: 6-9 months relevant experience in Data Acquisition OR related experience Responsibilities
Performs a wide range of Data Acquisition activities ensuring that the non CRF data is collected as per data collection standards.
Lead the collection of non-crf data during study set-up, conduct and close out activities across multiple studies, contributing to fit for quality.
Responsible for data acquisition, specification, loading and delivery of non crf data across different vendors.
4. Provide input during protocol review to ensure clarity of data collection requirement.
Identify non-CRF data collection requirement from protocol. Create and Maintain
Data Handling Strategy (DHS) document after consulting with Roche stake holders.
Create and finalize File Format Specifications document in alignment with GDSR
standards for non CRF data collection.
Collaborate with client to agree with vendor expectations for non CRF data collection
And data transfer.
Responsible for obtaining relevant signatures on finalized FFS, uploading finalized FFS
PDF document in eTMF, uploading DHS and FFS in Touch point area
Raise tickets within Roche systems for approval of non-crf data collection requirements
that are not covered in global standards.10. Manage CDM non crf deliverables, identify risks and coordinate cross functional tasks with adequate understanding of upstream and downstream processes, as applicable.
Perform eTMF review to check completeness and compliance of FFS upload.
12. Keep Team Lead and Higher Management fully informed about the study updates and challenges.13. Serves as backup to other Data acquisition specialist. Quality
Ensure to deliver high quality work and follow effective DAS processes within the function
Ensures compliance to all relevant Roche and TCS SOPs and documentation requirement of staff training/ assessment