An exciting opportunity has arisen for a [Clinical Trial Disclosure Associate to join a global biopharmaceutical company based in the US. A very patient focused company, who scientific research has resulted in 15 marketed products that are benefitting hundreds of thousands of people, a pipeline of late-stage drug candidates and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them.
Under close supervision, conducts disclosure 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
- EMA Policy 0070 and associated Regulations
- Disclosures processes and tools.
- Acquires basic knowledge of regulatory document timelines and the Disclosures & Policy 0070
- Disclosures work is performed under the close supervision of more senior staff following detailed instructions with well-defined procedures.
- Registration of new Clinical Trials on CTgov
- Regular updates to Protocol Records on CTgov
- Results Posting for Clinical Trials on CTgov and EudraCT
- Policy 0070 work is performed under the close supervision of more senior staff following detailed instructions with well-defined procedures.
- Collection, e-organization/e-filing, and tracking of Policy 0070 required documents
- Extraction and preparation of Policy 0070 required documents
- Draft Auto-Redaction and Manual Redaction of Policy 0070 documents
- Facilitation of Policy 0070 review process
- Finalization and publication of Redacted documents
- Preparation of other Policy 0070 materials (e.g. CCI Justification Tables, Anonymization Report, Cover Letter, Document Inventory, etc.)
- Performs QC/editing reviews of documents such as CSRs, IBs, CTDs, and other Clinical or Regulatory documents in line with internal document standards.
- Has strong organization skills and attention to detail, along with ability to work on a number of projects with tight timelines is required.
- Attends and participates in routine group meetings. May attend cross-functional meetings under the direction of a more senior staff meeting.
- Has excellent verbal and written communication skills and interpersonal skills.
- Has well developed computer skills including proficiency in Word, Adobe and Excel.
- 2+ years of relevant experience and a BS degree.
- Clinical R&D experience (e.g. Clinical Operations)
- Basic understanding of Clinical Development and associated regulations (e.g. FDA, EMA) & best practices (e.g. ICH, GCP)
- Disclosures experience (Clinical Trial Registration & Results Posting)
- Policy 0070 experience
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Christopher Frank on +1 267 405 6996 or upload your CV on our website www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.