R&D Clinical Development VP, NA

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 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 About Capgemini Invent As the digital innovation, design and transformation brand of the Capgemini Group, Capgemini Invent enables CxOs to envision and shape the future of their businesses. Located in more than 36 offices and 37 creative studios around the world, it comprises a 10,000 strong team of strategists, data scientists, product and experience designers, brand experts and technologists who develop new digital services, products, experiences and business models for sustainable growth. Capgemini Invent is an integral part of Capgemini, a global leader in partnering with companies to transform and manage their business by harnessing the power of technology. The Group is guided everyday by its purpose of unleashing human energy through technology for an inclusive and sustainable future. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, cloud and data, combined with its deep industry expertise and partner ecosystem. The Group reported 2023 global revenues of €22.5 billion. Get The Future You Want Disclaimer Capgemini is an Equal Opportunity Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, national origin, gender identity/expression, age, religion, disability, sexual orientation, genetics, veteran status, marital status or any other characteristic protected by law. This is a general description of the Duties, Responsibilities and Qualifications required for this position. Physical, mental, sensory or environmental demands may be referenced in an attempt to communicate the manner in which this position traditionally is performed. Whenever necessary to provide individuals with disabilities an equal employment opportunity, Capgemini will consider reasonable accommodations that might involve varying job requirements and/or changing the way this job is performed, provided that such accommodations do not pose an undue hardship. Capgemini is committed to providing reasonable accommodations during our recruitment process. If you need assistance or accommodation, please reach out to your recruiting contact. Click the following link for more information on your rights as an Applicant Please be aware that Capgemini may capture your image (video or screenshot) during the interview process and that image may be used for verification, including during the hiring and onboarding process. Applicants for employment in the US must have valid work authorization that does not now and/or will not in the future require sponsorship of a visa for employment authorization in the US by Capgemini. #LI-DH1 Job: Organization: INVENT PEOPLE Title: R&D Clinical Development VP, NA Location: IL-Chicago Requisition ID: 076324

Created: 2024-10-23