Job Description
Join the Pioneers of Modern Medicine.
NexGen BioPharma Solutions is a leading innovator in the pharmaceutical landscape, dedicated to accelerating the development of life-saving therapies. We are seeking a highly skilled and strategic Senior Clinical Data Manager (CDM) to join our dynamic team in Boston, Massachusetts. In this pivotal role, you will oversee the integrity and quality of clinical trial data, ensuring compliance with global regulatory standards while driving efficiency in our data management operations.
Why Join Us?
• Impactful Work: Contribute to therapies that improve patient outcomes worldwide.
• Competitive Compensation: Base salary of $140k-$185k plus comprehensive benefits.
• Professional Growth: Access to cutting-edge training and mentorship programs.
The Opportunity:
We are looking for a leader who can bridge the gap between technical data management and clinical research objectives. As a Senior CDM, you will manage complex data lifecycles, lead validation strategies, and mentor junior staff to ensure the highest standards of data quality and reproducibility.
Responsibilities
- Lead Data Strategy: Define and implement data management strategies, including data cleaning, validation, and locking protocols for Phase II-IV clinical trials.
- Compliance & Standards: Ensure strict adherence to CDISC standards (SDTM, ADaM) and regulatory guidelines (FDA, EMA, ICH) throughout the data lifecycle.
- Team Leadership: Mentor and guide a team of Data Management Associates, providing technical guidance and performance feedback.
- Vendor Management: Oversee external data management vendors and CROs, ensuring deliverables meet NexGen quality standards.
- Project Oversight: Act as the key liaison between Clinical Operations, Biostatistics, and Programming teams to resolve data queries and discrepancies efficiently.
- Documentation: Maintain comprehensive data management documentation, including CRF design inputs, edit checks, and validation reports.
Qualifications
- Education: Bachelor’s degree in Life Sciences, Statistics, or related field; Master’s degree preferred.
- Experience: Minimum of 6-8 years of progressive experience in Clinical Data Management within the pharmaceutical or biotechnology industry.
- Technical Skills: Expert proficiency in CDISC standards (SDTM/ADaM), SQL, R, or SAS; experience with data validation tools (e.g., Rave, Oracle Clinical) is required.
- Methodology: Strong understanding of Clinical Trial Data Management methodologies and Data Validation techniques.
- Soft Skills: Exceptional communication skills, ability to prioritize in a fast-paced environment, and a proven track record of leading cross-functional projects.
- Regulatory Knowledge: Deep understanding of FDA 21 CFR Part 11 and GCP guidelines.