Job Description
Join Global Health Innovations, a leader in biopharmaceutical research, as our Senior Clinical Data Manager. You'll be instrumental in designing and implementing robust data management strategies for groundbreaking clinical trials, directly impacting patient care outcomes. Our Boston headquarters offers state-of-the-art facilities and a collaborative environment where your expertise will drive innovation in healthcare data solutions.
We offer comprehensive benefits including medical/dental/vision coverage, 401(k) matching, tuition reimbursement, and flexible work arrangements. Help us shape the future of medicine while advancing your career in one of the world's premier healthcare hubs.
Responsibilities
- Design and implement clinical data management plans for Phase I-III trials
- Oversee data cleaning, validation, and quality assurance processes
- Lead CDISC-compliant data mapping and database development
- Collaborate with cross-functional teams (biostatisticians, clinicians, regulatory)
- Ensure compliance with FDA 21 CFR Part 11 and ICH-GCP guidelines
- Mentor junior data management staff and optimize workflows
- Contribute to process improvements and SOP development
Qualifications
- Master's degree in Health Informatics, Biostatistics, or related field
- 5+ years clinical data management experience in biotech/pharma
- Advanced proficiency in SAS programming and Oracle RDBMS
- Certified Clinical Data Manager (CCDM) preferred
- Deep knowledge of CDISC standards (SDTM, ADaM, Define.xml)
- Experience with EDC systems (Medidata Rave, Veeva Vault)
- Strong problem-solving skills and attention to detail
- Excellent communication and stakeholder management abilities