Senior Registry & Results Disclosure Lead

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View: 234

Update day: 25-04-2024

Location: Basel Basel-Stadt BS

Category: IT - Software

Industry: Staffing Recruiting

Position: Mid-Senior level

Job type: Contract

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Job content

A Registry & Results Disclosure Lead is required to join a global pharmaceutical company on a long-term contract in Basel. This role is scheduled to run for 12-15 months initially.The Registry & Results Disclosure Lead role combines scientific data handling, cross-functional project management and communication to deliver timely and compliant disclosure of Company-sponsored clinical trial data.The Registry & Results Disclosure Lead is responsible for executing disclosure activities for sponsored trials, including protocol registration and results disclosure, ensuring compliance with legal requirements and in line with Company transparency commitments, and providing high-quality disclosure deliverables.An assigned administrator for centralized data entry into our Clinical Trial Registry system, the Registry & Results Disclosure Lead ensures posting of trial information onto ClinicialTnals.gov, EudraCT and specific local registries. A master at proactive planning and communication with interfacing functions, and with a solid scientific background, the Registry & Results Disclosure Lead enables proper and timely disclosure of trial information in full understanding of medical context.Main Responsibilities
  • Managing trial protocol registrations and coordinating results reporting on ClinicalTnals.gov & EudraCT within mandated timeframes; completing initial data entry based on protocol working in close collaboration with study teams; managing day-to-day collaboration with vendor(s) as required;
  • Coordinating review and approval of study Disclosure Plan & Results Master Document by relevant stakeholders;
  • Extracting information from clinical trial management system databases at regular intervals and updating study records on registries as required; updating study records with links to product labels & citations of publications;
  • Serving as Initial Point of Contact with the National Library of Medicine QA Group to resolve questions prior to public release of data on ClinicalTnals.gov;
  • Updating project tracking systems, maintaining complete, accurate & consistent records reflecting entry of data onto registries; archiving related documentation;
  • Developing and maintaining efficient working relationships with contributing departments (e.g., Clinical Project Management, Statistics, Medical Writing, Regulatory Affairs, Safety)
  • Supporting local teams/vendors responsible for data entry into local registries to ensure consistency of trial information disclosed across national registries;
Candidate Requirements
  • Master’s degree preferred
  • Comprehensive experience m/with clinical development, preferably trial &/or data management &/or biostatistics, or Regulatory Affairs (which could also have been acquired through academia)
  • Experience with – or capability to identify, analyze & apply – relevant regulations & guidelines applicable to clinical research
  • Data-driven; attention to detail
  • Excellent communication/interpersonal skills; ability to work effectively with multidisciplinary & international teams
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Deadline: 09-06-2024

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