Study Document Coordinator

1 day ago

Sheffield, United Kingdom Allergy Therapeutics Full time

About Us

Allergy Therapeutics are a market leading, pioneering immunology business with specialist experience in the research and development of allergy treatments.


We believe that transformational outcomes for patients are achieved by directly treating the cause, rather than just managing symptoms. Our vaccines are aluminium free. Driving convenience; our ultra-short course treatments make life easier and increase adherence.


Our adjuvant technologies not only advance the results of allergy immunotherapy but also drive beneficial immune responses in cancer and infectious disease.


We are a proud and passionate team with a vision that delivers growth and transforms the way we think about immunology.


We are continuing to grow and it’s an exciting time to be joining us. You will contribute to our ongoing success and be part of our future which is looking very bright


You’ll join a team of like-minded people who are passionate about what they do and providing positive outcomes for our patients.


We are looking for a Study Document Coordinator who will provide the mentorship, subject matter expertise, vendor oversight and clinical study team support required to ensure that the electronic Trial Master File (eTMF) for all assigned studies is managed in accordance with relevant ICH guidelines, GCP regulatory requirements and other regulations, as appropriate. This will involve leading/assisting with the management and enhancement of any Standard Operating Procedures (SOPs), work instructions and QC practices relevant to the management of the eTMF, as well as oversight for, and hands-on management of, the eTMF contents, as required.


About you

We are looking for someone with thorough knowledge of clinical Trial Master File (TMF) process and activities and an excellent working knowledge of clinical documentation and reporting. You will also have experience in clinical development/clinical operations, including experience with document management systems and excellent understanding of system structures and generic document management functionality.


You will have knowledge of research and regulatory environments i.e., International Conference on Harmonization (ICH), Good Clinical Practice (GCP).


This role involves interaction with key stakeholders, both internally and externally so you must be a confident communicator who is able to manage deadlines and push activities/actions through to completion.


The role


You will be involved in the following:


eTMF Related Responsibilities:

  • Act as Subject Matter Expert and primary point of accountability for the company’s Trial Master File processes
  • Oversee general TMF operations and filing activities; mentor study teams and deliver training to ensure high quality eTMFs
  • Ensure completeness, quality, and accuracy of Trial Master Files for clinical trials and ensure inspection readiness according to local procedures
  • Lead/ assist in the development and update of standard operating procedures (SOPs) and corresponding controlled documents that are in line with relevant regulatory regulations (e.g., ICH-GCP, and regulatory requirements such as FDA, EMA and MHRA) and industry best practices (e.g., TMF Reference Model)
  • Enhance/ redefine, review, and/or approval of study specific TMF procedural documents and TMF management plans and TMF Indexes in collaboration with internal and external (third party vendor) study team members
  • Lead inspection readiness & Completeness checks/quality reviews of TMF documents and across sections of the TMF (e.g., trial, country, site) and work with internal and external team members to ensure that any findings are resolved satisfactorily and within a timely manner
  • Enhance/ redefine, implement, and provide standard TMF metrics/KPIs to demonstrate document quality, TMF completeness, and process compliance
  • Coordinate the transfer of any study specific TMFs/eTMF from third party vendors as required by the TMF Plan


GCP quality related Responsibilities:

  • Cooperate closely with the GCP Director (QA) to ensure compliance with regulations, guidelines and company SOPs within the Global R&D – Clinical Department
  • Lead Clinical SOP Management within the eQMS, coordinating review and approval of internal clinical SOPs
  • Review of Global R&D – Clinical procedures to ensure compliance with QA policies, GCP and relevant regulatory requirements within the clinical department
  • Coordinate training for the clinical department as needed including GCP Training


This is a remote role.

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