Manager, Clinical Data Management

Company Overview

Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases.

The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines.

To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Bayer and Vertex Pharmaceuticals.

CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc.

and R&D operations based in Boston, Massachusetts and San Francisco, California, and business offices in London, United Kingdom.

Position Summary

The Manager, Clinical Data Management will lead clinical data management activities in support of CRISPR studies across all stages of clinical development.

They will ensure that clinical data capture, systems and processes will ensure accurate, consistent, high quality, and complete data.

The successful candidate will provide clinical data management oversight of outsourced clinical trials including but not limited to project management, vendor management, coordination of internal reviews, and approval of deliverables.

The candidate will impact multiple clinical development programs, health authority submissions, presentations, and publications across internal and external stakeholders.

Responsibilities

• Plan, coordinate, and manage data management tasks and timelines.
• Act as primary liaison with CROs, third party data vendors, and EDC vendors.
• Collaborate with internal clinical study team to ensure all stakeholders’ needs are addressed.
• Primary author / approver for CRFs, CCGs, edit check specifications, SAE reconciliation plans, Coding plans, Data Management Plans, and third-party vendor data specifications.
• Oversee database design, production and UAT cycles, ensuring that the CRO meets the highest quality standards.
• Accountable for external data vendor documentation, management, and reconciliation.
• Contribute to departmental SOP and process development and improvement, and integration of technology.
• Perform and / or review medical coding and SAE reconciliation.
• Support internal review / QC of clinical data.
• Support GCP inspection readiness.

Minimum Qualifications

• Bachelor’s degree in a health-related field required with 7-10+ years or experience in clinical data management in a regulatory environment or 6-8+ years of clinical data management experience with an advanced degree.
• Demonstrated proficiency managing the lifecycle of clinical data projects.
• Experience developing reports using J-Review, BOXI, and / or other CDM reporting tools.
• Experience with EDC databases including Medidata Rave.
• Experience with CDASH / SDTM / CDISC standards.
• Experience working with central and specialty labs / vendors.
• Working knowledge of medical terminology and coding dictionaries including MedDRA and WHODrug.
• Familiarity with GCP, ICH and FDA requirements as applicable for Clinical Data Management.
• Ability to manage multiple initiatives and shifting priorities within a small, fast paced company environment.
• Strong analytical and problem-solving skills that meet or improve the status quo.
• Excellent interpersonal skills with the ability to work independently and collaboratively in a dynamic team environment.
• Excellent written and oral communication skills.

Preferred Qualifications

• R or SAS programming experience.
• Experience with global studies, using an outsourced CRO model.
• Experience in clinical drug development including first-in-human through registration trials.
• NDA, BLA, MAA experience.
• Experience with drug development in rare genetic diseases, autoimmunue diseases, and / or oncology.

Competencies

• Collaborative Openness, One Team
• Undaunted Fearless, Can-do attitude
• Results Orientation Delivering progress toward our mission. Sense of urgency in solving problems.
• Entrepreneurial Spirit Proactive. Ownership mindset.

CRISPR Therapeutics believes in fostering a dynamic workplace that balances remote work flexibility with the benefits of in-person interactions.

Our employees work in a hybrid-model, creating a collaborative work environment, where we cultivate mentorship opportunities, increase cross-functional communication and offer opportunities for our employees to connect.

CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.

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