Remote Senior Clinical Data Manager

Summary

Join Natera as a Senior Manager of Clinical Data Management and lead the Clinical Data Management function for clinical studies across Natera's portfolio. Contribute to and directly manage a team of Clinical Data Managers and Specialists, overseeing standard Clinical Data Management tasks, developing clinical trial data specifications, and ensuring quality and integrity of clinical data.

Requirements

• Bachelor’s degree required
• Life science background preferred, but equivalent industry experience acceptable
• Advanced degree and experience in a data-driven quantitative field highly preferred
• 7 years minimum experience with roles of increasing responsibility in Clinical Data Management
• At least 2 years of people management experience

Responsibilities

• Manage a team of 2-7 Clinical Data Managers and Specialists who perform Clinical Data Management tasks across studies in Women Health, Organ Health, Early Cancer Detection, and Oncology or Clinical Trail Services Studies
• Responsible for building an effective team, including identifying, recruiting, and vetting Clinical Data Manager candidates, and for their professional development
• Be a thought leader in the Clinical Data Management domain as it applies to Natera’s unique studies
• Oversee and be accountable for the efficient and compliant performance of standard Clinical Data Management tasks, including but not limited to the implementation of EDC, developing and maintaining Data Management SOPs and related documents (Data Management Plan, Data Review Plan, Data Transfer Specification (DTS) ...etc)
• Lead and support the team in developing clinical trial data specifications, including eCRF design, user requirements, edit checks, query logic and data validation, and site training for EDC where applicable
• Be accountable for the quality and integrity of the clinical data within Natera’s EDC and/or LIMS system and applicable data sources, ensuring it is in a fit state to qualify to lock/unlock and freeze/unfreeze as appropriate for statistical review
• Ensure data system compliance by following the established industry guidelines (e.g. FDA)
• Oversee and participate in the analysis, preparation and presentation of data as needed by study teams
• Be “data literate”, exhibit the ability to interpret and give input into summary statistics and various visuals (distribution charts, bar charts) and data dashboards required by study teams

Benefits

• Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents
• Free testing in addition to fertility care benefits
• Pregnancy and baby bonding leave
• 401k benefits
• Commuter benefits