Trial Master File Document Coordinator

.Transformative methods. Inquisitive minds. Life-changing foresight.
** Trial Master File Document Coordinator**£30,000 - £34,000 plus
*
* Reports to:

** Clinical Operations Manager  
** Directorate:
** Research & Innovation   
*
* Contract:

** 2 year fixed-term contract   
*
* Hours:

** Full time 35 hours per week (Flexible working requests considered)   
*
* Location:

** Stratford, London Office-based with high flexibility (1-2 days per week in the office)  
** Closing date:
** 23:55pm Sunday 25 January 2026
** Visa sponsorship:
** You must be eligible to work in the UK to apply for this vacancy. Cancer Research UK is
** not
* * able to offer visa sponsorship.
** Recruitment process:
** Competency based interview, followed by second stage on-site interview with a task.  
** Interview date:
** W/C 2nd February
** At Cancer Research UK, we exist to beat cancer.
** Cancer Research UK are looking for a Trial Master File Document Coordinator to join our Centre for Drug Developments Clinical Study Coordinator team, reporting into the Clinical Operations Manager.

The Cancer Research UK Centre for Drug Development (CDD) is the world's only charity-funded drug development facility. Our pioneering research is driven purely by the goal to see scientific breakthroughs bring benefits to patients sooner. CDD is the sponsor of early phase and precision medicine clinical trials in oncology agents. Our broad portfolio rivals that of a medium-sized pharmaceutical company, spanning antibodies, cell therapies, vaccines, drug conjugates and small molecules, making this an interesting and dynamic area to work in.

This is a two year contract specifically to work on our  trial, our multi-drug, precision medicine platform trial for adults and children. It’s one of the UKs leading early phase oncology trials, and the first UK national precision medicine trial in rare  this role you will use your experience of Trial Master File Document Management to aid in the development of new cancer therapies by leading Trial Master File (TMF) activities for CDD Studies in accordance with Cancer Research UK Standard Operating Procedures (SOPs) and policies, ICH GCP guidelines, UK legislations and other regulatory requirements.

You could currently be working  in a TMF role within a clinical trial environment looking to develop Trial Master File knowledge within a cause driven environment that has direct impact on patient benefit. Or you could be a Trial Coordinator or Clinical Trail Assistant looking for that next step to move into a TMF role.

Whatever your background you’ll preferably need to bring previous experience of Trial Master File Document Management including a strong knowledge of clinical study documents and experience in a supportive role.
* Ensure compliance with Centre for Drug Development (CDD) SOP’s and procedures to assist with maintaining an inspection ready eTMF.
* Ensure completeness of the eTMF through regular eTMF reviews.
* Perform Quality Checks of documents to ensure a high level of document quality.
* Maintain awareness of study events related to documents required for the TMF.
* Filing of study team TMF documents within the required timelines.
* Resolving and assisting with any queries relating to TMF documents and the study.
* Running eTMF metric reports as required and assisting with updates to the study TMF Plan.
* Review of documents received from sites, if required.
* Sending required documents to sites in accordance with CDD procedures, if required.
* Review of localised site documents, if required.
* Managing study level eTMF access and site set up, if required.
* Assisting with study specific TMF audit actions, if required.
* Reconciliation of TMF and Investigator Trial File (ITF) documents, if required.
* Participate as a member of the TMF Champions Group to support eTMF processes across CDD.
* Leading on study specific TMF archiving activities.
* Other TMF activities or support for the project team as required.
* Previous experience of Trial Master File Document Management including a strong knowledge of clinical study records.
* Knowledge of ICH GCP.
* Knowledge of the TMF Reference Model.
* Strong attention to detail.
* Proficient in the…