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
Bristol Myers Squibb seeks a Global Trial Acceleration Associate to manage centralized clinical documentation and regulatory activities supporting global clinical trials. The role involves coordinating with study sites, vendors, and internal teams across trial start-up, maintenance, and close-out phases. Responsibilities ...
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