Job Description
Are you ready to shape the future of life sciences?
NovusMed Research is a leader in biopharmaceutical innovation, and we are looking for a highly skilled Senior Clinical Data Manager to join our dynamic team in Boston. In this pivotal role, you will oversee the integrity, accuracy, and security of clinical trial data, ensuring that our groundbreaking therapies reach patients safely and efficiently.
Why Join Us?
- Work on cutting-edge therapeutics with global impact.
- Competitive compensation and comprehensive benefits package.
- Access to state-of-the-art data infrastructure and training.
- A collaborative culture that values diversity and scientific excellence.
Key Responsibilities:
- Lead the design, development, and implementation of clinical data management plans for Phase I-IV trials.
- Ensure strict adherence to CDISC standards (SDTM, ADaM) and GCP guidelines.
- Oversee data cleaning, validation, and reconciliation processes to guarantee high data quality.
- Collaborate with cross-functional teams, including statisticians, medical writers, and clinical operations, to resolve data discrepancies.
- Mentor junior data managers and contribute to team training and process improvement initiatives.
- Implement robust data security and privacy protocols compliant with HIPAA and international regulations.
Qualifications:
- Bachelor’s or Master’s degree in Life Sciences, Informatics, or a related field.
- Minimum of 5 years of experience in Clinical Data Management within the pharmaceutical or biotech industry.
- Proficiency in CDISC standards and clinical data management systems (e.g., Rave, Oracle Clinical, or similar).
- Strong working knowledge of SQL, SAS, or Python for data manipulation.
- Excellent analytical skills with a keen eye for detail.
- Experience with regulatory submissions (e.g., NDAs, BLAs) is a plus.
Ready to make a difference? Apply today!
Responsibilities
- Lead the design, development, and implementation of clinical data management plans for Phase I-IV trials.
- Ensure strict adherence to CDISC standards (SDTM, ADaM) and GCP guidelines.
- Oversee data cleaning, validation, and reconciliation processes to guarantee high data quality.
- Collaborate with cross-functional teams, including statisticians, medical writers, and clinical operations, to resolve data discrepancies.
- Mentor junior data managers and contribute to team training and process improvement initiatives.
- Implement robust data security and privacy protocols compliant with HIPAA and international regulations.
Qualifications
- Bachelor’s or Master’s degree in Life Sciences, Informatics, or a related field.
- Minimum of 5 years of experience in Clinical Data Management within the pharmaceutical or biotech industry.
- Proficiency in CDISC standards and clinical data management systems (e.g., Rave, Oracle Clinical, or similar).
- Strong working knowledge of SQL, SAS, or Python for data manipulation.
- Excellent analytical skills with a keen eye for detail.
- Experience with regulatory submissions (e.g., NDAs, BLAs) is a plus.