Job Description
Are you a detail-oriented data specialist ready to shape the future of medicine? Apex Clinical Research is seeking a visionary Senior Clinical Data Manager to join our elite team in Boston. In this pivotal role, you will oversee the integrity, quality, and timeliness of clinical data across our global Phase 3 trials. We are looking for a leader who thrives in a fast-paced environment and is passionate about ensuring that every dataset drives life-saving breakthroughs.
Why Join Us?
- Work with cutting-edge technology in a state-of-the-art biotech hub.
- Competitive compensation package and comprehensive benefits.
- Opportunities for international travel and professional development.
Key Responsibilities:
- Lead Data Management Operations: Spearhead the planning, design, and execution of data management strategies for complex clinical trials.
- Database Management: Oversee the creation and maintenance of electronic data capture (EDC) systems, ensuring seamless integration with other systems.
- Quality Assurance: Implement and monitor rigorous data cleaning and validation protocols to ensure 100% data integrity and compliance with GCP and regulatory standards.
- Regulatory Compliance: Ensure all data processes adhere to CDISC standards (SDTM, ADaM) and applicable FDA/EMA regulations.
- Collaboration: Act as the primary liaison between data management, biostatistics, medical writing, and clinical operations teams.
Qualifications:
- Experience: Minimum of 5-7 years of experience in clinical data management, preferably in the pharmaceutical or biotechnology sector.
- Education: Bachelor’s degree in Life Sciences, Statistics, or a related field; Master’s degree is a plus.
- Technical Skills: Proficiency in SAS, R, or SQL; experience with Oracle Clinical, REDCap, or Rave EDC systems.
- Methodology: Strong understanding of clinical trial methodologies, statistical concepts, and data modeling.
- Communication: Exceptional written and verbal communication skills with the ability to present complex data findings to non-technical stakeholders.
Ready to advance your career in a world-class organization? Apply now to become a part of our mission to deliver innovative therapies to patients worldwide.
Responsibilities
- Lead data cleaning and validation processes for clinical trial datasets.
- Manage the end-to-end data lifecycle from source data verification to database lock.
- Define and document data management plans (DMPs) and data standards.
- Ensure 100% compliance with Good Clinical Practice (GCP) and regulatory guidelines.
- Train and mentor junior data management staff.
Qualifications
- 5+ years of experience as a Clinical Data Manager.
- Expert knowledge of CDISC standards (SDTM/ADaM).
- Proficiency in statistical software (SAS, R, or SQL).
- Strong attention to detail and problem-solving abilities.
- Relevant certifications (e.g., CDMP, RAC) are highly desirable.