Join Our Crew

Responsibilities Include

• Plan operational delivery and direction of clinical studies across designated programs, oversee cross-functional alignment, budget, and timeline from protocol generation through completion of clinical study reports
• Guide the development of clinical operations documents and procedures required to conduct clinical studies
• Serve as delegate for the Head of Clinical Operations at meetings for designated programs
• Lead and support key Clinical Operation functional excellence activities, including project management processes and Good Clinical Practices (GCPs)
• Manage clinical studies’ vendor timelines, through designated contracts or service agreements
• Identify and interpret risks, program or resource gaps and implement mitigation strategies or corrective actions to address them
• Develop and track KPIs with CROs and other vendors
• Build relationships with vendors and all program and study key stakeholders to oversee clinical study progress, develop solutions to accelerate enrollment, and expand to additional sites, as necessary
• Contribute to development of key regulatory documents such as INDs and CTAs
• Contribute to all elements of data management activities, to support timely database builds, process flows and electronic data capture from multiple clinical sites, data management and closeout for each respective study and ensure site compliance and data quality
• Ensure compliance with all company standard operating procedures (SOPs), GCP, FDA and applicable international regulations concerning clinical activities
• May require management of day-to-day study operations as needed.

Required Qualifications

• Experience with early stage (Phase I / II) clinical studies
• Experience conducting gene or cell therapy clinical trials
• Bachelor’s degree in the Life Sciences or equivalent healthcare degree with 8+ years’ industry experience in Study Management or Clinical Program Management working within a complex cross functional clinical trial execution environment
• Demonstrated experience in building and maintaining strong relationships with clinical trial sites, vendors, and associate personnel, with a strong customer-focused mindset
• Thorough knowledge and understanding of FDA and ICH Guidelines, GCP, medical terminology, and clinical trials
• Detailed understanding of all aspects of clinical protocol design, implementation, BLA/NDA submissions and overall drug development
• Proven track record demonstrating excellent clinical project management and project execution skills including clinical supply logistics and sample management
• Outstanding written communication skills including writing technical documents, such as protocols, protocol amendments, informed consent, and other trial-related documents
• Must be self-motivating, prioritize and manage a large volume of work, and show attention to detail
• Strong team orientation and passion for continuous self-development.
• Experience in industry or in a startup industrial setting is preferred.

Preferred Skills

• Experience successfully managing other clinical operations personnel
• Ability to think critically and creatively with a strong attention to detail
• Self-motivated and able to work autonomously
• Produces top-quality work with little oversight
• Demonstrated ability to juggle multiple priorities in a fast-paced environment
• Able to build strong relationships and collaborate effectively with colleagues

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