R&D Clinical Development VP, NA
2 months ago
Description
Job description:
KEY RESPONSIBILITIES:
Drive strategic and process reengineering initiatives to transform and optimize clinical operations workflows and enhance data management efficiency. Will be instrumental in managing changes related to data, analytics, technology, and process, ensuring seamless adoption and alignment with organizational objectives. Lead, direct, sell, and deliver North America Invent R&D Clinical Development business, interacting closely with Invent Global Clinical and the broader Capgemini organization.Primary responsibility in 2024 to develop and grow this business for Capgemini from a Management Consulting perspective. Lead and manage end-to-end implementation projects of Clinical Solutions for clinical research /Biopharma /MedTech organizations, from planning and execution to monitoring and delivery, ensuring adherence to timelines, budgets, and quality standards. Collaborate with external stakeholders, including Clinical Operations and/or Clinical Data Management, to gather requirements and define project scopes for technology implementation and business process reengineering initiatives. Develop comprehensive project plans, including resource allocation, risk assessment, and mitigation strategies, to drive successful execution. Coordinate with internal stakeholders and partners to facilitate the implementation of Clinical Solutions and ensure a smooth implementation process. Identify opportunities for process optimization and reengineering to enhance clinical operations, data collection, and analysis efficiency. Champion change management efforts, including communication, training, and support, to drive user adoption and maximize the benefits of implemented solutions. Establish and maintain effective communication channels with project team members, stakeholders, and senior management to provide regular updates and manage expectations. Monitor project progress, identify deviations from the plan, and proactively resolve issues to keep projects on track. Ensure compliance with regulatory requirements, industry standards, and best practices in all project activities, with a strong focus on Good Clinical Practice (GCP) guidelines. Continuously evaluate the performance and impact of implemented Clinical Solutions, seeking feedback from end-users, and implementing iterative improvements as needed.Required Skills:
Basic Qualifications:
Bachelor's degree or higher in a relevant scientific or technical field. Proven experience (10+ years) as a Vice President and Project Manager in the pharmaceutical, biotechnology, or clinical research industry, with a strong background in Clinical Operations. Demonstrated experience and ability (5+ years, within the last 5 years) to be a successful executive in a large cross-functional Consulting Organization. Demonstrated expertise in managing technology implementation projects, particularly Clinical Solutions such as Electronic Data Capture (EDC) systems, Clinical Trial Management Systems (CTMS), and related tools. Comprehensive understanding of clinical research processes, biostatistical environment and regulatory guidelines (e.g., ICH-GCP) governing clinical trials. Strong leadership, communication, and interpersonal skills, with the ability to build and lead cross-functional teams effectively. Excellent analytical and problem-solving abilities, with a keen eye for identifying opportunities for process optimization and reengineering. Project Management Professional (PMP) certification is a plus. Familiarity with software development life cycle (SDLC) and Agile methodologies is an advantage.Life at Capgemini
Capgemini supports all aspects of your well-being throughout the changing stages of your life and career. For eligible employees, we offer:
Flexible work Healthcare including dental, vision, mental health, and well-being programs Financial well-being programs such as 401(k) and Employee Share Ownership Plan Paid time off and paid holidays Paid parental leave Family building benefits like adoption assistance, surrogacy, and cryopreservation Social well-being benefits like subsidized back-up child/elder care and tutoring Mentoring, coaching and learning programs Employee Resource Groups Disaster Relief
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