Manager Clinical Systems

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. 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. SummaryThis role has the flexibility to function on a remote basis for those outside the region OR corporate Basking Ridge NJ site based.

Manager, Clinical Systems is responsible for partnering with business stakeholders and decision makers to enhance the capabilities and utilization of the electronic trial master file (eTMF) system, the Clinical Trial Management System (CTMS) and other clinical operations related systems, including support for the collection business requirements/enhancements, release planning and execution, build and deployment of reports, risk and issue mgmt and the stewardship of data housed within the systems.  The position requires a solid understanding of business processes and roles with the ability to translate needs into enhancements to support strategic business decisions.  Represents Clinical Systems in internal and external meetings involving management of clinical operations systems.  Interfaces with CROs, Clinical operations, IT and other functional groups throughout Daiichi Sankyo to optimize system delivery and resolve known issues.  Ensures management of clinical systems are in compliance with Daiichi Sankyo's SOPs and polices.

Responsibilities

• • Manage operational aspects of Clinical Systems. This includes but is not limited to:
    o Creating templates for the effective running of UAT, checklists for data migration/exports, testing of data migration/exports, and other related tasks. Work with the business owner of Clinical Systems to ensure enhancements are being applied per business road map for system.
    o Manage contractor resources as required.
    o Provide vendor oversight to ensure business needs are being met.
• Manages end to end the User Acceptance Testing for enhancements to Clinical Systems, including identification, planning, sandbox testing, running UAT and communicating results to senior management, as well as end users.
• Identifies, develops, and executes the development of business process improvement opportunities and also identifying new Clinical Systems for the organization.
• Establishes and maintains effective and timely communication across the DS organization. Works with others in Clinical Systems in a backup role, in order to represent Clinical Systems needs as appropriate.

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university)

• Bachelor's Degree in life sciences, business, or related field preferred or equivalent combination of education and experience. preferred

Experience Qualifications

• 7 or More Years experience in information management in an end user computing environment. preferred
• Experience working in Clinical Systems (eTMF, CTMS, etc.) preferred
• Experience working with validated system implementations and within Pharma/Health Care organizational processes preferred

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.