Job Description
Are you passionate about transforming raw data into life-saving insights? Apex Pharmaceuticals is seeking a highly skilled Senior Clinical Data Manager to lead our data integrity initiatives for our next generation of oncology therapeutics. In this pivotal role, you will oversee the lifecycle of clinical data, ensuring compliance with global regulatory standards while driving efficiency in our trial operations.
We offer a competitive compensation package, comprehensive benefits, and the opportunity to work in a collaborative environment dedicated to improving patient outcomes worldwide.
Responsibilities
- Oversee the clinical data management process from CRF design through database lock for Phase II-IV trials.
- Lead the Data Validation team, ensuring 100% accuracy of critical datasets before database lock.
- Collaborate with cross-functional teams, including Clinical Operations, Biostatistics, and Medical Writing, to resolve data queries efficiently.
- Implement and maintain CDISC standards (SDTM, ADaM) throughout the data life cycle.
- Manage vendor relationships with CROs and ensure deliverables meet Apex's quality benchmarks.
- Conduct source data verification (SDV) audits and data quality assessments.
Qualifications
- Master’s degree in Life Sciences, Pharmacy, or related field preferred; Bachelor’s degree with 5+ years of experience is acceptable.
- Proven experience with R4 (REDCap) or Oracle Clinical One data management systems.
- Strong proficiency in SQL and SAS for data extraction and manipulation.
- Deep understanding of GCP (Good Clinical Practice) and regulatory guidelines (FDA, EMA).
- Excellent project management skills with a track record of meeting tight deadlines.
- Strong communication skills to effectively translate complex data issues to non-technical stakeholders.