Notes:
- Focused on new registration, updates, PRS systems, clinical trial.gov.
- 2+ Years of experience in CLINICAL TRIAL DISCLOSURE & TRANSPARENCY ASSOCIATE.
- 3-5 yrs in Biometrics, clinical operations, data management.
- Requisite knowledge of clinical trial process.
- Clinical Trial Manager, Clinical Data Manager, Clinical Trial Monitor – depends on strength of analytical skills.
- Heavy work load – growing pipeline and requirements that are associated with disclosures and transparency.
- Publication of documents.
- Revoking of ICH 6 and ICH 8.
- Nimble, work independently, hope they take on greater responsibility in the future.
- Preference is local to the bay area but not a strict requirement, open to remote workers.
CLINICAL TRIAL DISCLOSURE & TRANSPARENCY:
The Disclosure &Transparency function resides organizationally within Medical Writing The Disclosures function is responsible for clinical trial registrations and result postings in ClinicalTrials.gov and the EU Clinical Trial Register. Disclosures is also responsible for the EMA Policy 0070 (Publication of Clinical Data and Reports) activities.
PROJECT INVOLVEMENT:
Does not participate formally in cross functional teams, but may attend team meetings under direction of a more senior staff member.
K
KEY CONTRIBUTIONS:
- Under close supervision, conducts Disclosures activities including:
- Registration of Clinical Trials on CTgov
- Results Posting of Clinical Trial Results on CTgov and EudraCT
- Extraction of required documents for Policy 0070
- Redaction of documents for Policy 0070
- Gains foundational understanding of industry regulations and guidances
- FDA and EMA Regulations regarding Registration of Clinical Trials
- FDA & EMA Regulations regarding Results Posting of Clinical Trials