Job Description
Join Boston Medical Innovations, a leader in cutting-edge clinical research, as we revolutionize patient care through data-driven healthcare solutions. We're seeking a meticulous Clinical Data Manager to oversee the integrity of critical medical datasets that directly impact patient outcomes and regulatory compliance. Our collaborative environment offers competitive benefits, continuous learning opportunities, and the chance to shape the future of precision medicine.
Responsibilities
- Design, implement, and maintain robust clinical databases ensuring data integrity and regulatory compliance (FDA/ICH-GCP)
- Collaborate with cross-functional teams to define data requirements and develop Case Report Forms (CRFs)
- Perform data validation, cleaning, and quality control procedures using SAS and Oracle Clinical
- Generate statistical analysis datasets and support biostatisticians in clinical trial reporting
- Manage adverse event coding using MedDRA dictionary and maintain audit trails
- Lead internal/external audits and ensure adherence to 21 CFR Part 11 requirements
- Mentor junior data management staff and optimize data workflows
Qualifications
- Bachelor's degree in Health Informatics, Statistics, or related field (Master's preferred)
- 5+ years clinical data management experience in pharmaceutical/biotech
- Expertise in CDISC standards (SDTM, ADaM) and EDC systems (e.g., Medidata Rave)
- Advanced proficiency in SAS programming for clinical data analysis
- Certified Clinical Data Manager (CCDM) or equivalent certification
- Strong knowledge of ICH-GCP, FDA regulations, and clinical trial processes
- Exceptional problem-solving skills with attention to detail
- Experience with regulatory submissions (IND/BLA/NDA)