Job Description
Are you ready to shape the future of medicine?
BioMed Innovations is a global leader in biotechnology, dedicated to developing breakthrough therapies that improve patient lives. We are seeking a highly analytical and detail-oriented Senior Clinical Data Manager to join our dynamic Data Operations team in Cambridge, MA. In this pivotal role, you will oversee the integrity of clinical trial data, ensuring compliance with global regulations and contributing to our mission of delivering safe and effective treatments.
Why Join Us?
- Work with cutting-edge technology in a state-of-the-art facility.
- Collaborate with cross-functional teams across the globe.
- Competitive compensation package and comprehensive benefits.
Our Commitment:
We are committed to fostering an inclusive and diverse workplace. We encourage applicants from all backgrounds to apply.
Responsibilities
- Lead Data Management Operations: Oversee the end-to-end data management lifecycle for Phase I-III clinical trials, ensuring accurate and timely data capture and submission.
- System Management: Manage and configure clinical data capture systems, including Medidata Rave and Oracle Clinical, ensuring optimal performance and user training.
- Data Integrity & Quality Assurance: Implement and monitor Data Quality Management Plans (DQMP) to ensure data integrity, consistency, and compliance with Good Clinical Practice (GCP) and ICH guidelines.
- Statistical Collaboration: Partner with biostatisticians to define edit checks, resolve queries, and perform data cleaning and validation to support statistical analysis.
- Vendor Management: Supervise external CROs and vendors, providing clear direction and monitoring deliverables to ensure alignment with project timelines.
- Documentation: Maintain comprehensive documentation of data management processes, change requests, and resolution of data issues.
Qualifications
- Education: Bachelor’s degree in Bioinformatics, Statistics, Life Sciences, or a related field; Master’s degree is preferred.
- Experience: Minimum of 5+ years of experience in Clinical Data Management, including at least 2 years in a leadership or senior capacity.
- Technical Skills: Proficiency in Clinical Data Management systems (e.g., Rave, Rhapsody) and programming languages such as SAS, R, or SQL.
- Regulatory Knowledge: Deep understanding of GCP, FDA 21 CFR Part 11, and EMA guidelines regarding electronic data capture.
- Soft Skills: Excellent communication skills, ability to influence cross-functional teams, and strong problem-solving abilities under tight deadlines.