Job Description

The Trial Master Files Records Specialist (TRS) is responsible to provide operational expertise to the core trial team, oversees the implementation of the TMF strategy for the trial and supports the core trial team in all aspects of TMF management, and in inspections or audits. The TRS provides and maintains oversight and guidance related to TMF activities throughout the course of the trial, to safeguard the protection of the trial subject, reliability of the trial results, compliance with study protocol, ICH-GCP and applicable regulations and ensure inspection readiness at all times.

Electronic Trial Master File (eTMF) Set Up

Collaborates with the core trial team to create, implement and maintain the list of trial-specific expected records Identifies all relevant trial level records required to reconstruct the trial, independent of owner or system hosting the record. Responsible for the planning and tracking of all TMF trial level records according to internal and external standards and also to initiate the close out of the TMF Responsible for the oversight of all outsourced local trial records specialist (LTRS) activity in each participating Operating Unit (OPU) Establish Sponsor File Records Create, finalize, and communicate the trial specific TMF Framework in collaboration with the core trial team Review the draft trial specific list of essential records (LoER) and obtain input from the trial team Finalize and communicate the final trial specific LoER to Clinical Trial (CT) Managers and LTRSs in all participating OPUs

Electronic Trial Master File (eTMF) Maintenance

Maintain Global Trial Master File throughout trial Communicate TMF timeliness, completeness and quality metrics to the CT Leaders and CT Managers through participation in Trial Oversight Meetings (TOM) Maintain close collaboration, communication and support of trial teams to keep them informed with the latest documentation management updates. Oversee TMF status and take appropriate action if the TMF does not fulfill the requirements (timeliness, completeness and quality) Participate in Trial Oversight Meetings and present TMF topics Support of the trial team in all aspects of TMF management and in inspections or audits Supports the Corrective and Preventative Actions (CAPA) Lead in the development of actions and follow up on assigned actions resulting from audits and inspections Update the trial specific TMF Framework if a main trial event is planned/occurs that has an effect on trial records (e.g. Clinical Trial Protocol amendment) and communicate to CT Managers and LTRSs in all participating OPUs May contribute to non-trial projects as assigned

Electronic Trial Master File (eTMF) Close Out

Close out Trial Master File Inform the CT Leader about the list of exceptions on the global trial level regularly and finally when all records are received Create the final global list of trial, country, and site-specific exceptions with input from the LTRS Confirm the archiving pre-requisites have been met with input from trial team and LTRS (Trial Documentation Specialist) before the TMF can be moved to archive Ensure availability of the final versions of records as defined in the electronic TMF (eTMF) Universe (all systems that hold TMF relevant records during or after the trial) including Clinical Operations (CO) as well as Biometrics, Data Managements and Statistics (BDS) on an ongoing basis during the conduct of the CT. Records can be in paper or electronic format

Skills:

Excellent organizational and communication skills Structured mindset in the approach of complex administrative tasks Excellent time management with the ability to prioritize Commitment to obtaining results and problem solving Proficiency with Windows, MS Office (Word, PowerPoint, Excel, Outlook) Proficiency in written and spoken English and (local language)

Knowledge and Experience:

Experience in Clinical Operations preferred Excellent knowledge in use of eTMF systems Advanced knowledge of ICH-GCP and Good Documentation Practice, applicable SOPs, WIs, local procedures and List of Essential Elements

Education:

High School Diploma required; Post Secondary/High School education in Business Administration or equivalent preferred

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