Join Our Team as a Manager, Clinical Data Management at CRISPR Therapeutics

Company Overview

Since its inception over a decade ago, CRISPR Therapeutics has been at the forefront of the gene editing revolution, leveraging the Nobel Prize-winning CRISPR technology to develop transformative medicines across hemoglobinopathies, oncology, regenerative medicine, cardiovascular, and rare diseases. We are headquartered in Zug, Switzerland, with key operations in Boston, Massachusetts, San Francisco, California, and an office in London, United Kingdom. Through strategic partnerships with industry leaders such as Bayer and Vertex Pharmaceuticals, we continue to innovate and lead in our field.

Position Summary

We are seeking a dedicated Manager, Clinical Data Management to lead our data management strategy, enhancing the quality and efficiency of clinical trials at CRISPR Therapeutics. As a pivotal part of our team, you will oversee activities essential for the accumulation of high-quality and reliable clinical data across all phases of clinical development.

Key Responsibilities

- Lead data management tasks and set timelines, managing relationships with Contract Research Organizations (CROs), third-party data vendors, and Electronic Data Capture (EDC) vendors.

- Collaborate effectively across internal teams to meet project needs, also authoring key data management documentation.

- Oversee the creation and maintenance of databases and validate their quality and adherence to standards through User Acceptance Testing (UAT) cycles.

- Contribute to process improvements, medical coding, Serious Adverse Event (SAE) reconciliation, and readiness for Good Clinical Practice (GCP) inspections.

Minimum Qualifications

- Bachelor's degree in a health-related field; 7-10 years of clinical data management experience within a regulatory environment, or 6-8 years with an advanced degree.

- Expertise in EDC databases like Medidata Rave and familiarity with CDASH/SDTM/CDISC standards, coupled with robust knowledge in medical terminology and coding systems such as MedDRA and WHODrug.

- Proficient in maintaining a multitasking environment within a fast-paced setting, showcasing excellent problem-solving and communication abilities.

Preferred Qualifications

- Experience with R or SAS programming, global clinical trials, first-in-human to registration trials, and documentation for regulatory submissions (NDA, BLA, MAA).

- Background in rare genetic diseases, autoimmune diseases, and/or oncology.

Why CRISPR Therapeutics?

At CRISPR Therapeutics, we believe in a balanced approach to work, supporting a hybrid work model that facilitates both remote work and in-person interactions. Our commitment extends to fostering a diverse and inclusive environment where each individual’s unique background and experiences are valued.

CRISPR Therapeutics is proud to be an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Ready to make an impact? Apply now to be a part of our mission-driven team at CRISPR Therapeutics as a Manager, Clinical Data Management!