Clinical Trial Manager (Contract)

Company Overview

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.

Position Summary

Reporting to the Director of Clinical Operations, this individual will have primary responsibility for trial management within in vivo, regenerative medicine, or 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.

Responsibilities

• Develop and maintain study storyboards
• Recommend and follow up on corrective actions to ensure quick resolution of deviations or quality issues
• Work collaboratively with supply chain to ensure seamless delivery of drug product to clinical sites
• Work with CRISPR financial management to reconcile monthly actual and forecast budgets
• 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
• Develop trial specific training tools for site utilization
• 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
• Plan, coordinate and participate as needed in advisory boards, investigator meetings and CRA trainings
• Identify issues and implement solutions to ensure timelines are maintained
• Responsible for managing CROs/vendors for assigned trials ensuring adherence to defined scope of work and budget
• Oversee maintenance of the eTMF
• Monitor and/or co-monitor clinical trial sites, if needed
• 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
• Develop project-specific procedures and processes

Minimum Qualifications

• Ability to foster effective relationships with vendors, investigators and colleagues
• Knowledge of industry standards as applied to ICH guidelines, GCPs and the CFR
• Excellent communication, writing and presentation skills
• Proficiency in study monitoring activities
• Demonstrated effective time management skills
• Ability to contribute technical expertise to the various aspects of the clinical trial process.
• BS/BA/BSN – health/science and 6+ 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.
• 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
• Must be willing to travel domestically and internationally up to 15-20%
• Demonstrated ability to lead and organize team meetings
• Knowledge of the infrastructure and operational characteristics of CROs and centralized services.

Preferred Qualifications

• Global trial management experience
• Effective Planning - Embedding discipline and thoroughness in our approaches.
• Prior Clinical Monitoring and/or CRO experience
• Communication and Teamwork – The ability to effectively express ideas in written and oral context. The ability to work co-operatively with others; the genuine desire to be a part of a team and contribute to organizational and team goals.
• Experience with oncology and/or transplant
• Experience with cellular therapy trial management
• Knowledge of First in Human trial management
• MS or advanced degree
• Relationship Building – Builds and maintains productive working relationships across a diverse spectrum of people.
• 5+ years in a Clinical Operations Management role
• Perseverance – Pursues tasks with energy, drive and initiative, even in the face of adversity.
• Adaptability/Flexibility – The ability to adapt to working effectively within a variety of situations; adapts enthusiastically to organizational change and to changes in job demands
• Problem Solving – The ability to understand a situation, task or problem by breaking it down into smaller pieces using a systematic approach and to identify patterns and connections between situations that are not obviously related.

Competencies

• Entrepreneurial Spirit – Proactive. Ownership mindset.
• Results Orientation – Delivering progress toward our mission. Sense of urgency in solving
• Collaborative – Openness, One Team
• Undaunted – Fearless, Can-do attitude

CRISPR Therapeutics believes in fostering a dynamic workplace that balances remote work flexibility with the benefits of in-person interactions. Our employees work at least three days on-site, creating a collaborative work environment, where we cultivate mentorship opportunities, increase cross-functional communication and offer opportunities for our employees to connect. Certain lab based and manufacturing positions are located fully on-site.

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.

To view our Privacy Statement, please click the following link: http://www.crisprtx.com/about-us/privacy-policy