Job Description
Join Apex BioPharma Solutions, a pioneering force in clinical research dedicated to accelerating breakthrough therapies for patients in need. We are looking for a Senior Clinical Data Manager to lead our data operations team and ensure the highest standards of data integrity across our global Phase IIāIV trials.
In this pivotal role, you will collaborate with cross-functional teamsāincluding clinical operations, biostatistics, and medical writingāto design, execute, and validate clinical data management processes. If you are a strategic thinker with a passion for data quality and a drive to improve patient outcomes, we want to meet you.
Responsibilities
- Lead Data Management Operations: Oversee the entire data management lifecycle, from database design and setup to data cleaning, validation, and final delivery, ensuring compliance with GCP and FDA regulations.
- Database Management: Utilize industry-leading EDC systems (e.g., Veeva Vault, Medidata Rave) to configure database schemas, create edit checks, and manage metadata and documentation.
- Data Quality Assurance: Implement rigorous data validation plans, perform trend analysis, and drive initiatives to reduce data queries and ensure 100% data lock readiness.
- Project Leadership: Act as the primary point of contact for data management stakeholders, providing expert guidance on data-related issues and timelines.
- Interdisciplinary Collaboration: Partner with biostatisticians and medical writers to resolve data discrepancies and support statistical analysis plans (SAP).
- Process Improvement: Identify opportunities to optimize clinical data workflows, reduce cycle times, and enhance overall operational efficiency.
Qualifications
- Education: Bachelorās degree in Life Sciences, Mathematics, Computer Science, or a related field; Masterās degree preferred.
- Experience: Minimum of 5+ years of experience in Clinical Data Management within the pharmaceutical or biotechnology industry.
- Technical Proficiency: Solid working knowledge of CDISC standards (SDTM, ADaM), SQL, and statistical programming languages (SAS, R, or Python).
- System Knowledge: Hands-on experience with EDC systems, specifically Medidata Rave or Veeva Vault.
- Regulatory Compliance: Deep understanding of Good Clinical Practice (GCP), ICH E6(R2), and local regulatory requirements.
- Soft Skills: Excellent communication skills, strong leadership abilities, and a proactive problem-solving mindset.