Clinical Trial Manager II, Clinical Operations
2 months ago
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.
How You Will Achieve More With Intellia:
Be part of a cutting-edge Clinical Operations team where we are working to get approval for curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.
Key Responsibilities:
Provide/assists with oversight for all phases of clinical trial activities (feasibility, start-up, maintenance and close-out).Leads in development of internal and study related documents, as applicable (i.e. Informed Consent Forms, study reference manuals, newsletters, etc.).Leads larger Phase Ia, Ib, or II clinical trials or plays a supporting role in more complex phase I, II, or III clinical studies with mentorship and oversight until competence for tasks is established.Oversight of study team and site training.Facilitation and oversight of quality processes for assigned project(s) including working with cross functional team members (e.g., Regulatory, Quality Assurance, etc.).Primary reviewer or provides oversight for study regulatory documents.Leads the development and implementation of program and study required plans and support financial requirements for assigned projects and executes study activities while supporting study timelines.Leads the development and implementation of robust contingency, communication, and monitoring plans.Provides field-based monitoring and site management support, as required.Ensures integrity of final study files and documentation, including eTMF, final TLFs, and final study data archival.Ensures internal systems reflect latest study status.Interacts with clinical researchers and sites.Management of study drug distribution and accountability processes and documentation.Leads Study Team and Contract Research Organization (CRO) / Vendor meetings, as needed.Solicit meeting agenda topics and drives agenda development.Reviews meeting minutes and approve for accuracy of information.Provide oversight for study regulatory documents, and review as required.Mentor and support study or department training activities for Development Operations staff.Support or may lead initiatives for the Clinical Operations and overarching Development Operations organization on functional and cross functional projects.Organizes, prepares reports, prioritizes and summarizes materials, and information for projects, per scheduled and ad hoc meeting requests.Creates, maintains, updates and reconciles 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.Solicits 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 deliverables or timeline challenges or bottlenecks; presents suggested prioritization or options.Maintains confidentiality at all times.Effectively communicates with study team members.Serves as primary contact for specific vendor to support study / program requirements.Participates in process improvement and quality-related initiatives associated with study execution and deliverables.Monitor, interpret, and take action on study and vendor metrics.Leads the design, preparation, planning, and implementation of upcoming clinical studies.May contribute to departmental SOPs, policies, and guidances in a cross-program manner.About You:BA/BS degree preferred with 8 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.Strong knowledge of FDA regulations, ICH guidelines and Good Clinical Practice (GCP).High level of energy, passion for job, creative problem solver, proactive and highly productive.Willingness to collect and summarize data and information from a variety of resources and stakeholder team members / departments.Must have strong computer skills working with Microsoft office programs (Word, Excel, PowerPoint, Outlook and Microsoft Project).Outstanding organizational 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.Physical RequirementsAbility to sit or stand for multiple hours at a computer.Manual dexterity for keyboarding; may include repetitive movements. #LI-KO2 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.-
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