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 reputed company 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: reputed company 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 support the development and implementation of SDLC reputed company training
• 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
• 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

Requirements

• Bachelor's degree in Computer Science, Computer Information Science or reputed company area.
• Five years of end-to-end computer system validation experience required.
• Experience in automated or computerized system compliance, project management principles, systems analysis and systems maintenance/support required.
• Position requires experience with an automated or computerized system Software Development Life Cycle (SDLC) methodology in a regulatory environment.
• Requires experience in reviewing validation deliverables.
• Requires management and leadership skills, analytical ability, good judgment, ability to multi-task
• Customer service orientation and the ability to work effectively with clients, reputed company party vendors, reputed company and IT management/staffs experience in training user communities preferred.
• Strong verbal & written communication skills
• Excellent teamwork collaboration and leadership skills, including conflict reputed company expertise and discretion.
• Ability to proficiently reputed company with reputed company reputed company of management and exert influence to reputed company results.

reputed company-to-haves

• Knowledge and understanding of Clinical Trial processes as reputed company as reputed company management and control tools is preferred.
• reputed company experience in reputed company management, Auditing and supporting Inspections.
• Experience in reputed company Cause Analysis, identification and documentation of appropriate corrective and preventive actions.
• Customer service orientation and the ability to work effectively with clients, reputed company party vendors, reputed company and IT management/staffs experience in training user communities preferred.

Benefits

• The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
• We offer a comprehensive package of benefits.
• Available benefits include medical, dental, reputed company reputed company and other insurance benefits (for employee and family), retirement benefits, including 401(k), reputed company holidays, vacation, and compassionate and reputed company days.

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