Clinical Trial Disclosure Specialist

Employer: Planet Pharma

Primary Job Duties:

• Responsible for writing and maintaining clinical trial registries, such as ClinicalTrials.gov (CT.gov).
• Update and maintain public listings for 100 clinical studies.
• Track study startups and completion dates, be aware of pending triggers for trial listings and results, and determine which studies are exempt from public disclosure.
• Draft and post all new study listings on CT.gov.
• Train affected groups on internal procedures for drafting, approving and document retention of all public disclosures.
• Update SOPs to ensure alignment with current procedures and requirements.
• Keep current with the disclosure requirements of international clinical trial registries, such as the EU Clinical Trials Register.
• Inform and advise company on the implications of new reporting rules and regulations.

Position Requirements

• Proficiency with Microsoft Office Suite applications, including, Word, Excel, PowerPoint.
• Must have a demonstrated track record of meeting deadlines and filling requests to meet clients’ needs.
• Bachelors degree, a knowledge of the pharmaceutical research and development process.
• Candidates must be able to set priorities and work independently.
• Must also be highly attentive to details, be able to adapt to rapidly changing environment, and act in a service oriented manner at all times.

CO candidates may not be considered

The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.