System Owner, Associate Director, Global Clinical Solutions
3 weeks ago
System Owner
(SO) is a member of Global Clinical Solutions, Business Technology Solutions (BTS) department and is end-to-end accountable for the leadership, lifecycle management and continuous improvement of Clinical systems. This SO role will be fairly broad and experience in Drug Development Analysis and Reporting processes will be important as the SO will be responsible for a Clinical system or Systems.The System Owner works closely with vendor(s) if applicable, R&D IT (Information Technology), Functional Process Owners, Business Process Management Office (BPMO), internal and external customers and stakeholders to ensure customer needs are met and to enable optimal end-to-end delivery of clinical studies. You will be responsible for the identification, definition and delivery of improvements in end-to-end clinical study delivery, utilising tools and techniques to achieve continuous improvement and value creation (i.e. Lean Six Sigma).The SO ensures that the System meets ICH/GxP requirements and aligns with industry direction, standards, and best practices.The System Owner represents the business interests in strategy discussions and provides strategic advice to the Governance team in securing long-term business success of their assigned system(s). Reviews and approves (if acceptable) identified system risks and mitigations. Controls and prioritizes all business requests, such as those for feature enhancements, ensuring prioritization takes place so resources (staff, vendor budget) are spent on value-add activities. Accountable for communication to key stakeholders and the business regarding the system (major incidents, new releases, etc.)All System Owners will lead and manage improvement projects as needed, and will contribute to functional, regional and or global initiatives.Typical Accountabilities1) System Ownership:As the allocated owner for a specific clinical computerized system:Accountable for the design, development, implementation, maintenance, continuous improvement and ongoing customer support for the allocated areaAccountable for lifecycle management of all procedural or system documents within the allocated area, and for ensuring compliance with applicable industry regulations and AstraZeneca Global and Local PoliciesPlans and prioritizes product feature backlog and development for the productDefines system vision, road-map and growth opportunitiesResearches and analyses the business context, the users, and the roadmap for the assigned systemAccountable for the effective and timely communication of information, and for the development and delivery of high-quality training materials for the allocated areaResponsible to partner with and for providing leadership to service delivery teams within the given area.Engage and influence internal and external key stakeholders to drive the strategy, development and continuous improvement within the given area.Ensure customer requirements are understood, critically evaluated, prioritised and addressed within the given area. Work with GCS Leadership and Development Operations Leadership to prioritise the needs and resources needed to deliver these requirements, and supply feedback and clear rationale for any areas that will not be addressed.Member of Operational Governance Teams relating to the given areaResponsible for monitoring performance of the assign system. Define, track and monitor key performance indicators and use these data to inform choice of process and system improvements and input to cross-functional improvements, working in collaboration with GCS LeadershipSupport audit and regulatory inspection planning, preparation and conduct. Responsible for the delivery of Corrective and Preventive Actions to time and quality, and for acting on data or trends identified through the Quality & Risk Management process. Escalate risks and issues to GCS Leadership as needed.Actively look for and promote creative and innovative ideas to drive performance and bring innovative solutions to customers.
