Job Description
MedTech Innovations is a leading provider of cutting-edge clinical research solutions, dedicated to accelerating the development of life-changing therapies. We are currently seeking a highly analytical and detail-oriented Senior Clinical Data Manager to join our dynamic Data Operations team in New York.
In this pivotal role, you will oversee the integrity, quality, and consistency of clinical trial data from source documents to database lock. You will collaborate closely with cross-functional teams including Clinical Operations, Biostatistics, and Medical Writing to ensure compliance with regulatory standards and internal quality policies.
If you are passionate about data integrity and have a strong background in clinical trials, we invite you to apply and help shape the future of healthcare.
Responsibilities
- Lead the data management lifecycle, including data cleaning, validation, and database lock preparation for Phase II-IV clinical trials.
- Develop and maintain comprehensive Data Management Plans (DMP) and CRF design specifications.
- Perform complex data queries and resolve discrepancies to ensure high data quality standards.
- Ensure strict adherence to regulatory guidelines (ICH-GCP, FDA 21 CFR Part 11) and internal SOPs.
- Train and mentor junior data managers and analysts on best practices and software tools.
- Conduct thorough source data verification (SDV) and audit trail reviews.
- Manage timelines and deliverables in alignment with project milestones.
Qualifications
- Bachelor’s degree in Biostatistics, Biology, Nursing, or a related scientific field (Master’s degree preferred).
- Minimum of 5 years of experience in Clinical Data Management within the pharmaceutical or biotechnology industry.
- Proficiency in Clinical Data Interchange Standards Consortium (CDISC) standards (SDTM, ODM, ADaM).
- Expertise in programming languages such as SAS, R, or SQL.
- Strong understanding of data integrity principles and regulatory requirements.
- Excellent communication skills and the ability to work effectively in a fast-paced, cross-functional team environment.