Senior Clinical Trial Manager

Why Join Intellia?

Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.

Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to excel and succeed together. We believe in the power of curiosity and pushing boundaries. We welcome challenging thoughts and imagination to develop innovative solutions. And we know that patients are counting on us to make the promise a reality, so we must maintain high standards and get it done.

We wantall ofour people to go beyond what is possible. We aren’t constrained by typical end rails, and we aren’t out to just “treat” people. We’re all in this for something more. We’re driven to cure and motivated for change. Just imagine the possibilities of what we can do together.

Senior Clinical Trial Manager

Development Operations

Director, Clinical Operations

Job Summary

As a Senior Clinical Trial Manager within the Development Operations organization, you will be a vital team member for operational excellence of study execution in cross functional collaboration with Data Management and Biostatistics, Medical, Regulatory Affairs, Clinical Pharmacology, Clinical Supply and CMC, Drug Safety, Medical Writing, Translational Medicine and Pharmacovigilance as well as other Global Development functions. You will provide day to day operational oversight and/or coordination for all aspects of clinical study execution.

Duties/Responsibilities

• Support and execute the day-to-day operations of aspects of complete clinical study(ies) from the protocol concept through the clinical study report per established project team goals and objectives in compliance with applicable GCP/ICH guidelines, regulations, SOPs and other regulatory requirements across the globe
• Develop and manage comprehensive timelines and metrics
• Participate in selection and management and oversight of external vendors including planning, executing study-specific meetings, key performance indicators and participate, as applicable, in vendor management governance
• Participate and has input in development of clinical study synopsis and protocol in conjunction with the clinical development plan
• Participate in the planning of quality assurance activities and coordinate resolution of audit findings
• Participate in the selection, training, and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function
• Lead in development of internal documents, as applicable (i.e. Informed Consent Forms, study reference manuals, newsletters, etc)
• Lead larger Phase I, II, or III clinical trials or plays a supporting role in more complex phase I, II or III clinical studies
• Lead the development of Clinical systems (e.g. EDC, CTMS, eTMF, IRT, etc.). Integral user of these systems
• Support the execution of large regional and/or global studies
• Facilitation of Quality processes and Quality Assurance interactions for assigned project(s)
• Leads the development of Clinical Study Activity Plans and budgets for assigned projects and deliver the plans as directed
• Lead the development and implementation of robust contingency, communication, and monitoring plans
• Provide field-based monitoring and site management support, as required
• Ensure integrity of final study files and documentation, including TMF, final TLFs, and final study data archival
• Ensure internal systems reflect latest study status
• Interact with clinical researchers and sites
• Management of study drug distribution and accountability processes and documentation
• Lead Study Team and Contract Research Organization (CRO) / Vendor meetings, as needed
• Solicit meeting agenda topics and drives agenda development
• Review meeting minutes and ensure team comments are incorporated after review
• Provide oversight for eTMF file management, as required
• Provide oversight for study regulatory documents, and review as required
• Support or may lead initiatives for the Clinical Operations and overarching Development organization on functional and cross functional projects
• May serve as subject matter expert (SME) in one or more areas such as development of SOPs, systems, tools, best in class standards for operational execution etc.
• Develop and manage study budget and maintain within financial goals; Responsible for study budgets up to $5M
• Liaise with internal departments to drive deliverables
• May communicate with external parties on study related matters, such as IRBs, ECs, and Competent Authorities
• Create, maintain, update and reconcile spreadsheets and study trackers to support various projects such as: (but not limited to): financial trackers, review and finalization of study team minutes, trial master file (TMF) tracking, etc
• Solicit cross functional input to create, maintain, update and/or reconcile project and timeline tracking software or spreadsheets and various summary reports to inform various project team stakeholders
• Create content for presentations and materials for functional project meetings
• Identification of potential deliverable or timeline challenges or bottlenecks; presents suggested prioritization or options
• Maintain confidentiality at all times
• Effectively communicate with study team members
• Serve as primary contact for specific vendor needs
• Participate in process improvement and quality-related initiatives associated with study execution and deliverables
• Monitor, interpret, and take action on study and vendor metrics
• Lead the design, preparation, planning, and implementation of upcoming clinical studies
• Will holistically view and contribute to departmental SOPs, policies, and guidances in a cross-program manner
  
  
  

Supervisory Responsibilities

• May have management/oversight responsibilities for clinical vendors and their project deliverables
• Oversight of study team and site training
• Mentor junior Clinical Operations staff
  
  
  

Requirements

• Excellent organizational skills and attention to detail
• Excellent time management skills with a proven ability to meet deadlines
• Strong analytical and problem-solving skills
• Ability to prioritize tasks and to delegate them when appropriate
• Proficient with Microsoft Office Suite or related software.
• Excellent knowledge of FDA regulations, ICH guidelines and Good Clinical Practice (GCP)
• High level of energy, passion for job, proactive and highly productive
• Willingness to collect and summarize data and information from a variety of resources and stakeholder team members / departments
• Must have multi-trial, Phase 1, 2 and 3, global experience (early phase development is a plus)
• Experience in multiple therapeutic areas or disease state/indications desirable, including life cycle management
• Excellent written and oral communication skills
• Team player with excellent attitude and excitement to cultivate strong cross functional relationships
• Excellent written and oral communication skills (timely, clear)
• Strong interpersonal skills that exemplify the Intellia core values
• Strong management skills, and ability to effectively lead and collaborate with both internal and external stakeholders
• Demonstrated leadership, problem solving, conflict resolution skills
  
  
  

BA/BS in related discipline; advanced degree preferred

At least 10 years of professional experience working in a clinical research environment (clinical site, CRO or biotech/pharma company) or demonstration of equivalent capability in a Clinical Operations role

Ability to sit or stand for multiple hours at a computer

Manual dexterity for keyboarding; may include repetitive movements

Covid-19 Vaccination Policy:All Intellia employees, regardless of work location, are expected to follow all applicable federal, state, and local public health regulations and guidelines, and are strongly encouraged to follow all public health recommendations, including being vaccinated for COVID-19.

EEOC Statement: Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.