We feel that your skills are inline with our current requirements for Sr. Clinical Solution Consultant positions.
Roles and Responsibilities:
· Guide the customer during the initial requirements process so that the EDC specification takes advantage of clients EDC platform capabilities in achieving the functionality needed by the customer.
Work with customer and Application Development team to transfer a clear
understanding of the requirements (including CRF design, edit checks, clinical
workflow), anticipate customer needs (to reduce the likelihood of future change
requests) and remove ambiguity in the requirements process.
Complete and baseline the specification documents (UI wireframes, edit check
and workflow specifications, etc).
Work with the customer to define the data transfer plan, data integration points
and reporting/listing requirements.
Help to define and enforce data collection and data management standards and comply with all regulatory requirements.
Mandatory Skills:
4+ years Experience with clinical trials and the associated clinical operations workflow in bio-pharma and /or medical devices.
Solid understanding of clinical trial protocols, CRF layout, clinical data collection and management issues.Effective communication skills, both oral and written and the ability to engage the customer during the requirements phase and manage customer expectations.
Competent in the use of MS Office, Self directed and detail-oriented.
Ability to collaborate with internal and external teams and work effectively using web-meetings to review and revise requirements.
Knowledge of quality assurance processes in a FDA regulated software development environment.
In case you are interested please send me a copy of your Updated CV to Preejith.shashi@proteans.com or for more information call me Preejith @ 080-66186513
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