Clinical Trial Associate Job Opportunity at Bristol Myers Squibb

Are you passionate about making a difference in the lives of patients through groundbreaking clinical research? Bristol Myers Squibb (BMS), a global leader in biopharmaceutical innovation, is seeking a Clinical Trial Associate to join their dynamic team in Mumbai, Maharashtra. This is a full-time opportunity to contribute to life-changing therapies and grow your career in a diverse and inclusive environment.

About Bristol Myers Squibb

Bristol Myers Squibb is a global biopharmaceutical company committed to discovering, developing, and delivering innovative medicines that help patients overcome serious diseases. With a mission to transform patients’ lives through science, BMS fosters a culture of passion, innovation, urgency, accountability, inclusion, and integrity.

At BMS, you’ll be part of a team that values diversity and empowers employees to bring their unique perspectives to the table. The company offers competitive benefits, flexible work arrangements, and opportunities for professional growth, ensuring a rewarding career and a balanced personal life.

Job Description: Clinical Trial Associate

As a Clinical Trial Associate, you will play a pivotal role in managing clinical trial activities, ensuring compliance with regulatory requirements, and supporting the successful execution of clinical studies. Your responsibilities will include:

Key Responsibilities:

• Study Start-Up and Document Management: Oversee study start-up activities and manage essential clinical trial and regulatory documents.
• Regulatory Submissions: Prepare and submit documentation to Health Authorities (HA) and Ethics Committees (EC), ensuring timely approvals for protocols, amendments, and other required documents.
• Site Readiness: Prepare investigator sites for clinical trials by reviewing and approving essential documents, including Informed Consent Forms (ICF) and Clinical Trial Package (CTP) documentation.
• Collaboration: Work closely with internal study teams, external site staff, and regulatory bodies to align tasks with study timelines.
• Trial Master File (TMF): Ensure the electronic TMF contains all necessary regulatory documents for site activation and ongoing study management.
• Compliance: Maintain a thorough understanding of Good Clinical Practice (GCP), ICH Guidelines, and country-specific regulatory requirements.
• Support Inspections: Assist in Health Authority inspections, audit preparations, and corrective action plans.
• Label Review: Conduct drug/IMP label reviews and translations when applicable.

Qualifications:

• Bachelor’s degree in life sciences or a related field.
• Minimum of 2 years of industry-related experience in clinical research.
• In-depth knowledge of clinical research processes, GCP, ICH Guidelines, and regulatory requirements.
• Strong organizational, time management, and decision-making skills.
• Excellent verbal and written communication skills in English and the local language.
• Ability to manage multiple priorities and think critically to mitigate risks.

Why Join Bristol Myers Squibb?

• Life-Changing Work: Contribute to cutting-edge research that transforms patients’ lives.
• Inclusive Culture: Be part of a diverse and high-achieving team that values inclusion and innovation.
• Career Growth: Access opportunities for professional development and career advancement.
• Work-Life Balance: Enjoy flexible work arrangements and competitive benefits.

How to Apply

Application Link