Bristol Myers Squibb (BMS) is a leading global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients overcome serious diseases. The company is renowned for its groundbreaking research and development in oncology, immunology, cardiovascular, and hematology. With a strong focus on scientific excellence, BMS offers a dynamic work environment where employees can thrive and contribute to life-changing medical advancements.
Responsibilities in Job
As a Clinical Trial Manager, you will be responsible for the oversight and delivery management of clinical studies at the country level. The key responsibilities of this role include:
- Acting as the main point of contact for internal and external stakeholders.
- Leading country cross-functional teams and coordinating study activities with the global study team.
- Managing study start-up, patient recruitment, and ensuring study timelines and targets are met.
- Ensuring compliance with Good Clinical Practice (GCP), ICH guidelines, and regulatory requirements.
- Coordinating with vendors and overseeing the execution of study contracts and agreements.
- Monitoring site performance, reviewing reports, and ensuring proper documentation.
- Managing budgets and contracts for clinical trial sites and ensuring adherence to financial guidelines.
- Preparing study materials, including Investigator Meeting content and Site Initiation Visit (SIV) documentation.
- Ensuring inspection readiness and compliance with audit requirements.
- Leading site closure activities and coordinating database lock processes.
Qualifications
To be eligible for this role, candidates must meet the following qualifications:
- Bachelor’s degree in Life Sciences or an equivalent field.
- Minimum of 4 years of industry-related experience in clinical research.
- Experience in leading or being an active member of cross-functional teams.
Required Skills
The ideal candidate should possess the following skills and competencies:
- Strong understanding of GCP, ICH guidelines, and regulatory environments.
- In-depth knowledge of clinical research processes and study methodologies.
- Ability to coordinate multiple stakeholders and manage clinical trial activities efficiently.
- Excellent problem-solving skills and the ability to address challenges proactively.
- Strong communication and leadership skills.
- Proficiency in Microsoft Suite, Clinical Trial Management Systems (CTMS), Electronic Data Capture Systems (eDC), and Electronic Trial Master File (eTMF).
