Job Description
Are you ready to accelerate life-changing therapies? Apex Pharma Solutions is seeking a visionary Senior Clinical Data Manager to join our elite biotechnology team in Boston. In this pivotal role, you will be the guardian of data integrity for our Phase III trials, ensuring our clinical insights drive the next generation of medical breakthroughs. We pride ourselves on a culture of innovation, offering a competitive salary and a flexible, remote-first work environment.
Our Commitment to You:
- Competitive compensation package (Base $110k - $145k + Bonus).
- Comprehensive health, dental, and vision insurance.
- Unlimited PTO and professional development stipends.
Responsibilities
- Lead the end-to-end design, development, and implementation of Clinical Data Management (CDM) systems, ensuring strict adherence to CDISC SDTM and ADaM standards.
- Oversee the execution of comprehensive data validation plans and perform detailed data quality checks to maintain the highest standards of data integrity.
- Act as the primary liaison for data management activities with Contract Research Organizations (CROs), Clinical Research Sites, and internal cross-functional teams.
- Develop and review rigorous Data Review Memos (DRMs) and Data Quality Assessment (DQA) reports to support regulatory submissions.
- Mentor junior data managers and conduct technical training sessions to enhance the overall proficiency of the data management team.
- Ensure full compliance with Good Clinical Practice (GCP) guidelines and regulatory body requirements (FDA, EMA).
Qualifications
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Statistics, or a related field (minimum 5 years of experience required).
- Advanced proficiency in data management software such as SAS, R, or SQL.
- Strong working knowledge of CDISC standards, including SDTM, ADaM, and DEFINE/ADaM.
- Proven experience managing large-scale clinical data sets from study start-up through database lock.
- Strong project management skills with the ability to prioritize tasks in a fast-paced, deadline-driven environment.
- Excellent communication skills and a collaborative mindset essential for cross-functional success.