- Identifies result summary data to be disclosed based on the protocol and study report.
- Creates the results reporting form for a clinical trial based on information found in the clinical study report.
- Manages the review and approval process for the results form, uploads completed and approved forms to ClinicalTrials.gov and EudraCT/CTIS.
- Partners with DQS and external partners to ensure AE xml files for results disclosure are created and uploaded to the database.
- Files reporting extensions (certificates of delay) when appropriate.
- Liaises with Statisticians, Clinical Trial Physicians, Patent Attorneys, Global Trial Manager, and Medical Writers on all trials - operates as part of team to ensure the data best supports results and is consistent with other public forms of trial results (i. e. publication in a clinical journal)
- Provides operational support for other pillars of Clinical Trial Transparency, as needed
- Assesses revised protocols for impact on registration, and works with the study team on registration updates.
- Publishes CSR synopsis on BMS.com
- Contributes to improvements of clinical trial data disclosure processes and related documentation.
- Support Plain Language Summary (PLS) activities, as needed.
Requirements
- BS, MS, or PhD in scientific or medical field
- Minimum of 3 years overall work experience
- Demonstrated Excel and analytical skills
- Bachelor s degree in a life science field with 2+ years of technical or preferably scientific writing experience
Ideal Candidates Would Also Have
- Work experience in quality, regulatory, compliance, clinical research or drug development, clinical research preferred
- Familiarity with clinical trial protocols and reports desirable
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