Manager, Data Management
Manager, Data Management
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Salary Not Disclosed
1 Vacancy
Job Description
Job Description
Our client is a biopharmaceutical company committed to researching developing and commercializing transformative therapeutics to treat a broad spectrum of retinal diseases. Focusing on bringing new science to the design and manufacture of next-generation retinal medicines to prevent and treat the leading causes of blindness globally this role is on-site at the companys headquarters in Palo Alto CA so local candidates are preferred. The organizations three lead product candidates are in Phase III with BLAs to follow in the near term so there is a key opportunity here to play an integral role in submission activity.
Currently they are seeking a dedicated and detail-oriented Manager Data Management to contribute to database development data quality oversight and vendor coordination to ensure accurate compliant and submission-ready data. The ideal candidate will bring strong hands-on experience and a collaborative mindset working closely with cross-functional teams to drive successful trial execution and regulatory submissions.
- Support the design development and validation of clinical trial databases and electronic Case Report Forms (eCRFs) at the study level.
- Oversee data cleaning query resolution and delivery of high-quality datasets to support trial milestones and regulatory submissions.
- Collaborate with external data management vendors to ensure timely and high-quality deliverables; track performance against project timelines and quality standards.
- Participate in the preparation review and validation of submission-ready datasets for regulatory filings (e.g. NDA BLA MAA).
- Ensure compliance with industry standards and regulations (GCP FDA EMA) and assist in audit and inspection readiness.
- Coordinate with internal stakeholders including Clinical Operations Biostatistics Regulatory Affairs and IT to ensure smooth data integration and reporting.
- Contribute to the implementation and optimization of clinical data systems and tools (e.g. EDC data review platforms).
Please have :
- Bachelors degree in Life Sciences Data Science Computer Science or a related field.
- 7 years of experience in clinical data management within the biotech pharmaceutical or CRO industry.
- Experience managing study-level data management activities and working with external vendors.
- Familiarity with clinical data systems (e.g. Medidata RAVE Oracle Clinical Veeva) and industry data standards (e.g. CDISC SDTM).
- Demonstrated experience supporting regulatory submissions is a plus.
- Strong problem-solving organizational and communication skills.
This is a visible role in a smaller organization where you will have the opportunity to have real impact in this meaningful field.
Required Experience:
Manager
Employment Type
Full-Time
