Job Description:
Company Overview
Founded over a decade ago, CRISPR Therapeutics is a leading biopharmaceutical company focused on developing transformative gene-based medicines for serious human diseases. The Company has evolved from a pioneering research-stage organization into an industry leader, marking a historic milestone with the approval of CASGEVY® (exagamglogene autotemcel [exa-cel]), the world’s first CRISPR-based therapy, approved for eligible patients with sickle cell disease and transfusion-dependent beta thalassemia. CRISPR Therapeutics is advancing a broad and diversified pipeline across hemoglobinopathies, cardiovascular, autoimmune, oncology, regenerative medicine and rare diseases. The Company continues to expand its leadership in gene editing through the development of SyNTase™ editing, a novel and proprietary gene-editing platform designed to enable precise, efficient, and scalable gene correction. To accelerate and expand its impact, CRISPR Therapeutics has established strategic collaborations with leading biopharmaceutical partners, including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California.
Position Summary
Reporting to the Associate Director of Clinical Operations, this individual will have primary responsibility for trial management within rare diseases and oncology indications. The successful hire will adhere to best practices ensuring rigor and high-quality execution of clinical trials. 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.
Responsibilities
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
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
Minimum Qualifications
BS/BA/BSN – health/science and 7+ years of professional experience working in a clinical research environment (clinical site, Clinical Research Organization, or biotech/pharma company), including 2+ years of Clinical 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…