Clinical Trial Job at Bristol Myers Squibb

Are you a scientist or medical professional interested in clinical trial results? Bristol Myers Squibb is seeking a Clinical Trial Results Manager to join its team in Hyderabad. This full-time role centres on creating results reporting forms from clinical study reports and managing their review and approval. The Clinical Trial Job also involves uploading approved forms to ClinicalTrials.gov and EudraCT/CTIS and working with statisticians, clinical trial physicians, and medical writers. Candidates should hold a BS, MS, or PhD in a scientific or medical field and have at least 3 years of overall work experience.

About Bristol Myers Squibb:

At Bristol Myers Squibb, employees often ask, “Who are you working for?”, a question that fuels collaboration, accountability, and urgency in the work. The purpose-driven culture inspires the organisation to discover, develop, and deliver innovative medicines to prevail over serious diseases. Bristol Myers Squibb offers 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.

Job Details:

Job Title: Clinical Trial Results Manager
Location: Hyderabad – TS – IN
Job Type: Full-time
Posted: Today
Job Requisition ID: R1607639

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, working as part of a team to ensure the data best supports the results and is consistent with other public forms of trial results (e.g., 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.
Supports Plain Language Summary (PLS) activities, as needed.

Eligibility Criteria for the Clinical Trial Job:

Medical or a relevant 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

Required Skills for the Clinical Trial Job:

Work experience in quality, regulatory, compliance, clinical research or drug development, clinical research preferred
Familiarity with clinical trial protocols and reports desirable

Clinical Trial Job at Bristol Myers Squibb, Hyderabad | Medical Professionals Are Welcome!