Clinical Trial Transparency Senior Associate

Job Title: Clinical Trial Transparency Senior Associate

Location: Cambridge, MA
Duration: 7+ months (Possibility of extension)

Job Description:
• Performs the Clinical Trial Registration and/or results disclosure activities for new and/or ongoing studies.
• Ensures compliance due dates are defined and timelines are met.
• Collaborates with the Study Team to complete the data entry in support of Clinical Trial Disclosure, utilizing information from source documents and systems (e.g. protocol, CTMS).
• Assigns tasks, initiates workflows, follows up on all action required, and escalates alerts when needed in order to maintain content that has been made public (e.g. clinicaltrials.gov).
• Shares accurate information with various functional leads to be utilized throughout global disclosures
• Performs internal quality control review of disclosure information.
• Participates in User-Acceptance Testing (UAT) of disclosure system.
• Supports process analysis efforts by identifying opportunities to improve the efficiency and effectiveness of the Clinical Trial Disclosure process.
• Generates metrics for disclosure activities.
• Supports the development and delivery of training materials.

Requirements:
• Firm understanding of Clinical Development and operations.
• Previous experience (2-3 years minimum) in pharma/biotech industry.
• Must have previous experience disclosing clinical trial information on ClinicalTrials.gov.
• Minimum education of Bachelor Degree (or equivalent experience).
• Experience with PharmaCM would be a plus.