Description
We are seeking a Clinical Data Management Specialist to join our team in Bengaluru, India. As a Clinical Data Management Specialist, you will play a critical role in delivering high-quality clinical data management services across multiple studies.
Key Responsibilities:
- Design, write, and maintain database programs and scripts in CQL, R, and Python to acquire, transform, reconcile, and quality-check clinical and external vendor data.
- Identify, evaluate, and pilot AI/ML and automation solutions, working with Data Management and Clinical teams.
- Deliver multiple clinical studies across all data acquisition activities, including timelines, oversight, and governance of external vendors.
- Advise Study Core Team members on DM operational and technical requirements and provide input to study design, protocol, and study planning.
- Mediate and solve data acquisition issues, escalating as needed, and report status and risks to the Study Data Manager.
- Apply CDISC/SDTM standards and develop programmatic transformations of clinical laboratory and vendor data.
- Ensure programmed and AI/ML-enabled solutions are validated, auditable, and explainable, and comply with GxP, ICH-GCP, data privacy, and GSK AI governance.
- Act as Subject Matter Expert for process improvement, new processes, training, quality assessments, audits, and inspections.
Requirements:
- Bachelor's degree or equivalent in Engineering, Life Sciences, Computer Science, Mathematics, Physics, or equivalent.
- 8+ years of experience in data acquisition or related roles in clinical research or information systems.
- Demonstrated ability to deliver clinical data management tasks to time, quality, and DM process compliance.
- Experience with CDISC standards, including SDTM.
- Proficiency in SQL with working knowledge of R and Python for data extraction, transformation, reconciliation, validation, and reporting.
- Experience working in database systems and environments; understanding of data flow and database architecture concepts.
- Working understanding of core AI/ML concepts and their limitations.
Preferred Qualifications:
- Hands-on experience applying analytics, automation, or AI/ML in clinical data management or a related data-intensive environment.
- Experience developing programmatic transformations of clinical laboratory data; knowledge of medical terminology related to biospecimen collection and assessment.
- Expertise in eDC solutions (InForm, Rave, Veeva CDMS/Vault) and ePRO/eCOA solutions.
What We Offer:
- Competitive salary and benefits package.
- Opportunity to work with a global biopharma company.
- Collaborative and dynamic work environment.
How to Apply:
If you are interested in this opportunity, please submit your application through our website.