Location : Watertown, MA (Hybrid / Remote)
Science : Small Molecule
Therapeutic Area : Oncology
Job Overview : This role will independently manage and prioritize clinical study data procedures while providing expert guidance across international teams, effectively maintaining oversight as the data management subject matter expert.
Primary Job Responsibilities :
- Serve as the key data management expert on clinical project teams, guiding timelines and deliverables from study setup to database lock, with continuous monitoring of data management activities.
- Oversee the development and testing of clinical databases and data cleaning procedures, utilizing Medidata Rave / Veeva, and enforce data integrity through comprehensive documentation and quality control.
- Manage collaborations with CROs and third-party vendors, oversee data analysis and reconciliation, and communicate project updates and metrics to enhance decision-making and reporting accuracy.
Primary Job Requirements :
- Bachelor’s Degree in Life sciences, including a min of 8 years in CDM, leading critical oncology or immunology projects from startup to database lock, adept at handling data for regulatory submissions, and proficient in Veeva EDC system management with a solid scientific educational background.
- Skilled in using a variety of data management tools and systems (e.g., IRT, ePRO, Veeva CDMS, Oracle), focusing on data integrity and effective communication of data standards and practices.
- Expert in GCDMP, CDISC standards, regulatory compliance (21 CFR Part 11, GDPR), and proficient in MedDRA and WHO-Drug coding, ensuring adherence to ICH GCP and industry standards.
About Stratacuity :
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