Job Description
Join the elite team at NexGen Therapeutics, a pioneer in innovative pharmaceutical research. We are seeking a highly skilled and motivated Senior Clinical Data Manager to lead our data operations for a groundbreaking Phase III clinical trial. In this pivotal role, you will ensure the integrity, accuracy, and security of our clinical data while collaborating with cross-functional teams to drive the development of life-changing therapies.
At NexGen, we foster a culture of innovation, scientific excellence, and inclusive growth. You will have the opportunity to work with cutting-edge technology and mentor junior staff in a dynamic, fast-paced environment.
Why Join Us?
- Competitive compensation and comprehensive benefits package.
- Flexible work arrangements and remote work options.
- Access to state-of-the-art biotech facilities in the heart of Cambridge.
- Continuous learning and professional development opportunities.
Responsibilities
- Lead the end-to-end clinical data management process, including data validation, cleaning, and locking for clinical trial databases.
- Define and execute data management plans (DMPs) in accordance with GCP and company SOPs.
- Mentor and supervise a team of Clinical Data Associates, providing performance feedback and guidance.
- Collaborate with Data Scientists and Statistical Programmers to ensure seamless data flow into analysis.
- Manage vendor relationships for third-party data entry and cleaning services.
- Implement and monitor data quality metrics to ensure 100% data integrity.
- Conduct data review meetings with the Clinical Operations team to resolve queries efficiently.
Qualifications
- Minimum of 5+ years of experience in Clinical Data Management within the pharmaceutical or biotechnology industry.
- Advanced proficiency in CDISC standards (SDTM, ADaM) and Clinical Data Interchange Standards Consortium.
- Experience with clinical data management systems (CDMS) such as Rave, Oracle Clinical, or Medidata Rave.
- Strong working knowledge of SQL, SAS, or Python for data extraction and manipulation.
- Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related field; Master’s degree preferred.
- Certification in Clinical Data Management (e.g., CDM, CDMP) is a plus.
- Excellent communication skills and the ability to thrive in a collaborative, cross-functional team environment.