Job Description
Are you ready to shape the future of healthcare? Apex Medical Innovations is seeking a highly skilled and strategic Senior Clinical Data Manager to join our dynamic team in Boston. We are dedicated to accelerating drug development and improving patient outcomes through rigorous data integrity and innovative methodologies.
As a leader in the biopharmaceutical space, we offer a competitive salary, comprehensive benefits, and a collaborative environment that fosters professional growth. If you have a passion for data quality and clinical research, we want to hear from you.
Responsibilities
- Lead the data management strategy for Phase II-IV clinical trials, ensuring compliance with ICH-GCP and FDA regulations.
- Design and implement complex data models using CDISC SDTM/ADaM standards.
- Oversee the end-to-end data capture process, including CRF design, electronic data capture (EDC) setup, and query management.
- Perform rigorous data validation and quality assurance checks to ensure data accuracy and integrity.
- Collaborate closely with cross-functional teams, including Clinical Operations, Biostatistics, and Medical Writing.
- Train and mentor junior data managers, fostering a culture of excellence.
Qualifications
- Master’s degree in Life Sciences, Informatics, or a related field (or equivalent experience).
- Minimum of 5 years of experience in Clinical Data Management within the pharmaceutical or biotechnology industry.
- Proficiency in data management systems (e.g., Rave, Oracle Clinical) and statistical software (SAS, R, or Python).
- Strong knowledge of CDISC standards (SDTM, DEFINE/ADaM) and regulatory guidelines.
- Excellent problem-solving skills and attention to detail.
- Strong verbal and written communication abilities.