Senior Clinical Trial Manager (Contingent Worker)
CRISPR Therapeutics is a leading gene editing company focused on developing transformative gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 platform. CRISPR/Cas9 is a revolutionary gene editing technology that allows for precise, directed changes to genomic DNA. CRISPR Therapeutics has established a portfolio of therapeutic programs across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine and rare diseases. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Bayer, Vertex Pharmaceuticals and ViaCyte, Inc. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations in Boston, Massachusetts and San Francisco, California, and business offices in London, United Kingdom.
Reporting to the Senior Director, Clinical Operations, this individual will have primary responsibility for trial management within oncology indications. The successful hire will adhere to best practices ensuring rigor and high-quality execution of clinical trials from FIH through commercial marketing authorization. This person will manage cross functional relationships with internal and external stakeholders and be the clinical operations representative to the respective program clinical sub-team. This individual will be hands on with trial sites fostering relationship development with KOLs. This is a high visibility position with great impact potential.
- Responsible for managing CROs/vendors for assigned trials ensuring adherence to defined scope of work and budget
- Identify issues and implement solutions to ensure timelines are maintained
- Develop and maintain tracking tools for clinical trials including, but not limited to, site start-up status, enrollment, study and monitoring visits, sample tracking, data entry and review and action items
- Assist with the drafting of protocols, informed consent forms, study operations guidelines and other study plans
- Oversee vendors and actively participate in all UATs for vendor systems, including IRT, EDC, Central Labs, etc
- Develop trial specific training tools for site utilization
- Oversee maintenance of the eTMF
- Work with CRISPR financial management to reconcile monthly actual and forecast budgets
- Monitor and/or co-monitor clinical trial sites, if needed
- Plan, coordinate and participate as needed in advisory boards, investigator meetings and CRA trainings
- Work collaboratively with supply chain to ensure seamless delivery of drug product to clinical sites
- Develop project-specific procedures and processes
- Develop and maintain study storyboards
- Recommend and follow up on corrective actions to ensure quick resolution of deviations or quality issues
- The candidate must maintain a high standard of professionalism, and confidentiality in this role and must be able to problem solve, communicate effectively, and trouble-shoot creatively
- BS/BA/BSN - health/science
- Minimum 5-7 years' relevant industry experience including at least 3+ years of trial management experience.
- Excellent communication, writing and presentation skills
- Demonstrated ability to work independently as well as in a team environment and seek resources as necessary.
- Ability to assess complex issues and propose viable solutions
- Demonstrated ability to lead and organize team meetings
- Ability to foster effective relationships with vendors, investigators and colleagues
- Ability to contribute technical expertise to the various aspects of the clinical trial process.
- Knowledge of industry standards as applied to ICH guidelines, GCPs and the CFR
- Proficiency in study monitoring activities
- Knowledge of the infrastructure and operational characteristics of CROs and centralized services.
- Demonstrated effective time management skills
- Must be willing to travel domestically and internationally up to 15-20%
- MS or advanced degree
- 7 or more years in a Clinical Operations Management role
- Global trial management experience
- Prior Clinical Monitoring and/or CRO experience
- Knowledge of First in Human trial management
- Experience with oncology and/or transplant
- Experience with cellular therapy trial management
- Collaborative - Openness, One Team
- Undaunted - Fearless, Can-do attitude
- Results Orientation - Delivering progress toward our mission. Sense of urgency in solving problems.
- Entrepreneurial Spirit - Proactive. Ownership mindset.
CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.
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