Clinical Data Management Leader
6 days ago
Job Summary:
The Senior Manager of Clinical Data Management is responsible for overseeing the Clinical Data Management function for clinical studies across Natera's portfolio. This role will contribute to and directly manage a team of Clinical Data Managers and Specialists to support all aspects of clinical trial data management.
Key Responsibilities:
- Manage a team of Clinical Data Managers and Specialists to perform Clinical Data Management tasks across studies in Women Health, Organ Health, Early Cancer Detection, and Oncology or Clinical Trial Services Studies.
- Be 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.
- Lead and support the team in developing clinical trial data specifications, including eCRF design, user requirements, edit checks, query logic, and data validation.
- Be accountable for the quality and integrity of the clinical data within Natera's EDC and/or LIMS system and applicable data sources.
- Ensure data system compliance by following established industry guidelines (e.g. FDA).
- Oversee and participate in the analysis, preparation, and presentation of data as needed by study teams.
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.
Skills and Abilities:
- Solid knowledge of FDA regulations relevant to clinical trials and clinical trials software platforms.
- 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.
Physical Demands and Work Environment:
Duties are typically performed in an office setting. This position requires the ability to use a computer keyboard, communicate over the telephone, and read printed material. Duties may require working outside normal working hours (evenings and weekends) at times. Travel required for this position: Up to 25%.
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