Job Description
We are seeking a visionary Senior Clinical Data Manager to join our elite team in San Francisco. At Apex Health Solutions, we are revolutionizing patient care through data-driven insights. You will play a pivotal role in ensuring the integrity, quality, and security of our clinical trial data while working alongside world-class biostatisticians and clinicians.
Why Join Apex Health?
- Competitive compensation package up to $120k.
- Comprehensive health, dental, and vision insurance.
- Flexible remote and hybrid work options.
- Continuous professional development and certification support.
Responsibilities
- Lead the end-to-end lifecycle of clinical data management, including data entry, validation, and cleaning for Phase I-III trials.
- Develop and enforce rigorous data management plans and standard operating procedures (SOPs) compliant with ICH-GCP.
- Perform complex data reconciliation and validation checks to ensure 100% data integrity and accuracy.
- Collaborate closely with Clinical Operations, Biostatistics, and Regulatory Affairs to resolve discrepancies and queries.
- Oversee the data lock process and prepare data sets for statistical analysis.
- Mentor junior data managers and contribute to team training and process improvement initiatives.
Qualifications
- Bachelor’s degree in Life Sciences, Biostatistics, or a related technical field (Master’s degree preferred).
- Minimum of 5 years of experience in Clinical Data Management or a similar role within the pharmaceutical or biotechnology industry.
- Proficiency in EDC systems (e.g., REDCap, Oracle Clinical, Medidata Rave) and database query languages (SQL).
- Deep understanding of ICH-GCP guidelines and FDA regulations regarding data integrity.
- Exceptional attention to detail, analytical thinking, and problem-solving capabilities.