Business Applications Manager - GMA Oncology
Daiichi Sankyo, Inc.

Job Description

Join a Legacy of Innovation 110 Years and Counting!

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

Join a Legacy of Innovation 110 Years and Counting!

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

Job Summary:

The Business Application Manager will have overall responsibility of managing and maintaining Medical Affairs Clinical Operations technology platform(s) and associated business level administration activities. This role will be responsible to develop a consistent setup and maintenance of business-related system level tasks based on approved requirements, processes, and program needs and centrally facilitate governance over prioritization and management of application changes to the Medical Affairs (MA) Accelerate platform in close collaboration with Clinical Operations business teams and Global IT service management team.

Responsibilities:

System:

• Act as a central global business system manager and system power/super user for the Medical Affairs owned Clinical Operations application (MA Accelerate) for management of Medical Affairs Studies (Investigator Initiated Studies, Collaborative Research, Company Sponsored Medical Affairs studies and Expanded Access Programs).
• In collaboration with IT Global Service Manager, Responsible for user and permissions management, including profiles, permission sets, roles, owners, role hierarchy, etc.
• Maintain list of configuration elements such as value drop down menus or notifications within the system and ensure terminology is consistent with business expectations
• Maintains all system master configuration files, training materials and monitor support email groups working closely with respective leads from Clinical Operations team.
• Track the types of requests/questions raised by external requestors as received from business teams and work closely with internal coordinators (Global and Region) for any business side support questions (questions about their application, DS process, etc.) to provide a unified response.
• Participate in any champion forums led by Clinical Operations leads around technology enhancements and facilitate prioritization through champion network.

Business Process:

• Under the guidance of ESR Lead (Externally sponsored research), CSS (Company Sponsored Studies) Lead an EAP (Expanded Access Program) lead, assists in the development of operational process specifically around use of the Clinical Operations Accelerate system.
• Communicates and actively collaborates with managers and leaders concerning the operational business process and helping to achieve organizational goals and objectives.
• Lead IT change management activities related to the application(s) including but not limited to change requirements, assess business impact on changes to the application, and working closely with IT/Vendor teams in module implementations.
• Provide oversight of all associated technology project documentations, configurations and trainings in collaboration with business leads of the department and the IT Global service manager.
• Assess impact of application changes on the business/users and provide input to business leads
• Assists with development of business requirements around Med Affairs technology solutions and User Acceptance Testing (UAT) of the system.
• Act as business approver, as part of the IT Change Management process, for application changes/releases working closely with business leaders and user account management per IT service management process
• Address business/process how-to questions in collaboration with IT

Training:

• Provide informal training of the system, as required, for user groups
• Prepare and update training materials for the application, as required/ Work closely with a vendor for building training materials.
• Work with business and regional leads to plan and execute, ongoing training requests

Audit:

• Track types of questions related to process and application, and provide leadership with recommendations for any additional training needs
• Assist in department level initiatives/ operational excellence activities, as required, and supports software audit processes in collaboration with Information Technology teams.
• Acts as liaison to Quality Assurance and Compliance in partnership with Clinical Operations Leads.
• Ensures that application documentation is consistent with the best practices, applicable SOPs/Operational procedures as appropriate.

Reports:

• Assist business leads with generating reports to continuously monitor data quality and integrity.
• Run metrics/reports from the system, and provide business leadership updates, as requested

Vendor/IT Relations:

• Acts as a Liaison between MA Clinical Operations teams and Information Technology teams to address Internal and External stakeholders' questions around MA Accelerate platform.
• Escalate any configuration and/or application submission issues to Information Technology team/vendor (EnVision) as needed
• Develop and provide periodic reviews and recommendations in collaboration with business owners, target list of enhancements to business applications for consideration, to be included to their technical roadmap

Qualifications:Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:

• Bachelor's degree in relevant discipline like Lifesciences/Healthcare (or equivalent years' experience) required. Master's degree in Clinical/Business Administration preferred.
• 4+ years of experience in the pharmaceutical industry
• Business System Manager/Administration experience around Clinical systems in Pharma industry.
• Working knowledge of clinical development process, clinical operations experience and GCP.
• Experience in defining and implementing Clinical (IIS, Expanded Access Programs and Medical Affairs Sponsored studies) technology solutions is preferred
• Experience with IT change management processes. Familiar with Training Delivery.
• Ability to manage and collaborate with multiple stakeholder groups both internal and external and influence and incorporate multi requirements, and points of view to achieve business objectives and goals
• Ability to plan, manage, and execute activities and tasks and drive towards completion with excellent time and project management skills.
• Independently motivated, detail oriented and demonstrated problem-solving ability.
• Excellent documentation, organization, presentation and training skills.. Ability to work independently and within teams, and multi-task in an extremely fast-paced environment with multiple changing priorities.
• Excellent communication skills and ability to influence across multiple business and IT functions.
• Advanced proficiency in Microsoft products.

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

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