Clinical Trial Transparency

hace 4 meses

Unión Murcia provincia, España Argenx A tiempo completo

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 in-depth knowledge of the fast-evolving 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, Clinicaltrials.gov 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
- Multi-tasks and prioritize effectively in fast-paced environment
- Highly self-motivated
- 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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