2) Customer Service and Support:As the primary point of contact for Development Operations GCS processes, technology and services within a Study Team:Understands the processes, technology and services the study team relies on, their needs and pain points. Uses this knowledge to supply advice and guidance, removes barriers, supplies solutions and finds opportunities for improvement.Ensures the effective resolution of process, technology and service risks and issues that impede the Study Teams progress and effective delivery. Identifies and engages with the right process, technology and service experts, and expertly utilises escalation routes and governance bodies to gain traction and deliver rapid solutionsShares lessons learned and best practice recommendations with the Study Team and with GCS personnel to drive continuous improvement.3) Computer System Validation Oversight:Supplies guidance and expertise in the planning and delivery of system validation activities (core system and study specific validation), including production and archiving of all computer system validation documentation.EssentialBachelor of Science (BSc) in a suitable discipline or equivalent experienceExtensive experience in Drug Development within a pharmaceutical or clinical backgroundHigh-level of business process, technology and Clinical Study information knowledgeExtensive experience in Validation of computerised systems in a regulated environment, preferably the Pharmaceutical industry, including familiarity with documentation such as Validation Plans, Reports, Test scripts etc. and knowledge of regulatory (GxP, SOX (Sarbanes Oxley) etc.) requirements for computerised systems and infrastructureDemonstrated project management skills and proven skills to deliver to time, cost and qualityAbility to work collaboratively, motivate and empower others to carry out individual, team and organizational objectives.Experience in working successfully and collaboratively with external partners (vendors) delivering mutual benefitDemonstrated excellent written and verbal communication and influencing skills, negotiation, collaboration, problem solving, presentation, knowledge transfer (mentoring), conflict management and interpersonal skills.Documentation skills (CRs, plans, reports etc.) in a GxP context.DesirableExpert reputation within the business and industryExperience of using standard process improvement methodologies (e.g. Lean Six Sigma) to find root causes of process issues and find areas of process improvement.Comprehensive knowledge of ICH/GCPRecognised AGILE certification (e.g. SAFe)PowerBI reports/dashboards certification and experienceExtensive experience of Quality Systems and Quality Management, including process definition and process improvement, ideally within an Information Systems environmentProject Management certificationService Management experience. Incident, Problem, Change and Release Management (ITIL)Experience in the development and management of Business Process to deliver business performanceExperience as a test leader for software development of GxP regulated systems.Date Posted25-kwi-2024
Closing Date15-maj-2024
-
Clinical Research Associate
3 weeks ago
Bengaluru, India MS CLINICAL RESEARCH Full timeJob Title: Clinical Research Associate (CRA)Company: MS Clinical Research Pvt LtdAbout Us:MS Clinical Research (MSCR) is a leading clinical research organization dedicated to advancing scientific discovery and improving healthcare outcomes. We are committed to conducting high-quality clinical trials and contributing to the development of innovative medical...
-
Clinical Research Associate
3 weeks ago
Bengaluru, India MS CLINICAL RESEARCH Full timeJob Title : Clinical Research Associate (CRA) Company : MS Clinical Research Pvt Ltd About Us : MS Clinical Research (MSCR) is a leading clinical research organization dedicated to advancing scientific discovery and improving healthcare outcomes. We are committed to conducting high-quality clinical trials and contributing to the development of innovative...
-
Clinical Research Associate
3 weeks ago
Bengaluru, India MS CLINICAL RESEARCH Full timeJob Title: Clinical Research Associate (CRA)Company: MS Clinical Research Pvt LtdAbout Us:MS Clinical Research (MSCR) is a leading clinical research organization dedicated to advancing scientific discovery and improving healthcare outcomes. We are committed to conducting high-quality clinical trials and contributing to the development of innovative medical...
-
Functional Process Owner, Medical Imaging and
4 weeks ago
Bengaluru, India AstraZeneca Full timeGlobal Clinical Solutions (GCS) drives the delivery of Technology and associated processes for the BioPharmaceuticals R&D organisation, owning and providing industry leading technology and services on behalf of Clinical Operations and its internal and external Partnerships. The **Medical Imaging** and **Clinical Standards** **Functional Process Owner (FPO)...
-
Clinical Data Manager
6 days ago
Bengaluru, India George Clinical Full timeWe are expanding! We have many new ground-breaking global clinical trial projects in various phases and therapeutic areas across the globe and want your ideas and expertise to help us build and grow.Who are we?A leading global clinical research organization founded in Asia-Pacific driven by scientific expertise and operational excellence20+ years of...
-
Clinical Data Manager
6 days ago
Bengaluru, India George Clinical Full timeWe are expanding! We have many new ground-breaking global clinical trial projects in various phases and therapeutic areas across the globe and want your ideas and expertise to help us build and grow.Who are we?A leading global clinical research organization founded in Asia-Pacific driven by scientific expertise and operational excellence20+ years of...
-
Senior Medical Writer
4 weeks ago
Bengaluru, India George Clinical Full timeWe are expanding! We have many new ground-breaking global clinical trial projects in various phases and therapeutic areas across the globe and want your ideas and expertise to help us build and grow.Who are we?A leading global clinical research organization founded in Asia-Pacific driven by scientific expertise and operational excellence20+ years of...
