Role: Central CRA
Location: Hyderabad
Company: RPS/ PRA/
working @: Novartis Hyderabad
Roles and responsibilities:
Location: Hyderabad
Company: RPS/ PRA/
working @: Novartis Hyderabad
Roles and responsibilities:
- Perform ongoing central remote monitoring of patient data using available online data sources (eCRF, IRT, central lab etc.) to ensure consistency and correctness of the data .
- Communicate any observations; deviations to protocol, safety alerts, quality issues, entry patterns, risk factors etc. that may affect the planned conduct of the trial to the clinical team and local ICRO organization / directly to site for timely follow-up actions and issue resolution.
- Perform data query resolution process (with site, local ICRO CRA and DM ) As required update ClinAdmin or other study management systems with e.g. key trial country and site event dates and enrollment figures.
- Provide input to the Monitoring Plan, eCRF design & review, and other documents and systems as applicable, ensuring accurate format for central monitoring.
- Acts as a close partner with the local ICRO CRAs, CSMs and Global Trial Lead.
- A team member of the clinical trial team (CTT) Interact with DM / CAF/ programming group and/or other line functions to ensure that efficient tracking and data reports are generated as required with flags and alerts for relevant deviations.
Salary: Negotiable
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