Manager, Data Management in Basking Ridge, NJ at DSI

Date Posted: 3/10/2020

Job Snapshot

Job Description

Join a Legacy of Innovation 110 Years and Counting!

With over 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 hypertension and thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with a Competitive Advantage in Oncology,” Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases.

Job Summary:
Position manages end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs and other vendors to ensure high quality deliverables are on time and within budget to support drug development processes and global submissions. This position also partners with internal and external stakeholders to optimize Data Management technology, processes, and standards.

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:
  • Establishes Data Management strategy at the project and/or study level for a smaller number of projects/studies Proactively identifies and manages risks at the project and/or study level for a smaller number of projects/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.

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.

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/Experience:
MS/BS/RN in life sciences or related field (or equivalent experience)
5+ years data management and/or related industry work experience in a medical device, pharmaceutical company, or similar environment (e.g., CRO)

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.