Clinical Trial Manager (9-Month Contract)

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 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%

Preferred Qualifications

• MS or advanced degree
• Global trial management experience
• Prior Clinical Monitoring and/or CRO experience
• Knowledge of First in Human trial management
• Experience with oncology and/or cellular therapy trial management
• 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
• 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.
• Effective Planning - Embedding discipline and thoroughness in our approaches.
• Perseverance – Pursues tasks with energy, drive and initiative, even in the face of adversity.
• 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.
• Relationship Building – Builds and maintains productive working relationships across a diverse spectrum of people.

Competencies

• 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 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.

Base pay range of $90.00 - $100.00 per hour.

The hourly rate provided is the reasonable estimate for this contract position. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities.

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