Clinical/Regulatory Systems Manager, IT

Cambridge, MA, United States
Oct 18, 2020
Required Education
Bachelors Degree
Position Type
Full time
Our mission:

Developing curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.

At Intellia, we are committed to solving the complex challenges of making CRISPR/Cas9-based medicines a reality for patients suffering from genetic diseases and to create novel engineered cell therapies for immuno-oncological and autoimmune diseases.

The Clinical/Regulatory Systems Manager will support the identification, selection, and implementation activities associated with Clinical Systems. This manager will work closely with the Clinical/Regulatory Group. Work with a team to define requirements, identify and implement solutions to address areas of improvement within the Clinical/ Regulatory systems space. This role also includes supporting stakeholders to drive adoption, identify and resolve usability issues. Requires experience leading workshops to gather business requirements and implement technology solutions. Strong ability to clearly communicate with non-technical business users. Participate in functional requirement gathering and design review meetings. Manage and execute User Acceptance Test (UAT) scripts.

    • Maintain and administer Clinical/ Regulatory systems as needed.
    • Provide analysis in support of process improvement of Clinical Systems.
    • Participate in regulatory systems analysis and support.
    • Participate in projects to enhance clinical systems/processes.
    • Define end user requirements and support.
    • Provide oversight of user account permissions and security access controls.
    • Hands-on training support as required.
    • Collaborate with Clinical Operations system enhancements and roll out of changes/enhancements, including development of training materials/user manuals/learning solutions
    • Interact with various levels in the organization which includes IT, Quality and Clinical Operations.

    • Bachelor's degree (scientific, business or technical degree)
    • A minimum of 7 years of related work experience managing clinical systems
    • Experience working as a liaison between IT and Clinical Operations.
    • Experience with Risk Assessment
    • Experience with Regulatory processes and systems is a plus.
    • Experience with electronic systems used in clinical trials such as (EDC) IRT, Clinical Supply Chain, eTMF, CTMS).
    • Experience with user requirements analysis and system implementation.
    • Experience with Software Development Life Cycle (SDLC) and Computer System Validation (planning, overseeing, executing, documenting)
    • Understanding of regulatory and compliance needs related to clinical systems such as 21 CFR Part 11, ICH GCP guidance, GDPR, etc.


What Intellia Stands For:

We push boundaries. We are focused on positively disrupting health care treatment of patients with genomic diseases. The values we live by and drivers we look for are:

- One is respect for individuals; our unique qualities and strengths; our own ways to understand, learn and improve. One is our single-minded determination to excel; to succeed together. One is you and us - trusting and counting on every single one of us.

- Explore because we seek new ways to tackle disease. Explore with unbounded from assumptions, open to ideas. Explore by staying curious, by pushing boundaries, overcoming obstacles. Explore means thinking of new ways.

- Disrupt by thinking courageously...and creating a better future. Disrupt by defying conformity; interrogating the status quo; questioning our momentum. Disrupt with challenging thoughts...with that breed of skepticism that shows you have better solutions.

- Deliver with your focus on the objective and your determination to complete the task. Deliver by advancing relentlessly and by maintaining high standards...even when nobody is watching. Deliver by staying accountable and pulling your weight. Deliver because patients are counting on us to make the promise reality. Get it done.

POSITION: Full-Time, Exempt

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.

Intellia's web-based application process is managed through Lever. Information submitted through application forms is collected by Lever and subject to Lever's privacy policy .