Manager, Data Management - CDx

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. 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 manages end-to-end delivery of Data Management services for assigned Projects/Studies (Clinical and / or Companion Diagnostics), collaborating with DS CRO Partners, DS Internal Stakeholders as well as DS External Stakeholders to ensure high quality deliverables are on time and within budget to support drug development processes and global submissions.

This position has a working knowledge of Electronic Data Capture/related applications and industry standards, and moderate technical skills in working with data received from CROs and other third-party vendors. This position has strong verbal/written skills, analytical, organizational, and interpersonal skills and is able to work effectively with people at different levels and from different disciplines and cultures. Additionally, this position possesses a working 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 within one or more therapeutic areas. Finally, this position has moderate skills in continuous improvement, project management, change management, and risk management.

Responsibilities

• Leadership, Direction, and Strategy:
  • Lead and establishes Data Management strategy at the Project and/or Study level (Clinical and / or Companion Diagnostics)for assigned Projects/Studies and proactively identifies and manages risks at the project and/or study level by collaborating with Internal Stakeholders, External Stakeholders as well as CRO Partners.
  • Oversees operational scope of Oncology & Companion Diagnostics studies and plans to achieve milestones on-time. Identifies barriers to timely and successful data transfers and proposes solutions to same.
  • Maintains knowledge of current regulations and technologies related to the data management function. Demonstrates project management skills including the ability to manage Data Management aspects for Outsourced studies.

• Project Management:
  • Plans and directs the conduct of Data Management activities for assigned projects/studies through outsourcing (e.g., study startup, study conduct, study closeout, and reporting).
  • Provides oversight for Data Management CRO and other third-party vendors to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory guidelines, Policies, SOPs, and other relevant guidelines.
  • Ensures Data Management deliverables meet/exceed project/study team expectations regarding quality, time, and cost and that Data Management documentation is filed/archived according to applicable Daiichi Sankyo and regulatory requirements.
  • Work Cross-functionally with Internal DS Stakeholders especially Precision Medicine (such as Translational Medicine, Clinical Biomarkers, Biosample Operations, etc.) to ensure on-time and compliant data management support for Oncology & Companion Diagnostics studies.
  • Accountable for all data management aspects of Companion Diagnostics development with external partners to develop, validate and implement diagnostic tests required for specific Oncology studies.

• Functional Expertise:
  • Reviews/approves clinical study related documents (e.g., Protocols, Data Management Plan, Clinical Study Reports).
  • Leads and drives the data review process in collaboration with the study team to ensure data quality
  • Participates in audits and inspections.
  • Ensure clinical study data are collected, handled, and validated in an appropriate and consistent manner to ensure a high-quality database is delivered for statistical analysis within the agreed upon project timelines by CRO Partners.
  • Lead end-to-end data management strategy within early and late-stage Oncology studies to align all diagnostic development milestones with clinical development milestones and biomarker strategy.

• Operational Efficiency / Continuous Improvement:
  • Provides comprehensive data management expertise to project/study teams to optimize study-specific clinical trial processes.
  • May participate in process improvement initiatives.

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)

• Master's Degree in life sciences or related field (or equivalent experience) preferred
• Bachelor's Degree in life sciences or related field (or equivalent experience) preferred
• RN in life sciences or related field (or equivalent experience) preferred

Experience Qualifications

• 4 or More Years data management and/or related industry work experience in a medical device, pharmaceutical company, or similar environment (e.g., CRO) preferred.
• 2 or More Years of Companion Diagnostics / Medical Device industry work experience in medical device, pharmaceutical company, or similar environment preferred.
• Drives for results - demonstrates interest and ability to learn new things, takes initiative, welcomes problems as challenges, finds solutions to technical problems.

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.