Principal

• Draft, review and negotiate site agreements including clinical study agreements, service agreements, and team member agreements
• Provide context to comments received from sites based on legal and business framework
• Manage the contract execution process
• Develop and maintain positive relationships with clinical trial sites
• Track and report on the statuses of site contracting activities

Principal Site Contracts Associate handling site agreements in clinical development

Principal Site Contracts Associate

Principal Site Contracts Associate handling site agreements and managing contractual processes in clinical development. Engaging with clinical trial sites and ensuring compliance with local regulations and guidelines.

• Designs and develops efficient programs and technical solutions in support of highly complex/critical clinical research analysis and reporting activities, including urgent/on-demand analysis requests.
• Provides technical and project specific guidance to programming team members to ensure high quality and on-time deliverables in compliance with departmental processes.
• Coordinates and oversees programming team activities and may provide matrix leadership to one or more programming teams as needed.
• Shares knowledge and provides guidance and coaching to programmers in developing advanced technical and analytical abilities.
• Performs comprehensive review of, and provides input into, project requirements and documentation.
• Collaborates effectively with programming and cross-functional team members and counterparts to achieve project goals and independently manages escalations.
• As applicable, oversees programming activities outsourced to third party vendors adopting appropriate processes and best practices to ensure their performance meets the agreed upon scope, timelines, and quality.
• Responsible for adoption of new processes & technology on assigned projects/programs in collaboration with departmental technical groups and programming portfolio leads.
• Contributes to and may lead departmental innovation and process improvement projects and may contribute programming expertise to cross functional projects/initiatives. May play the role of a Delivery Unit/Disease Area Expert.
• Ensures continued compliance of project/programs and required company and departmental training, time reporting, and other business/operational processes as required for position.

Principal Statistical Programming Lead for healthcare innovation at Johnson & Johnson

Principal Statistical Programming Lead

Principal Statistical Programming Lead at Johnson & Johnson in India. Developing solutions for complex clinical research analysis and reporting, leading programming teams and ensuring deliverable quality.

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Principal Site Contracts Associate

Principal Statistical Programming Lead