Clinical Trial Results Manager
Bristol-Myers Squibb · Hyderabad · onsite · Posted 5d ago
Undisclosed3–8 yrsfulltimeSourced from
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About this role
Key Responsibilities
Requirements
Ideal Candidates Would Also Have
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.
- 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.
Sourced from naukri
Skills
drug developmentanalytical thinkingLIFESCIENCEclinical researchdata privacylosoperational supportbsCSRclinical study reportPLSXMLResearchcompliance
About Bristol-Myers Squibb

Bristol-Myers Squibb
Pharma
375
employees
1887
139 years old
New York
United States
₹19.1L PA avg
Avg at Bristol-Myers Squibb
About
We are a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. At Bristol Myers Squibb, we work every day to transform patients’ lives through science. We combine the agility of biotech with the reach and resources of an established pharmaceutical company to create a global leading biopharma company powered by talented individuals who drive scientific innovation.
We have the brightest people in the industry and believe that their diverse experiences and perspectives help to bring out our best ideas, drive innovation and achieve transformative business results. Each day, our employees around the world work together for patients – patients are at the center of everything we do. They inspire us. They are the reason we come to work each day.
We are proud of the advancements we have made in oncology, hematology, immunology, and cardiovascular disease, and we are dedicated to helping patients prevail over serious diseases through our diverse and promising pipeline and new scientific platforms. We are pursuing therapies at the forefront of scientific discovery with the goal of bringing an exciting new generation of life-changing treatments to patients. We aspire to be at the center of a vibrant healthcare innovation ecosystem, where academic research centers, biotech, and biopharma companies all contribute to continued scientific advancement.
Industries
PharmaBiotech & Life sciences
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