Job Description
Join the forefront of medical innovation. NexGen Pharma Solutions is seeking a highly skilled Senior Clinical Data Manager to oversee critical data operations for our Phase III trials. You will play a pivotal role in ensuring data integrity, driving process improvements, and collaborating with cross-functional teams to accelerate drug development timelines. If you are passionate about transforming raw data into life-saving insights, we want to hear from you.
Why Join Us?
We offer a competitive benefits package, including equity options, comprehensive health coverage, and a dynamic work environment in the heart of Kendall Square.
Responsibilities
- Lead Data Management Strategy: Oversee the entire data management lifecycle, from database design to lock and archiving, ensuring compliance with FDA 21 CFR Part 11 and EMA GCP standards.
- Database Implementation: Spearhead the implementation and optimization of Electronic Data Capture (EDC) systems, specifically Oracle Clinical or similar platforms.
- Quality Assurance: Develop and execute comprehensive Quality Assurance plans, including data cleaning, validation, and monitoring to guarantee high data quality and integrity.
- Team Leadership: Mentor a team of Data Managers and Data Analysts, fostering a culture of continuous improvement and technical excellence.
- Regulatory Reporting: Prepare and review data sets for regulatory submissions (DMRs) and ensure timely delivery of study deliverables to sponsors.
- Process Optimization: Identify and implement process efficiencies and automation strategies to reduce cycle times and operational costs.
Qualifications
- Education: Bachelor’s degree in Life Sciences, Pharmacy, or related field; Master’s degree preferred.
- Experience: Minimum 5+ years of experience in Clinical Data Management within the pharmaceutical or biotechnology industry.
- Technical Skills: Proficiency in Rave, CTMS, and CDISC SDTM standards. Experience with SQL scripting is a strong plus.
- Regulatory Knowledge: In-depth understanding of GCP, ICH guidelines, and data privacy regulations (HIPAA).
- Communication: Excellent verbal and written communication skills with the ability to present complex data findings to non-technical stakeholders.
- Agile Mindset: Ability to thrive in fast-paced, agile environments with changing priorities.