Minimum of 5 years? experience managing data in support of clinical research.
? Experience working with complex external data e.g., Biomarkers, Genomics, imaging or similar.
? Demonstrated project management skills.
Coordinates external Data stream set-up and post-production changes, ensuring quality and timely delivery according to established timelines.
Collaborates with External Data Provider and key stakeholders to ensure that data capture aligns with requirements.
Provides input on data collection Strategy.
Sets up data transfer specifications and data transfer mechanisms for external data streams.
Follows up on data transfer issues with (E)DP?s.
Identifies potential risks and communicates with study team in collaboration with the GDM.
Acts as point of contact for GDM, DAE and CP on the standardization of external data.
Candidate should have worked in Oncology, Cross TA , Immunology or Medical affairs Therapeutic area.
Should have hands on experience on DTA/DTS, tsDTA preparation.
Test Concept Mapping.
Test transfer file review.
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