Manager, Data Management – Lab Specialist in Basking Ridge, NJ at DSI

Date Posted: 4/15/2021

Job Snapshot

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.

Job Summary:
The position manages the end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs and other vendors to ensure high quality deliverables on time and within budget to support drug development processes and global submissions. This position provides leadership within Data Management by partnering with internal and external stakeholders to deliver clinical trials timeline focused on Oncology. Additionally, this position will contribute to the Data Management process improvements, technology assessments, and standards.
  • Serve as the subject matter expert and take leadership role in managing the process of external lab data, such as standardizing and harmonizing the procedures including but not limited to central lab, bioanalytical data, ECG, central read or other non-CRF data. Specifically, take leadership in electronic data acquisition, standard data structures and procedures to support downstream analysis. Will serve in the leadership role in the interaction with the cross-functional teams to ensure optimal external data processes.
  • Serve in the leadership role in managing local lab processes, including review and approval of new analytes, naming conventions or synonyms, new units, conversion factor, or templates. Will interact directly with internal stakeholders as well as Japan and European teams to ensure related harmonization.
Responsibilities:
  1. Serve as the subject matter expert in the local laboratory parameters: Analytes, Synonyms, Units, Conversion Factors, Laboratory Names, related templates and other standard elements. Review and approve new requests from studies for the local lab parameters mentioned above. Reach out to the pertinent departments for consultation when needed.
  2. Interact with Japan and/or other regional lab experts in harmonization of standard local lab parameters. Take leadership in the SOP/SOI concerning external data management, including standard data structure, transfer and reconciliation. Take leadership in the standard templates including standard EFTS. Serve as the subject matter expert in the standard lab data structures, Naming Conventions, Codelists concerning the laboratory/electronic data.
  3. Serve as the subject matter expert for consultation in lab data set up during study protocol review, oversight on study lab setup, UAT or study templates. Serve as the subject matter expert in support of study level EFTS and reconciliation spec/process.
  4. Support lab related CRF design from both global and study perspectives.
  5. Participate in the global or cross-functional initiatives related to lab data. Update Management of progress made in lab related initiatives or related risks. Perform other tasks as requested by management.
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:
  1. Bachelor's Degree/Master’s Degree or RN in life sciences or related field preferred. Training in Clinical or Life Science preferred.
  2. Minimum overall experience of 4 years with clinical data management systems and clinical trials experience.
  3. Medical or laboratory background with understanding of laboratory tests, safety ranges, procedures and conversion factors, as well as associated regulations and industry standards.
  4. Knowledge of Medidata RAVE clinical database system and Lab Admin module preferred.
  5. Excellent interpersonal, verbal and written communication skills.
  6. Superior Project Management skills.
  7. Ability to work independently and exercise critical thinking and judgment.
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.