Manager, Clinical Data Management

CRISPR Therapeutics • Boston, MA

1d • $123,000 - $133,000 • Hybrid

About The Position

The Manager of 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.

Requirements

• Bachelor’s degree in a health-related field is required, Master’s degree strongly preferred
• Minimum of 7+ years of progressive experience in clinical data management in a regulatory environment.
• Demonstrated proficiency managing the lifecycle of clinical data projects.
• Experience developing reports using J-Review, Business Objects, or other CDM reporting tools.
• Experience with EDC databases, especially Medidata Rave.
• Experience with CDASH/SDTM/CDISC standards.
• Experience working with central and specialty labs/vendors.
• Working knowledge of medical terminology and medical coding dictionaries including MedDRA and WHO.
• 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.

Nice To Haves

• Prior experience working in a small or medium-sized biotech or pharmaceutical company

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.

Benefits

• Base pay range of $123,000 to $133,000+ bonus, equity and benefits
• The range provided is CRISPR Therapeutics’ reasonable estimate of the base compensation for this role.
• The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 101-250 employees