Qualifications and Experience• Degree in Mathematics (i.e., Applied Math, Engineering, etc), Statistics, Computer
Science, Life
Science or equivalent
• Proven programming expertise
• Thorough knowledge of the clinical development process
• Thorough knowledge of industry standards and ability to implement them
• Ability to apply programming expertise to problem solving and troubleshooting for
teams
Responsibilities
• Leads and directs the full scope of project delivery and/or leads a technical project within the
TA/Drug Project/study/function
• Leads Implementation of statistical programming aspects of the protocol or clinical development
program
• Responsible for the high quality of all project deliverables, holding partners and providers
accountable for the quality of their deliverable and/or technical subject matter expert for
aspect(s) of the TA, Project, or function
• Leads or contribute to cross-functional administrative or process improvement initiative(s)
• Drives the development of best practices to improve quality, efficiency and/or effectiveness within the function
• Drives standards development and implementation
• Manages and escalate risk in complicated or novel situations within their study and/or projects
• Provides Programming expertise to the team
• Provides tactical input and/or drives ideas and improvements
• Contributes to the function by supporting recruiting and/or providing training and mentorship
• Identifies opportunities to improve methodology and provides practical solutions for problems
• Influences stakeholders by providing subject matter expertise on programming related items
• Ensures compliance to standards and automation usage
• Employs all project management practices in managing drug or technical projects
• Provides input to capacity management for all projects in scope
• Maintains expertise of the latest industry and regulatory requirements to stay current
Best regards,
Venkatesh M
Amtex System Inc
“Certified MBE firm”
28 Liberty Street, 6th Floor, New York, NY 10005
646 200 7212
venkatesh.maddela@amtexsystems.com | www.amtexsystems.com
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