Job Description
Join our pioneering team at MedTech Innovations where we're revolutionizing patient care through cutting-edge clinical research. We're seeking a Senior Clinical Data Manager to oversee complex clinical trial data integrity and compliance with global regulatory standards. This role offers the opportunity to work directly with life-changing therapies while mentoring a talented data team in our state-of-the-art Boston facility.
As a key member of our Clinical Operations division, you'll ensure data accuracy throughout the clinical trial lifecycle while collaborating with cross-functional teams to accelerate therapeutic development. Our commitment to innovation is matched only by our dedication to employee growth through continuous learning programs and industry certifications.
Responsibilities
- Design, implement, and maintain clinical database structures for multi-phase clinical trials
- Ensure data integrity through rigorous validation checks and quality control procedures
- Generate and analyze clinical data reports for regulatory submissions (FDA, EMA, etc.)
- Lead data migration activities between clinical systems while maintaining audit trails
- Mentor junior data management staff and develop departmental SOPs
- Collaborate with biostatisticians on data analysis plans and reporting
- Conduct internal audits and ensure compliance with 21 CFR Part 11 and GCP standards
Qualifications
- Bachelor's degree in Health Information Management, Statistics, or related field (Master's preferred)
- 5+ years clinical data management experience in pharmaceutical or CRO environment
- Expertise in Medidata Rave and Oracle Clinical databases
- Strong knowledge of CDISC standards (SDTM, ADaM) and regulatory requirements
- Certification in Clinical Data Management (CCDM) or equivalent
- Experience with SAS programming for data validation and reporting
- Proven ability to manage complex datasets in multi-center international trials
- Exceptional attention to detail and problem-solving abilities