Director, Data Management

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.

Summary

Position provides leadership within Data Management by partnering with internal and external stakeholders to optimize Data Management technology, processes, and standards. This position manages Data Management staff and/or leads multidisciplinary and/or regional teams to achieve departmental objectives. Additionally, this position develops/proposes strategies within Data Management and collaborates cross-functionally to ensure successful outcomes for projects/studies.

This position also has significant knowledge of Electronic Data Capture/related applications and industry standards, and significant skills in working with data received from CROs and other third party vendors. This position has solid verbal/written skills, analytical, organizational, and interpersonal skills and works effectively with people at different levels and from different disciplines and cultures. This position leverages interpersonal skills and extensive clinical trials experience to mentor/coach within Data Management and cross-functionally. Additionally, this position possesses advanced knowledge of clinical operations and relevant regulatory requirements. This position has experience working on Phase I-IV studies within the medical device and/or pharmaceutical industry across multiple therapeutic areas and actively participates in regulatory submissions and inspections. Finally, this position has significant skills in continuous improvement, project management, change management, and risk management.

Responsibilities

• Leadership, Direction, and Strategy:
  • Manages Data Management staff and/or leads projects/studies and/or initiatives to exceed/achieve departmental quality/time/cost objectives.
  • Leads development of Data Management strategy and solutions at the project and/or study level.
  • Plan and develop staffing allocations including assessment of candidates, recommend hiring
  • Manage the clinical data managers, mentor staff, assess performance
  • Responsible for all Data Management timelines and deliverables from study start up to final clinical study report
  • Provides vendor oversight to ensure that the process, procedures, data deliveries, timelines and study documentation created are of high quality, compliant with the study requirements, SOPs and GCPs.
  • May lead/support Data Management activities at the project and/or study level.
  • Proactively identifies and manages risks at the functional level and/or for assigned project/studies and/or initiatives.
  • Ensure timely and quality delivery of the data ensuring quality data for DSMB, DSUR, interim analysis, database lock, TLFs, final clinical study report (CSR)
  • Participate in cross functional team meetings as requested
• Project Management:
  • May plan/direct the conduct of Data Management activities for assigned projects/studies through outsourcing.
  • May plan/direct the activities of multidisciplinary teams working on regional initiatives.
  • Resolves and/or escalates issues encountered at the project/study, and/or functional team level.
• Functional Expertise:
  • Acts as coach/mentor within Data Management and for Project/Study teams.
• Operational Efficiency / Continuous Improvement:
  • Provides leadership within Data Management by partnering with internal and external stakeholders to optimize Data Management technology, processes, and standards (improving quality/inspection readiness, decreasing cycle times, and reducing costs).
  • Leverages comprehensive Data Management expertise to promote best practices regionally across the Clinical Trial lifecycle.
  • Maintains awareness of Data Management emerging trends, technology and best practices and makes recommendations for regional improvements.
  • Develops and maintains peer relationships with thought leaders in Data Management and related areas.

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 or related field preferred
• Master's Degree in life sciences or related field preferred

Experience Qualifications

• 10 or More Years data management and/or related work experience in a medical device or pharmaceutical company, or similar environment (e.g., CRO) preferred
• 4 or More Years combined experience managing people and/or initiatives 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.