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Manager Trial Master File Operations

Location
Basking Ridge, New Jersey
Job Type
Permanent
Posted
13 Jun 2022

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

Manager TMF Operations is responsible for ensuring completeness, quality and accuracy of assigned Trial Master Files for Daiichi Sankyo's clinical trials and ensures they are "inspection ready". Establishes relevant procedures and processes, and performs quality control review for study documents, as well as aggregated risk based reviews of priority TMFs for inspection readiness. Oversees and assigns for processing incoming of clinical study documents from clinical research organizations (CROs) and Daiichi Sankyo functional areas (e.g. Clinical Operations, Data Management), including paper records. Represents TMF Operations in internal and external meetings involving management of clinical study TMFs. Interfaces with CROs, clinical operations, QA, regulatory affairs and other groups throughout Daiichi Sankyo to resolve TMF issues. Ensures management of study TMFs are in compliance with Daiichi Sankyo's SOPs and polices. If necessary, substitutes for the Associate Director at TMF related meetings.

Responsibilities

    • Manage and supervise assigned operational aspects of the TMF Operations function; prioritizing workload of DS internal and contractor staff. This includes but is not limited to:
      o Performing quality control checks on documents generated by all functional groups within DS and external partners who submit TMF documents into Veeva eTMF Vault and place in the QC workflow.
      o Effectively communicating internal compliance metrics with managers and other colleagues within clinical and regulatory operations as well as Daiichi Sankyo affiliates and CRO(s) performing Trial Master File tasks on behalf of Daiichi Sankyo, to improve and maintain data quality for DS studies.
      o Manages TMF Operations contractors and provides vendor oversight to ensure compliance with established TMF management procedures and policies.
  • Performing quality control checks on documents generated by all functional groups within DS and external partners who submit TMF documents into Veeva eTMF Vault and place in the QC workflow by producing metrics to be shared with management.
  • Provides leadership and work guidance to both internal DS personnel and contractors, remotely located contractors, and CRO/vendor staff to answer questions, triage problems and requests regarding system support issues with Veeva eTMF Vault support vendors.
  • Responsible for assigned TMF process improvement initiatives and implementing new processes utilizing key technologies. Oversees and provides assistance in the evaluation of processes to ensure organizational responsibilities are met.
  • Supports design and configuration changes of the DS Veeva eTMF Vault system. Contributes as an ad hoc member of the Veeva eTMF Vault change control board. Participate in the Veeva eTMF Vault Users Group across DS regions.
  • For each new clinical trial work directly or oversee the work with functional groups to ensure associated TMF management processes are in alignment with established DS processes.

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, business, or related field preferred or equivalent combination of education and experience. preferred
Experience Qualifications
  • 7 or More Years experience in information or document management in an end user computing environment. preferred
  • Experience working with records management and archival procedures. preferred
  • Experience working with validated system implementations and Pharma/Health Care organizational processes preferred
  • Detailed knowledge of Regulatory/Clinical documents. preferred
  • 4 or More Years experience working with clinical trial documentation. preferred
  • Experience working in an eTMF system 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.

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.

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Details

  • Job Reference: 623857626-2
  • Date Posted: 13 June 2022
  • Recruiter: Daiichi Sankyo
  • Location: Basking Ridge, New Jersey
  • Salary: On Application
  • Sector: Healthcare & Medical
  • Job Type: Permanent