines, study plans, etc.] through collaboration with internal and external stakeholders
• Participation in Vendor and system selection (as applicable), specification development, and management/oversight of key trial vendor/system deliverables, including developing and managing to contracts and budgets
• Management of study training for study team, investigational sites, and vendors in collaboration with medical and scientific colleagues
• Contribute to 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
• Assist in managing CRO and other study vendors day-to-day activities working directly with the CRO or vendor trial management team, ensuring contracted deliverables are achieved on time and on budget
• 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 and risk management
• 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)
• Contribute to growth and development of clinical operations function via process/SOP review and process improvement initiatives

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level