Job Description
Join the Leader in Innovation
ApexBio Therapeutics is a cutting-edge biotechnology firm dedicated to pioneering novel therapies for complex diseases. We are seeking a highly skilled Senior Clinical Data Manager to join our dynamic team in Boston. In this pivotal role, you will drive data integrity, oversee database lifecycles, and ensure compliance with global regulatory standards.
Why Apply?
- Work with state-of-the-art EDC systems and statistical programming.
- Collaborate with cross-functional teams including Biostatisticians and Clinical Operations.
- Competitive compensation and comprehensive benefits package.
Key Responsibilities
- Lead the design, development, and implementation of clinical trial databases, ensuring robust data architecture.
- Monitor data quality throughout the study lifecycle, implementing corrective actions to maintain integrity.
- Program and validate database edits, queries, and tables using SAS, R, or SQL.
- Liaise with Clinical Operations and CROs to resolve data queries and ensure timely data transfer.
- Support regulatory submissions by providing clean, validated datasets and documentation.
- Train and mentor junior data managers and ensure adherence to GCP (Good Clinical Practice) guidelines.
Qualifications
- Bachelor’s or Master’s degree in Life Sciences, Statistics, or a related field.
- Minimum of 5 years of experience in Clinical Data Management within the pharmaceutical or biotechnology industry.
- Proficiency in statistical programming languages (SAS, R, or SQL) and EDC systems (e.g., Medidata Rave, Oracle Clinical).
- Strong understanding of data validation strategies and regulatory requirements (FDA, EMA).
- Excellent communication skills with the ability to present complex data to non-technical stakeholders.
- Proven track record of managing timelines and deliverables in fast-paced environments.
Responsibilities
- Lead the design, development, and implementation of clinical trial databases, ensuring robust data architecture.
- Monitor data quality throughout the study lifecycle, implementing corrective actions to maintain integrity.
- Program and validate database edits, queries, and tables using SAS, R, or SQL.
- Liaise with Clinical Operations and CROs to resolve data queries and ensure timely data transfer.
- Support regulatory submissions by providing clean, validated datasets and documentation.
- Train and mentor junior data managers and ensure adherence to GCP (Good Clinical Practice) guidelines.
Qualifications
- Bachelor’s or Master’s degree in Life Sciences, Statistics, or a related field.
- Minimum of 5 years of experience in Clinical Data Management within the pharmaceutical or biotechnology industry.
- Proficiency in statistical programming languages (SAS, R, or SQL) and EDC systems (e.g., Medidata Rave, Oracle Clinical).
- Strong understanding of data validation strategies and regulatory requirements (FDA, EMA).
- Excellent communication skills with the ability to present complex data to non-technical stakeholders.
- Proven track record of managing timelines and deliverables in fast-paced environments.