Clinical Registry Specialist
Do you have at least 5 years of experience in a clinical trial or regulatory affairs role within a regulated medical industry?
The Clinical Registry Specialist is responsible for developing processes and tools to support streamlined International disclosure for assigned countries. You act as Subject Matter Expert for supporting all of the operational aspects of the Clinical Registry workflow in support of study registration and result disclosures to public websites. You coordinate and maintain oversight on protocol registration and/or results disclosure in assigned countries. You ensure the quality of global operations and the data integrity of the Clinical Registry and associated external web sites by facilitating problem resolution for new users and customers.
Your responsibilities include. Understand the global clinical registry landscape and customer needs for protocol and/or results disclosure. Keep abreast of and document changing regulatory disclosure requirements for the assigned countries: Perform impact assessment and document required changes to the Clinical Registry Repository Content. Maintain up to date registration and disclosure intelligence (i.e. regulatory intelligence, registry intelligence,…) in the International Clinical Registry Repository.
The ideal candidate has a BSc in Science, Business, or Computer science / technology or equivalent with at least 5 years of experience in a clinical trial or regulatory affairs role within a regulated medical industry (Pharmaceutical, Medical Devices, Consumer, CRO and/or Biotech). You have experience with Quality and Compliance systems. Demonstrated competency in accurate work with clinical trial or regulatory data, data management, programming, scripting or data operations. Knowledge of procedural and records management requirements in a regulated industry is beneficial. The same applies to knowledge of the preclinical and clinical drug development process. Excellent knowledge of English is required
Voor meer informatie neem je contact op met Peter Debrichy, bereikbaar op telefoonnummer 023 55 78 529 of via e-mail: firstname.lastname@example.org Kenmerk: 7606.
XDES projects is specialist in recruitment van technisch personeel.
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