R&D Reporting Specialist

Location: Irvine, California
Posted On: 8/4/2017
Job Code: 4710_Rep
Job Description
• Contribute to the set-up, maintenance and reporting of data in the HCP Payment and Spend System (HCP PASS). Monitor performance of reporting system and provide recommendations for process or system improvements where appropriate.
• Review contracts and payments to determine what must be reported against a healthcare provider (HCP) and/or teaching institution to comply with internal and government reporting purposes.
• Gather information to ensure that all payment and transfers of value information is captured and coded and provide guidance to influence appropriate decisions regarding all payment and in-kind reporting.
• Compile gathered information and perform data review cross checks to ensure information is accurate, complete and consistent. Identify missing, inaccurate, or incomplete data and liaise with functional areas to obtain updated data. Independently trouble shoot for missing data and documentation needed to complete required reporting.
• Key areas of collaboration include the following:
? Liaise with Clinical study team leads to gather details and documentation about reportable study supplies and equipment used in R&D clinical studies.
? Liaise with Compliance Operations to understand company reporting needs for R&D meetings. Work with R&D meeting owners to gather information about planned R&D meetings (e.g. investigator meetings, advisory board meetings). Review meeting request documentation for completeness (details about meeting attendees and venue) and coordinate compliance review.
Category:IT  code:new
Job Requirements
• Knowledge of clinical research and drug development concepts and FDA GCP/ICH regulatory guidelines, and understands clinical terminology
• Intermediate-advanced skills with Excel (skilled in using pivot tables and vlookups)

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Contact Details
Namrata Rani
E-mail Address