Clinical Trial Transparency Specialist
4 weeks ago
We are seeking a skilled Clinical Trial Transparency Specialist to join our team at Genmab.
About the Role:
This role will be responsible for executing against global and national clinical trial disclosure requirements across our entire portfolio. You will support trial teams and applicable functions to ensure high-quality output and responsible disclosure of clinical trial information.
Your Key Responsibilities Will Include:
- Managing public disclosure of clinical trial protocols, results, and redacted documents.
- Developing and maintaining timelines for authoring protocol registration and results disclosure activities on ClinicalTrials.gov and other registries.
- Autoring/plain language results summaries.
- Developing SOPs, templates, and overseeing system implementations.
- Training internal staff/vendors on applicable disclosure processes.
- Monitoring industry guidelines to ensure compliance.
Requirements:
To be successful in this role, you will need:
- A minimum of a bachelor's degree.
- 5+ years of pharmaceutical industry experience with good understanding of clinical development.
- Excellent written and verbal communication skills.
- Previous experience with clinical trial disclosure is strongly preferred.
About You:
You will be an engaged colleague with a positive and collaborative mindset, goal- and improvement-oriented, and committed to contributing to our overall success. This role can be located in Copenhagen DK or Utrecht NL and is hybrid.
Estimated Salary: $120,000 - $150,000 per annum, depending on location and experience.
About Us:
Genmab is committed to transparency of clinical trial research and recognizes the scientific and ethical value of sharing clinical trial information in a non-biased and timely manner. We are expanding our Clinical Trial Disclosure & Transparency team and are looking for talented individuals to join us.
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