Basking Ridge, NJ, 07920, USA
18 hours ago
Clinical Supplies Manager
Job Title: Clinical Supplies Manager Job Description This position is responsible for managing Interactive Response Technology (IRT)-related activities across multiple clinical trials and/or at the vendor level according to Good Clinical and Manufacturing Practices (GCP, GMP), and standard practices. A successful candidate will be responsible for providing subject matter expertise in IRT while driving the development and delivery of IRT systems across global matrixed teams. Manage and coordinate IRT-related activities and timelines during study initiation, start-up, conduct, closeout, and archival. These activities will include: • Providing input into the Request for Proposal (RFP) process and protocol development process for assigned clinical trials; • Managing and contributing to the IRT system development lifecycle, including requirements gathering, user acceptance testing, issue management, change management, and decommissioning activities, to minimize unanticipated impacts across programs and stakeholders; • Supporting transparency in operational planning through tracking IRT-related milestones and dashboard inputs; and • Ensuring inspection readiness of IRT-related items for assigned clinical trials • Conducting oversight of assigned IRT vendors, ensuring timelines and data quality standards are met. • Supporting compliance audits, IRT vendor audits and regulatory submissions and/or contributing to cross-functional and global improvement projects including IRT-related data and/or IRT vendors. Hard Skills + Good Clinical and Manufacturing Practices (GCP, GMP) + Interactive Response Technology (IRT) + Request for Proposal (RFP) process + Protocol development + Requirements gathering + User acceptance testing + Issue management + Change management Soft Skills + Project management + Vendor management + Operational planning + Compliance auditing + Cross-functional collaboration About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
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