Clinical Trial Manager
CRISPR Therapeutics
- Boston, MA
- Permanent
- Full-time
- 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 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.
- 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
- 5+ 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
- 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.
- 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.