Job Description
Are you passionate about leveraging data to transform patient outcomes? Precision Health Analytics is seeking a highly skilled and detail-oriented Clinical Data Manager to join our dynamic team in San Francisco.
In this pivotal role, you will oversee the integrity, quality, and timely delivery of clinical data across our growing portfolio of therapeutic programs. We offer a competitive salary, comprehensive benefits, and a collaborative culture that values innovation, technical excellence, and professional growth. If you have a strong background in Life Sciences and Data Management, we want to hear from you.
Why Join Us?
- Work with cutting-edge biotechnology technology.
- Competitive salary and equity package.
- Comprehensive health, dental, and vision insurance.
- Flexible remote work options and continuous learning stipends.
Responsibilities
- Lead the data management process for clinical trials, ensuring data is accurate, complete, and compliant with regulatory standards (GCP & 21 CFR Part 11).
- Design, develop, and implement complex database schemas and Case Report Forms (CRFs) using Rave or similar CTMS.
- Develop and execute rigorous data validation plans and edit checks to identify discrepancies in real-time.
- Collaborate closely with cross-functional teams, including Data Scientists, Regulatory Affairs, and Statistical Programming, to support study objectives.
- Perform thorough data cleaning and reconciliation to prepare high-quality datasets for statistical analysis and regulatory submissions.
- Maintain and update data management systems and Standard Operating Procedures (SOPs) to reflect best practices.
- Prepare and deliver clear, concise data management reports to stakeholders and project sponsors.
Qualifications
- Bachelor’s degree in Life Sciences, Biotechnology, or a related field required; Master’s degree in Health Informatics or Data Science is a strong plus.
- 3-5 years of progressive experience in Clinical Data Management, preferably in the Biotechnology or Pharma industry.
- Proficiency in CDISC standards (SDTM, ADaM) and clinical data tools (Rave, REDCap, or Oracle Clinical).
- Strong analytical skills with expertise in Microsoft Excel, SQL, and data visualization tools (Tableau, PowerBI).
- Excellent communication skills, with the ability to present complex data to non-technical stakeholders.
- Deep understanding of Good Clinical Practice (GCP) and regulatory submission processes.