Essential Functions
1. Provides clinical registry support, oversight, and/or accountability for one or more development programs for clinical trials.
2. Takes a leadership role with the clinical development team and other internal and external partners to establish, align, and confirm clinical registry expectations for assigned trial(s).
3. Responsible for submission of approved documents and content to registries worldwide. Submissions are made by the Clinical Registry Administrators.
4. Responsible for tracking, reporting, and documentation of disclosure records and associated documents in tools and systems used by the clinical registry group.
5. Assists business partners, external partners, and local operating companies in maintaining accurate and correct (source) data relevant to the disclosure process.
6. Ensures timely resolution of planning issues to ensure compliant delivery of the disclosure planning.
7. Ensures deliverables are on time.
Qualifications
8. A minimum of 4 years of relevant pharmaceutical/scientific experience in a clinical development environment (pharmaceutical, medical device, CRO, or other clinical development service organization) is required.
9. Bachelor’s degree in Health or Science discipline is required with experience in clinical research
10. Clinical Registry experience preferred.
11. Experience working on a clinical trial or regulatory document management preferred.
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