Job Description
Join the vanguard of healthcare innovation at Apex Health Systems. We are looking for a highly skilled Clinical Data Manager to oversee the integrity and quality of our global clinical trials. In this pivotal role, you will bridge the gap between clinical operations and data science, ensuring that our research drives real-world patient outcomes.
Key Highlights:
• Work with cutting-edge EDC systems (Rave, Oracle Clinical)
• Hybrid work model with a focus on work-life balance
• Comprehensive benefits package including medical, dental, and vision
Responsibilities
- Lead the design and implementation of data management plans (DMPs) and data governance strategies in compliance with FDA 21 CFR Part 11 and ICH guidelines.
- Oversee the mapping of Case Report Forms (CRFs) to the Statistical Analysis Plan (SAP) and support SDTM/ADaM data generation.
- Conduct rigorous data audits, reconciliation, and cleaning to ensure 100% data integrity before database lock.
- Liaise effectively with cross-functional teams including Clinical Operations, Biostatistics, and Medical Writing to resolve data queries and discrepancies.
- Mentor junior data management staff and conduct training sessions on data standards and quality assurance processes.
- Manage timelines and deliverables within tight regulatory deadlines.
Qualifications
- Master’s degree in Life Sciences, Biostatistics, or Health Informatics (or equivalent combination of education and experience).
- Minimum of 5+ years of experience in Clinical Data Management within the pharmaceutical or biotechnology industry.
- Advanced proficiency in CDISC standards (SDTM, ADaM) and SQL.
- Hands-on experience with clinical data systems such as Medidata Rave or Oracle Clinical.
- Strong knowledge of Good Clinical Practice (GCP) and regulatory submission requirements.
- Proven track record of leading cross-functional teams and managing complex projects.