pCRF Designer Job Description 1. Create all pCRFs for a given study based on standard rules & guidelines. Ensure global consistency by developing the pCRFs using the standard naming conventions and the existing library of global / TA-specific standard pCRFs. Many forms will have to be created from scratch and entered into the global central pCRF library.
2. Interpret from protocol summary and protocol, the pertinent medical/scientific data that will comprise the pCRFs employed in clinical trials.
3. Work closely with Data Management and clinical team to determine timeframes and gather input into pCRF design, to achieve a timely approval.
4. Actively participates in CAPA and pCRF review meetings to discuss the pCRFs for a clinical project and offer suggestions regarding pCRF format and data collection requirements.
5. In addition, make changes to pCRFs based on decisions from the Clinical Team and ensure that request for approvals are filed for deviations from standards.
6. Distribute the revised pCRFs, appropriately.
7. Review study protocols for completeness and ensure consistency with CRFs.
8. Prepare print/shipment specifications and ensure proper procedures are followed for printing of pCRF books
Desired Profile • University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree.
• 6 months or more experience in software based paper forms design.
• Fluent English (oral and written).
• Intermediate knowledge of medical terminology.
• Position will require the individual to be creative and consistent in the design of all case report forms, realizing the overall business perspective and benefits of standardization. For multiple studies, consistency of data on pCRFs between studies is important for a valid statistical analysis and eventual integrated medical summary.
• Good knowledge of Clinical Research practices and procedures, stages of clinical trials, requirements and guidelines for data collection.
• Knowledge of SW used within pCRF Design (EDM), specifically the electronic publishing system for pCRF production.
• Working knowledge of Microsoft office tools, electronic mail systems, and web-based systems.
• Willingness to learn. Excellent interpersonal skills and ability to communicate clearly and effectively both orally and in writing.
Experience 0 - 3 Years
Industry Type Pharma/ Biotech/Clinical Research
Functional Area Healthcare, Medical, R&D
Location Hyderabad / Secunderabad
Keywords pCRF Designing
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