BioSpace
Senior Clinical Data Manager / Manager, Clinical Data Management
BioSpace, Palo Alto, California, United States, 94306
Senior Clinical Data Manager / Manager, Clinical Data Management
Kodiak Sciences is a biopharmaceutical company committed to researching, developing, and commercializing transformative therapeutics to treat retinal diseases. We are seeking a dedicated, detail‑oriented data manager to support data management activities for clinical trials. The role will contribute to database development, data quality oversight, and vendor coordination to ensure accurate, compliant, and submission‑ready data. This is an in‑office role based in Palo Alto, California.
Responsibilities
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).
Education & Qualifications
Bachelor’s degree in Life Sciences, Data Science, Computer Science, or related field.
7+ years of experience in clinical data management within 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.
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Responsibilities
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).
Education & Qualifications
Bachelor’s degree in Life Sciences, Data Science, Computer Science, or related field.
7+ years of experience in clinical data management within 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.
#J-18808-Ljbffr