Job Title: Clinical Research Associate
Location: Mumbai, India
Company: Bristol Myers Squibb (BMS)
Summary:
Bristol Myers Squibb (BMS), a leading global biopharmaceutical company, is seeking a highly motivated and experienced Clinical Research Associate (CRA) to join our dynamic team in Mumbai, India. As a CRA, you will play a crucial role in ensuring the integrity and success of clinical trials, contributing to the development of innovative therapies that transform patients’ lives. If you are passionate about clinical research, dedicated to upholding the highest standards of ethics and compliance, and eager to make a meaningful impact on global healthcare, we encourage you to apply.
About Bristol Myers Squibb:
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop, and deliver innovative medicines that help patients prevail over serious diseases. With a commitment to scientific excellence and innovation, we are at the forefront of developing transformative therapies in areas such as oncology, hematology, immunology, and cardiovascular disease. At BMS, we foster a collaborative and inclusive work environment where employees are empowered to make a difference.
Job Description:
As a Clinical Research Associate at BMS, you will be responsible for managing and monitoring clinical trial sites to ensure compliance with study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines. You will work closely with investigators, site staff, and cross-functional teams to facilitate the smooth execution of clinical trials and the collection of high-quality data.
Key Responsibilities:
- Conduct site qualification, initiation, monitoring, and close-out visits in accordance with ICH-GCP guidelines and company Standard Operating Procedures (SOPs).
- Ensure data integrity and protocol compliance at clinical trial sites through regular monitoring activities and proactive problem-solving.
- Support investigators and site staff with training, risk mitigation strategies, and adherence to regulatory requirements.
- Serve as a primary point of contact for assigned clinical trial sites, maintaining effective communication and building strong relationships with site personnel.
- Monitor and reconcile study drug/Investigational Medicinal Product (IMP) inventory, ensuring accurate documentation and accountability.
- Utilize Clinical Trial Management Systems (CTMS), electronic Trial Master Files (eTMF), and Electronic Data Capture (EDC) systems to manage study data and documentation effectively.
- Contribute to audit readiness activities, including preparing for and participating in internal and external audits.
- Leverage centralized and risk-based monitoring tools to identify potential issues and proactively address them.
- Collaborate with cross-functional teams, including clinical project managers, data managers, and medical monitors, to ensure the successful execution of clinical trials.
Qualifications:
- Bachelor’s degree in Life Sciences or a related discipline is required.
- A minimum of 2-3 years of experience as a Clinical Research Associate or in a related clinical research role is essential.
- Prior experience working for a Pharma/Biotech Sponsor or as a Clinical Study Coordinator is preferred.
- Thorough knowledge of ICH-GCP guidelines, local regulations, and clinical trial processes is a must.
- Excellent communication, analytical, and organizational skills are essential for success in this role.
- Proficiency in Microsoft Office suite, CTMS, eTMF, and Electronic Data Capture systems is required.
- Ability to work independently and as part of a team, with a strong focus on quality and attention to detail.
Benefits & Work Culture:
At Bristol Myers Squibb, we are committed to providing our employees with a comprehensive and competitive benefits package that supports their well-being and professional growth. As a valued member of our team, you will enjoy:
- Competitive compensation and performance-based rewards.
- Opportunities for career advancement and professional training.
- An inclusive, diverse, and collaborative work culture that fosters innovation and creativity.
- Exposure to cutting-edge drug development and clinical operations projects that are shaping the future of healthcare.
- A commitment to work-life balance and flexibility.
Work Model:
This is a site-by-design position based in Mumbai, requiring at least 50% on-site presence for collaboration, trial oversight, and to foster strong relationships with the local team.
To Apply:
If you are a highly motivated and experienced clinical research professional seeking a challenging and rewarding opportunity, we encourage you to apply.