Vacancy description
Sr. Global Trial Acceleration Associate in Hyderabad, भारत
Bristol Myers Squibb
Hyderabad, भारत
Bristol Myers Squibb seeks a Senior Global Trial Acceleration Associate to manage centralized clinical operations activities across global studies. The role involves independent execution of trial start-up, regulatory submissions, site coordination, and compliance activities with increased autonomy and accountability.
Responsibilities
- Independently manage clinical trial start-up and regulatory activities across assigned studies with limited supervision
- Prepare, review, and coordinate clinical trial packages and Ethics Committee submissions in compliance with regulations
- Manage country and site-level informed consent form adaptations and investigator file maintenance
- Process site-level financial activities, purchase orders, and insurance coordination
- Identify operational risks and delays, coordinating timely resolution with internal and external stakeholders
Requirements
- Bachelor's degree in legal, life sciences, business administration, or equivalent experience
- 5-8 years of clinical development and operational experience in pharmaceutical, biotech, or CRO
- Hands-on experience preparing and submitting regulatory documentation to IRBs and regulatory agencies
- Hands-on experience with clinical study start-up and activation documentation
- Knowledge of GCP, applicable regulations, and inspection standards
- Strong cross-functional collaboration and communication skills