Clinical Trial Results Manager

Bristol-Myers Squibb Co; Hyderabad; Remote; INR 1,100,000 - 1,900,000; Full time

Job summary

Bristol-Myers Squibb Co is seeking a Clinical Trial Results Manager to oversee data disclosure, reporting forms, and approvals for clinical trial results. The role collaborates with statisticians, physicians, and legal teams to ensure accuracy and regulatory compliance across multiple trial documents.

The position emphasizes data privacy, quality control, and coordination with internal stakeholders to publish CSR summaries and updates.

Qualifications

• Demonstrated Excel and analytical skills.
• Bachelor’s degree in a life science field with 2+ years of technical or preferably scientific writing experience.

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.

Skills

Excel

Analytical skills

Education

BS/MS/PhD in life sciences

Job description

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

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

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/.

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1607639 : Clinical Trial Results Manager Data Privacy Link

We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.