Senior Specialist, TMF Operations in Basking Ridge, NJ at DSI

Date Posted: 2/3/2021

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:

Participates in electronic QC and indexing of TMF documents as required. Utilizes TMF tools and technology to accomplish tasks without supervision. Proficient in TMF management and can train others. Leads the compilation of the TMF Management Plan and TMF Index in association with the TMF Owner and CROs. Leads the development of TMF technology and tools to accomplish tasks. Regularly trains others on TMF process and provides input on overall training strategy. Participate in policy/procedure development and drafting. Manage Help Desk queries through to resolution within appropriate timeframes. Serve as TMF SME to study teams and functions.

Ensure that the clinical trial documentation is consistent with the Trial Master File specifications, applicable SOPs, ICH/GCP guidelines and other regulatory agencies requirements. Ensure the Trial Master Files are inspection ready. Ensure Trial Master File study specifications are in alignment with program strategy and milestones. Develop consistent setup and maintenance of Trial Master File requirements, processes and program. Ensure that documentation flow for Trial Master File documents meet the required timelines and intervene with action plans and follow up as appropriate. Act as the point of contact for audits/inspections related to the Trial Master File processes and activities and assist with the development of corrective action plans related to Trial Master File findings. Review data quality outputs and audit outputs to identify trends per study and across programs. Develop metrics for performance tracking and document trends for improvement processes of Trial Master File reviews.

Manage study setup in the eTMF System on a timely basis for studies assigned and communicate same to end users.


Executes multiple, highly complex TMF related applications simultaneously in a matrix environment.

Oversees and provides assistance in the evaluation of processes to ensure organizational responsibilities are met.

Identifies, executes, and assists in the development of business process improvement opportunities.

Establishes and maintains effective timely communication across Clinical Operations. Works with and represents CO’s needs as appropriate.

Communicates and actively collaborates with managers and leaders concerning the TMF process and communicates organizational goals and objectives

Attends and participates in TMF meetings to develop increased knowledge and application of TMF tools

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.


Bachelor’s degree in relevant discipline (or equivalent years' experience)

4+ years of experience in the pharmaceutical industry
Clinical Operations and TMF related technical skills

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.