How you will Achieve More with Intellia:

The Manager, Clinical Data Management is an integral part of the Clinical Data Management (CDM) team. They are a vital part of the Biometrics departments and work in close partnership with other Clinical Development functions. Key responsibilities include:

• Performs CDM activities for at least one clinical trial (pivotal or complex), ensuring all milestones are met for the study’s life cycle (start-up, maintenance, and closeout).

• Oversees and manages EDC/ePRO implementation and maintenance for their trial(s), including oversight of UAT activities.

• Oversees the data review and query management activities, coordinating/executing all data deliverables throughout the life of the trial(s).

• Collaborates and supports the CDM Lead for the Program in executing the program’s goals and maintaining consistency across studies.

• May represent for the CDM function at cross-functional and external (vendors/CROs) team meetings to ensure excellence in all aspects of clinical trial data acquisition, handling, and analysis.

• Performs oversight activities of CDM vendors on their trial(s).

• Ensures the trial operates in accordance with department standards and processes. Including ensuring the electronic Trial Master File (eTMF) is maintained and reviewed for the trial(s) on an ongoing basis.

• May oversee the work of junior team members or FSPs that work on the study.

About You:

If you enjoy working in a fast-paced Biotech environment and have a combination of experience across study, program, and functional levels within CDM, then this role is for you! Do you have the following?

• 6 years of relevant work experience with a focus on clinical data management

• Experience and comfort using Medidata Rave EDC

• Knowledge of MedDRA and WHODrug coding and experience overseeing coding and SAE reconciliation activities for clinical trials

• Ability to Translate Strategic Direction into short-term goals and objectives for your trial(s)

• Ability to Inspire Innovations & Problem Solving by seeking to improve how work gets done and inspiring other team members to do the same

• Have a strong Personal Drive and the ability to Drive Performance of others

• Ability to demonstrate Managerial Influence – motivating and holding people accountable up, down, and across the organization (as well as vendors)

• Be a strong Decision-Maker – ensuring appropriate stakeholders are involved, all relevant data are considered, conclusions are made, and actions items are appropriately followed

• Excellent written and oral communication skills

• Deep understanding of drug development and the biopharmaceutical industry preferred

Meet your future team:

This role will report to the Program Lead CDM. As part of the greater Biometrics team, the CDM group will continue to expand as our clinical trial portfolio of work and associated data responsibilities increase. The CDM team members bring an extensive range of experience and knowledge to the clinical development process. As a key member of this team, you will join a group of passionate individuals who enjoy working with one another. In addition to the CDM and Biometrics teams, you will have the opportunity to be a part of the larger group of people under the CMO, which is comprised of Clinical Pharmacology, Development Operations, Drug Safety and Pharmacovigilance, Medical Affairs, R&D Medicine, and Regulatory.

Although in a virtual environment, the group and the Intellia organization has made it a priority to continue to foster a sense of community. This includes team all-hands meetings, virtual happy hours, game nights, and more! You can expect to join a hardworking, collaborative environment driven on bringing potential new therapies to patients and their families.

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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.