Bristol Myers Squibb (BMS) is a global biopharmaceutical company dedicated to transforming patients’ lives through science. With a commitment to diversity, innovation, and excellence, BMS delivers life-changing solutions by leveraging cutting-edge research and fostering a culture of collaboration. Employees thrive in an inclusive environment that offers unparalleled growth opportunities and meaningful work that impacts the world.
Job Responsibilities
As an Associate Clinical Trial Monitor at BMS, you will play a pivotal role in overseeing the progress of clinical trials. Key responsibilities include:
- Site Engagement and Evaluation: Identifying and assessing potential investigators and their sites to ensure suitability for clinical trials.
- Training and Support: Conducting pre-study and initiation visits to provide protocol-specific training and ensure site readiness.
- Monitoring Activities: Reviewing site activities through on-site and remote visits, ensuring adherence to protocols, Good Clinical Practice (GCP), and regulatory requirements.
- Data Oversight: Ensuring the completeness and quality of submitted data and maintaining up-to-date eCRF entries.
- Relationship Management: Building and maintaining strong relationships with site personnel and motivating them to meet study objectives.
- Compliance and Reporting: Addressing regulatory compliance issues, preparing detailed reports, and supporting audit processes as required.
- Coordination and Support: Assisting with Ethics Committee submissions, ICF reviews, document collection, system access, equipment calibration, and study initiation material preparation.
Qualifications and Experience
To qualify for this role, candidates should possess the following:
- Education: Bachelor’s degree, preferably in life sciences or an equivalent field.
- Experience: At least 1 year of relevant clinical research experience with the ability to work independently.
- Skills:
- Strong analytical and decision-making capabilities.
- Excellent interpersonal and communication skills.
- Ability to manage multiple protocols across therapeutic areas.
- Proficiency in ensuring regulatory compliance and quality data submission.
Skills and Competencies
- Knowledge of ICH/GCP Guidelines and local regulations.
- Proficiency in clinical trial monitoring tools and systems.
- Strong organizational and time-management abilities.
- Flexibility and adaptability in communication with diverse stakeholders.
- Problem-solving skills to proactively address site issues.
