Senior Manager, Clinical Data Management
Natera
Job highlights
Summary
Join Natera as a Senior Manager of Clinical Data Management and lead a team of 2-7 Clinical Data Managers/Associates. You will oversee all aspects of clinical trial data management, from development and validation to commercialization of assays. Responsibilities include team building, ensuring data quality and integrity, and compliance with FDA regulations. You will also contribute to data analysis and presentation. A Bachelor's degree and 7 years of experience in Clinical Data Management are required, along with at least 2 years of people management experience. Natera offers competitive benefits, including comprehensive medical, dental, vision, life, and disability plans, as well as free testing for employees and their families.
Requirements
- Bachelor’s degree required, life science background preferred, but equivalent industry experience acceptable
- 7 years minimum experience with roles of increasing responsibility in Clinical Data Management
- At least 2 years of people management experience
- Solid knowledge of FDA regulations relevant to clinical trials and clinical trials software platforms, such as EDCs, and eConsent
- Proficiency in Google Workspace (gSuite), MS Word, Excel and PowerPoint
- Strong interpersonal skills and communication skills (both written and oral)
- Strong leadership skills, self-motivated, adaptable to a dynamic and fast paced environment
- Ability to collaborate with the study team, cross functional team members and external collaborators
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 quality 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
- Employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire
- Must maintain a current status on Natera training requirements
- Performs other duties as assigned
Preferred Qualifications
Advanced degree and experience in a data-driven quantitative field highly preferred
Benefits
- Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents
- Natera employees and their immediate families receive free testing in addition to fertility care benefits
- Pregnancy and baby bonding leave
- 401k benefits
- Commuter benefits
- Generous employee referral program
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