Job Description
Are you a detail-oriented data professional passionate about advancing life sciences and bringing life-saving therapies to market? Apex BioPharma Solutions is seeking a Senior Clinical Data Manager to lead data integrity initiatives for our upcoming Phase III trials.
In this pivotal role, you will bridge the gap between clinical operations, biostatistics, and regulatory affairs. You will oversee the end-to-end data management lifecycle, ensuring compliance with GCP and 21 CFR Part 11 standards while leveraging cutting-edge technology to optimize trial efficiency.
Why Join Us?
• Competitive salary and comprehensive benefits package.
• Work with a world-class team dedicated to innovation.
• Flexible remote/hybrid work options in the heart of the biotech hub.
Responsibilities
- Lead the data management strategy for clinical trials, ensuring accurate and timely collection, cleaning, and documentation of data.
- Oversee the creation of Data Management Plans (DMP) and validate data collection tools (eCRF) in collaboration with IT and Clinical Operations.
- Ensure full compliance with GCP, ICH E6, and 21 CFR Part 11 regulations regarding electronic records and signatures.
- Mentor junior data managers and provide technical guidance on data standards and CDISC implementation.
- Collaborate with biostatisticians to generate analysis datasets (ADaM) and ensure data integrity for reporting.
- Manage vendor relationships (CROs) to ensure deliverables meet quality timelines.
Qualifications
- Bachelor’s degree in Life Sciences, Bioinformatics, Statistics, or a related field (Master’s degree preferred).
- Minimum of 5+ years of experience in Clinical Data Management within the pharmaceutical or biotechnology industry.
- Expert proficiency in SAS, SQL, and R for data manipulation and analysis.
- Strong knowledge of CDISC standards (SDTM, ADaM) and mapping specifications.
- Proven experience managing data validation processes and troubleshooting complex data issues.
- Excellent communication skills, with the ability to present technical data to non-technical stakeholders.