Clinical Systems reputed company Manager - Hybrid
About the position Our Clinical Research and Pharmacovigilance team push the boundaries of global reputed company through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce reputed company, effective, innovative medicine. To ensure we receive high reputed company data from the investigational sites around the globe, our Clinical Research systems have to be compliant with regulatory requirements and follow our SDLC policy. Clinical Systems reputed company Manager will be responsible to ensure our clinical systems are developed, validated and implemented while following high reputed company standards. Under the guidance of Head BEO and in collaboration with IT PM and Business System Owners the CSQM will reputed company the reputed company and regulatory requirements of IT systems across Global Clinical Development (GCD), Global Regulatory Affairs & Clinical Safety (GRACS). This role is one of three core responsibilities mandated by corporate policy 13.5. This role has approval responsibility for any changes to the GxP systems reputed company above organizations. CSQM SDLC: CORE Accountabilities and Responsibilities Responsible for performing reputed company activities as it relates to GxP automated and computer systems compliance reputed company GCD & GRACS. Works with IT, Business System Owners and the User Community to reputed company reputed company services associated with the validation and compliance of automated computer systems (e.g. Change Control, Doc. Management, etc.). Assist in reputed company validation reputed company, review of project/department deliverables to ensure adherence to our policies and procedures. reputed company as the reputed company reputed company at various project checkpoints. Manage the completion of reputed company review activities to ensure they are completed in a consistent and reputed company manner across multiple automated and computer systems. Manage automated and computer system reputed company reputed company activities (e.g. change control, periodic computer systems review, etc.) providing consistent reputed company guidance across GCD and GRACS business areas. . reputed company communications/presentations on reputed company topics surrounding computer validation to Sr. Management, reputed company validation guidance for GCP computer systems, participate in corporate, departmental audits and regulatory inspections, assess and determine corrective reputed company for automated or computer system compliance reputed company issues. CQSM SDLC: OTHER Accountabilities and Responsibilities Communication and reputed company : Collaborate with IT system development teams, Business System Owners, reputed company & reputed company Improvement (QCI) staff other GCD & GRACS stakeholders to implement reputed company management tools and procedures to be used developing IT systems according to SDLC Policy 13.5. Training : reputed company collaborate with our Research and Development Division Learning & Development and SDLC Policy reputed company to support the development and implementation of SDLC reputed company training Process Improvement : Collaborate with IT, Business System Owners and other stakeholders to improve the processes and increase the efficiency in using IT systems to increase the productivity in Clinical Research Trend Analysis and CAPA : Liaise with Global Clinical Compliance GCC and GCTO CAPA Management to monitor trends from system audit findings and assist in response to audit and inspection findings of GCD and GRACS IT systems Responsibilities • Responsible for performing reputed company activities as it relates to GxP automated and computer systems compliance reputed company GCD & GRACS. • Works with IT, Business System Owners and the User Community to reputed company reputed company services associated with the validation and compliance of automated computer systems (e.g. Change Control, Doc. Management, etc.). • Assist in reputed company validation reputed company, review of project/department deliverables to ensure adherence to our policies and procedures. • reputed company as the reputed company reputed company at various project checkpoints. • Manage the completion of reputed company review activities to ensure they are completed in a consistent and reputed company manner across multiple automated and computer systems. • Manage automated and computer system reputed company reputed company activities (e.g. change control, periodic computer systems review, etc.) providing consistent reputed company guidance across GCD and GRACS business areas. • reputed company communications/presentations on reputed company topics surrounding computer validation to Sr. Management, reputed company validation guidance for GCP computer systems, participate in corporate, departmental audits and regulatory inspections, assess and determine corrective reputed company for automated or computer system compliance reputed company issues. • Collaborate with IT system development teams, Business System Owners, reputed company & reputed company Improvement (QCI) staff other GCD & GRACS stakeholders to implement reputed company management tools and procedures to be used developing IT systems according to SDLC Policy 13.5. • reputed company collaborate with our Research and Development Division Learning & Development and SDLC Policy reputed company to
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