View Our Website View All Jobs

Manager, Trial Master File (TMF)

Job summary

  • Defines and manages processes associated with the storing, archiving, indexing, scanning, and classifying of study documents and related records regardless of location, format or media type,
  • Prepares and maintains TMF related manuals, training materials, policies and procedures and other related quality documents,
  • Reviews and provides comment on SOPs and other Controlled Documents that impact the TMF
  • Ensures TMFs are inspection-ready at all times,
  • Assists clinical teams in the development of TMF plans and other TMF related activities,
  • Participates in the selection, management, and oversight of vendors hired to perform TMF management activities, if applicable,
  • Trains internal and external vendor staff regarding TMF processes, work flows, metadata, naming conventions, QC checks, etc.
  • Establishes process controls, including the identification of key performance indicators (KPIs) by which processes will be assessed,
  • Uses KPIs to direct efforts to improve processes and intervene as issues are identified,
  • Responds to internal and/or external information inquiries related to the TMF; supports internal and external audits and inspections, including development and implementation of CAPA activities and results,
  • Manages the transition of TMF records for acquisitions and divestitures,
  • Continuously evaluates regulatory requirements for TMF management (active and archival) and assesses impact to company’s established processes; contributes to risk evaluation and mitigation strategies
  • In association with IT and other departments, manages the TMF technology provider(s)
  • Participate externally in TMF related initiatives, conferences, etc. and remain current on trends and changes related to TMFs

Minimum requirements

  • BSc, BN, PharmD or equivalent in scientific/medical/pharmaceutical discipline
  • Extensive knowledge of ICH-GCP guidelines and major Health Authority regulations as they pertain to the operational aspects of clinical studies and the management of TMF content
  • At least 5 years of experience in eTMF management
  • Extensive experience with Veeva Vault
  • Significant understanding of, and experience with, the DIA TMF Reference Model
  • Advanced understanding of clinical research and drug development, and specifically the stages of a clinical trial and the corresponding records required
  • Ability to communicate with internal and external customers and provide a high level of service
  • Strong interpersonal, organizational, analytical, and time management skills
  • Ability to identify opportunities for process and compliance improvements
  • Ability to identify and respond to problems
  • Ability to achieve change and improvement in a matrix environment

Disclaimer

Inovio Pharmaceuticals, Inc. is committed to a policy of equal employment opportunity. In keeping with our policy, Inovio will recruit, hire, train and promote into all job titles the most qualified individuals, without regard to race, color, creed, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.

A current US work authorization is required.  The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Inovio offers an attractive benefits package and is an equal opportunity employer. 

 

 

Read More

Apply for this position

Required*
Apply with Indeed
Attach resume as .pdf, .doc, or .docx (limit 2MB) or Paste resume

Paste your resume here or Attach resume file

To comply with government Equal Employment Opportunity / Affirmative Action reporting regulations, we are requesting (but NOT requiring) that you enter this personal data. This information will not be used in connection with any employment decisions, and will be used solely as permitted by state and federal law. Your voluntary cooperation would be appreciated. Learn more.
Gender
Race
Veteran/Disability status