What are the responsibilities and job description for the Senior Clinical Data Manager position at Integrated Resources, Inc ( IRI )?
Data Manager / Data Quality Leader
Key Responsibilities
- Oversee collection, validation, and quality review of clinical and external data.
- Develop and manage clinical databases and data management solutions.
- Ensure compliance with CDISC standards, ICH-GCP, HIPAA, GDPR, and regulatory requirements.
- Manage vendors, CROs, and FSPs to ensure timely delivery of high-quality data.
- Monitor data quality using visualization tools, metrics, and statistical reviews to identify trends and anomalies.
- Support study start-up, conduct, database lock, audits, and inspections.
- Collaborate with cross-functional teams on data reporting, analytics, and stakeholder requirements.
- Oversee data transfer agreements, sample management, and external data integration.
- Apply FAIR principles (Findable, Accessible, Interoperable, Reusable) for data curation and management.
- Contribute to process improvements, new technologies, and enterprise-wide data initiatives.
Required Qualifications
- BS/MS in Life Sciences, Data Science, Bioinformatics, or related field.
- 5–10 years of clinical data management experience.
- Strong knowledge of CDISC, SDTM, ICH-GCP, and clinical regulations.
- Experience with clinical databases, EDC systems, and vendor oversight.
- Strong project management, communication, and leadership skills.
- Experience with analytics and visualization tools.
Preferred Skills
- Experience with clinical trial and real-world data management.
- Knowledge of SAS, R, Python, SQL, Tableau, or similar tools.
- Familiarity with AI/ML, Hadoop, Spark, and large-scale data systems.
- Experience with MedDRA, WHODrug, and reproducible research practices.
- Ability to mentor teams and manage multiple complex studies independently.
Salary : $80 - $82