Trial Master File

2 weeks ago

Cambridge, United States Integrated Resources, Inc ( IRI ) Full time

Client is a global precision therapy company that invents life-changing therapies for people with cancer and hematologic disorders. Applying an approach that is both precise and agile, we create medicines that selectively target genetic drivers, with the goal of staying one step ahead across stages of disease. Since 2011, we have leveraged our research platform, including expertise in molecular targeting and world-class drug design capabilities, to rapidly and reproducibly translate science into a broad pipeline of precision therapies. Today, we are delivering approved medicines directly to patients in the United States and Europe, and we are globally advancing multiple programs for genomically defined cancers, systemic mastocytosis, and cancer immunotherapy.

What will you do?

This position reports into a Sr. Manager or Associate Director of Clinical Operations (or above).

This role maintains TMFs ensuring they are current and inspection-ready for internal and external entities. The right candidate will possess an understanding of clinical trial conduct, TMF structure (DIA Reference Model), eTMF systems, and best documentation practices.

What will be your responsibilities?

  • Responsible for managing clinical document quality/control/filing, and the Trial Master Files (TMFs).
  • Performs set up activities, document filing and oversight of internal e/TMF applications
  • Supports Clinical Operations Study Leaders in the QC and oversight of CROs’ e/TMF applications
  • Functional lead for specified e/TMF platform with vendor(s)
  • Provide support and guidance to CROs and support staff to ensure accurate and timely eTMF filing and maintenance according to ICH GCP guidelines
  • Provide training to eTMF users and external parties (CROs)
  • Partner with management and others to support functional and organizational initiatives, to drive new procedures and ideas, and to function as an advocate for processes and decisions
  • Supports the development and review of standard operating procedures and work instructions related to clinical document management, as appropriate
  • Creates and maintains written instructions, SOPs, guidelines and plans as they relate to e/TMFs and document control
  • Updates and maintains Naming and Filing Guide(s) for relevant e/TMF systems
  • Work in collaboration with all applicable functional areas
  • Work in collaboration with Clinical Operations Management to drive new procedures and processes within the department, as appropriate


What qualifications do we require?

  • Bachelor’s degree or equivalent combination of education/experience in science or health- related field
  • Minimum 5 years of e/TMF experience for a pharmaceutical, biotechnology company, or contract research organization
  • Thorough knowledge of all sections of the DIA Reference Model (current version)
  • Thorough knowledge of documents from various functional areas and their appropriate e/TMF filing requirements
  • Thorough knowledge of International Council for Harmonization (ICH) Good Clinical Practice (GCP) as well as Good Documentation Practice (GDP) principles


What qualifications do we prefer?

  • Experience with eTMF system or software to include but not limited to development of SOPs, user training manual, performing UATs and validations, etc.
  • Thorough knowledge of electronic TMF application(s), for major non-proprietary system(s) and ability to prioritize related tasks based on project goals


What capabilities do you bring?

  • Motivated self-starter who is capable of flourishing in a fast-paced small company environment.
  • Creative problem solver with excellent communication and public speaking skills.
  • Proficiency in developing and delivering educational materials, both written and oral
  • Ability to engage in cross-functional interactions with internal and external staff
  • Global trial experience
  • Strong interpersonal and organizational skills are needed, with a high degree of attention to detail.

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