Key Responsibilities
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

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Clinical Trial Results Manager Hyderabad
🏢 Bristol-Myers Squibb
📍 Hyderabad