Provide regulatory expertise to R&D, Franchise and Commercial Operations for assigned products/projects, leading regulatory strategy and ensuring compliance worldwide.
Responsibilities
Provide regulatory expertise to R&D, Franchise and Commercial Operations
Act as interface between R&D/Franchise/Operations and GRA on regulatory issues
Execute development and flawless execution of regulatory strategies for assigned products/projects
Lead operational excellence initiatives within GRA
Contribute to drafting of regulatory strategy documents
Clinical Trial Manager responsible for coordinating country cross functional teams, acting as the main point of contact for the country, and managing clinical trial strategies and timelines.
Responsibilities
Coordinates country cross functional teams and acts as the main point of contact for a Country with the protocol manager and other global study team members
Coordinates with other internal roles in country and site feasibility process, including proposal and validation of country study targets
Develops country level patient recruitment strategy & risk mitigation. Coordinates and ensures country level study enrolment targets and timelines are met
Leads problem solving and resolution efforts including management of risk, contingencies, issue resolution and escalation to the appropriate stakeholder/s
Assessment and set up the of vendors during study start up period (locally)
Global Study Manager/Lead responsible for end-to-end clinical study delivery, budgeting, risk management, and stakeholder communication across multiple regions.
Responsibilities
Accountable for operational delivery of clinical studies to time, quality, and budget
Generate robust delivery plans and deliver to target thresholds
Lead study team and matrix teams
Develop protocol and informed consent documents
Conduct investigator meetings and other study related meetings
Requirements
Bachelor’s degree in life sciences or related discipline
As a Senior Clinical Trial Coordinator, you'll coordinate and facilitate project activities and may serve as a study lead, acting as a cross-functional liaison for the project team. Provides administrative and technical support.
Responsibilities
Coordinates, oversees and completes functions on assigned trials activities detailed on the task matrix
Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system
Ens allocated tasks are performed on time, within budget and to a high quality standard
Proactively communicates any risks to project leads and line manager
Supports the maintenance of study specific documentation and global support with specific systems, tools and trackers (study team lists, training requirements, system access, project level activity plans)
comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability)
Clinical Trial ManagerNewBristol Myers Squibb · Bangkok, Thailand