Clinical Trial Transparency - Unión, Murcia provincia, España - Argenx

Argenx
Argenx
Empresa verificada
Unión, Murcia provincia, España

hace 3 semanas

Isabel García

Publicado por:

Isabel García

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Descripción
The clinical trials transparency and disclosure associate is responsible for the transparency activities at argenx: protocol registration, result posting and anonymization and/or redaction of documents

The position will report into the Clinical Trials Transparency and Disclosure Lead.


Roles & Responsibilities:

  • Maintain an indepth knowledge of the fastevolving global transparency and disclosure regulations
  • Coordinate and contribute to global disclosure and transparency deliverables in accordance with the company transparency policy:
  • Initiate and maintain clinical trial registration in various global trial registries (ie, and CTIS)
  • Coordinate the result posting in various global trial registries and the creation of plain language summaries
  • Manage the redaction of clinical trial documents in accordance with global regulations
  • Manage and Coordinate redaction of clinical documents in accordance with EMA Policy 0070, Health Canada Public Release of Clinical Information (PRCI), EU Clinical Trial Regulation, and other global regulations.
  • Provide vendor oversight to support anonymization, data sharing, redactions and lay summaries preparation, as appropriate
  • Assist in coordinating significant workstreams that involve work across departments and/or with external vendors
  • Provide support and/or lead transparency activities as directed.
  • Assist transparency efforts and operations.
Skills, Competencies & Experience

  • Excellent written and oral communication skills
  • Computer literacy, proficiency in MS Word, Excel, PowerPoint etc
  • Excellent organizational skills and attention to detail
  • Working knowledge of Adobe Acrobat Pro
  • High learning attitude and adaptability
  • Multitasks and prioritize effectively in fastpaced environment
  • Highly selfmotivated
  • Team player who seeks to help and learn from colleagues seeing the department success as their own
  • A problem solver and critical thinker that relies on own judgment for appropriate level of decision making
  • Education:
  • At least a Bachelor degree in scientific or biomedical field
  • Experience:
  • 2+ years of experience in similar position
  • Experience in and understanding of global clinical trial transparency regulations
  • Familiarity with clinical trial documents and knowledge of clinical study and clinical development design
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