Manager, GCS Business Technology Solutions

Job Description

Are you ready to lead and innovate in the realm of Biopharma Clinical Operations? As a Manager in GCS Business Technology Solutions, youll be at the forefront of designing, developing, and continuously improving processes, systems, and services that drive clinical study delivery. Collaborate with internal and external stakeholders to meet customer needs and enhance the efficiency of clinical studies. Utilize tools like Lean Six Sigma to identify and implement improvements, ensuring optimal end-to-end delivery. Are you prepared to make a difference? Accountabilities: Design, development, implementation, maintenance, continuous improvement, and ongoing customer support. Lifecycle management of all system documents, ensuring compliance with industry regulations and AstraZeneca policies. Effective communication of information and provision of high-quality training materials. Provide training, advice, and end-user support. Engage and influence key partners to drive strategy, development, and continuous improvement. Keep EDC User Accesses updated and oversee periodic reviews. Perform EDC Platform Level Activities for new study setups. Support audit and regulatory inspection planning, preparation, and conduct. Deliver Corrective and Preventive Actions timely and act on data or trends identified through Quality & Risk Management. Promote creative and innovative ideas to drive performance and bring new solutions to customers. Essential Skills/Experience: Bachelor s of Science in an appropriate subject area or equivalent experience. Extensive knowledge of Drug Development within a pharmaceutical or clinical background. High level of business process, technology, and Clinical Study information experience. Demonstrated project management skills to deliver to time, cost, and quality. Ability to collaborate with, motivate, and empower others to accomplish objectives. Experience working successfully with external partners delivering mutual benefit. Excellent written, verbal, influencing skills; negotiation, collaboration, problem-solving, presentation, mentoring, conflict management, interpersonal skills. Experience in Medidata Rave including iMedidata user/site administration, report administration, core configuration, study build/edit check programming. Desirable Skills/Experience: Expert reputation within the business and industry. Experience applying standard process improvement methodologies (e.g., Lean Six Sigma). Experience in development/management of Business Processes for business performance. Comprehensive knowledge of ICH/GCP. Extensive experience in Validation of computerized systems in a regulated environment. Extensive experience of Quality Systems and Quality Management. Medidata Study Builder certification. Experience in other EDC systems (e.g., Veeva, Bioclinica). Experience in other Medidata products including Rave EDC, Site Cloud, Medidata Coder. Experience working within agile environment using JIRA.