-
Associate Clinical Supply Services
1 month ago
Bengaluru, India Merck KGaA Darmstadt Germany Full timeWork Your Magic with us! Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of...
-
Product Owner
2 weeks ago
Bengaluru, India System Soft Technologies Full timeSystem Soft Technologies is a leading technology company that provides innovative technology solutions and consulting services to enhance innovation, business value, and competitiveness. For over 20 years, our focus on becoming a trusted partner to each client has allowed us to become a $140MM+ company with a pool of over 800 associates who cover the full...
-
Associate Product Owner
4 weeks ago
Bengaluru, India Siemens Healthineers Full time**Role**: Associate Product Owner-eMobility** Siemens founded the new business unit Siemens Advanta (formerly known as Siemens IoT Services) on April 1, 2019 with its headquarter in Munich, Germany. It has been crafted to unlock the digital future of its clients by offering end-to-end support on their outstanding digitalization journey. Siemens Advanta is a...
-
Product Owner
3 weeks ago
Bengaluru, India System Soft Technologies Full timeSystem Soft Technologies is a leading technology company that provides innovative technology solutions and consulting services to enhance innovation, business value, and competitiveness. For over 20 years, our focus on becoming a trusted partner to each client has allowed us to become a $140MM+ company with a pool of over 800 associates who cover the full...
-
Product Owner
3 weeks ago
Bengaluru, India System Soft Technologies Full timeSystem Soft Technologies is a leading technology company that provides innovative technology solutions and consulting services to enhance innovation, business value, and competitiveness. For over 20 years, our focus on becoming a trusted partner to each client has allowed us to become a $140MM+ company with a pool of over 800 associates who cover the full...
-
Senior Medical Writer
1 month ago
Bengaluru, India George Clinical Full timeWe are expanding! We have many new ground-breaking global clinical trial projects in various phases and therapeutic areas across the globe and want your ideas and expertise to help us build and grow. Who are we? A leading global clinical research organization founded in Asia-Pacific driven by scientific expertise and operational excellence 20+ years of...
-
Associate Clinical Data Programmer
1 month ago
Bengaluru, Karnataka, India Novo Nordisk Full timeAssociate Clinical Data Programmer **Category**:Data & AI**Location**:Bangalore, Karnataka, IN**Department**:Data Systems & Automation, Bangalore Global Development- **About the department** - Data Systems & Automation, Bangalore Global Development GBS is one of the most competent and diverse team of professionals who are mainly responsible for providing...
-
Associate Product Owner
4 weeks ago
Bengaluru, India Siemens Mobility Full timeRole: Associate Product Owner-eMobility Siemens founded the new business unit Siemens Advanta (formerly known as Siemens IoT Services) on April 1, 2019 with its headquarter in Munich, Germany. It has been crafted to unlock the digital future of its clients by offering end-to-end support on their outstanding digitalization journey. Siemens Advanta is a...
-
Associate Director
1 month ago
Bengaluru, India Baxter Full timeVantive: A New Company Built On Our Legacy Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney...
-
Associate Manager
1 month ago
Bengaluru, India Elanco Full timeAt Elanco (NYSE: ELAN) – it all starts with animals!As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose –...
-
Associate- Clinical Operations
11 hours ago
Bengaluru, India Pococare Full timeCompany DescriptionPococare is a technology-driven healthcare organization focused on redefining medical emergency response in India. Our mission is to reduce the time to get medical attention & ensure swift medical attention is provided within "Golden Hours". Our mission is to reduce the number of people in India who do not receive medical attention on time...
-
Associate Global Scientific Advisor
1 month ago
Bengaluru, India Novo Nordisk Full time**Department**: Global Medical Affairs. **The position** The Associate Global Scientific Advisor (AGSA) is expected to be able to work independently according to Novo Nordisk Standard Operating Procedures and Global Medical Affairs strategy. The Associate GSA strives to be the specialist on the product/project within his/her responsibility. The Associate...
-
Bengaluru, India Viatris Full timePosition Title : Executive / Assistant Manager - Clinical Operations (Clinical Research Associate)Location : BangaloreAt VIATRIS™, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.Viatris empowers people worldwide to live healthier at...