You have a first experienced with TMF records and would you like to join our pharma client, who is looking to reinforce the their team. Do you have a first experience in the clinical /healthcare field ? Additionally, you are fluent in English, Dutch and/or French ? Then this may be for you !
The TMF Records Specialist (TRS) is a member of the core trial team and is responsible to provide operational expertise to the core trial team, oversees the implementation of the TMF (Trial Master File) 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.
The TRS closely collaborates with the core trial team to create, implement and maintain the list of trial-specific expected records. This includes the identification of all relevant trial level records required to reconstruct the trial, independent of owner or system hosting the record. The TRS is responsible for the planning, tracking, formal QC and filing of all TMF trial level records according to internal and external standards and also to initiate the close out of the TMF.
The TRS shares the status to the core trial team on the completeness, quality and timeliness of the TMF during the entire life cycle of the trial.
Establish Sponsor File Records
Create, finalize and communicate Trial-Specific List of Expected Records (LoER)
- Participate as appropriate in Trial Oversight Meetings and present TMF topics.
- Create the trial-specific LoER in collaboration with the core trial team.
- Review the draft trial-specific LoER and obtain input from the trial team.
- Finalize and communicate the final trial-specific LoER to CT Manager and LTRS.
Update the trial-specific LoER if a main trial event is planned/occurs that has an effect on trial records (e.g. CTP amendment) and communicate to CT Manager and LTRS.
Facilitate communication with CT Manager and LTRS according to Client processes
Maintain Trial Master File throughout trial
Process and file trial level records in TMF
- Collect, file or 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) on an ongoing basis during the conduct of the CT. Records can be in paper or electronic format.
- Perform quality checks for all trial level records and resolve any discrepancies prior to filing.
- Process trial level records according to whether they are expected or unexpected as per trial specific LoER:
File expected trial level records in TMF
In case of unexpected trial level records update the LoER.
Oversee TMF status for assigned trial in regards to completeness, timeliness and quality and take appropriate action if the TMF does not fulfill the requirements
- Share in the monthly meeting with the CT Leader the TMF status of the trial.
Conduct Completeness and Timeliness Reviews of Trial Master File (Trial level)
Perform regular reviews for completeness and timeliness of the TMF on trial level during CT conduct and provide feedback to the responsible party.
- Track TMF completeness and timeliness against the trial-specific LoER.
- Escalate any issues requiring resolution to the CT Leader and follow up on issue resolution.
- Share TMF status with trial team.
Close out Trial Master File
- Create the final list of trial, country and site-specific exceptions with input from the LTRS.
- Inform the CT Leader about the list of exceptions on trial level regularly and finally when all records are received.
- Confirm the archiving prerequisites have been met with input from LTRS before the TMF can be moved to archive
Fully outsourced trials
* Provides input into TMF Operational Plan and TMF related CRO processes
* Minimum Education/Degree Requirements: Administrative qualification or equivalent by experience
* Regulatory and / or Organisational Requirements: Act in compliance to internal and external standards (e.g. ICH-GCP, Good Documentation Practice, SOPs, WIs and local procedures). *
Required Capabilities (Skills, Experience, Competencies):
- Good skills in: communication (cultural-sensitive, clear and transparent), conflict management, negotiation, team work
- Excellent English communication skills in writing, speaking and reading.
- Ability to prioritize.
- Capable of performing TMF activities relevant for the respective role during CT life cycle.
- Experience in working in an international/intercultural/cross-functional environment.
- In-depth knowledge of International Conference on Harmonization (ICH) regulations and Good Clinical Practice (GCP), Good Documentation Practice and understanding of legal / regulatory environment concerning sponsor TMF and ISF management.
- Ideally 2-5 years documentation management experience, including knowledge of clinical trials life cycle and associated flow of records at any stage of the CT.
- Knowledge of ICH-GCP, Good Documentation Practice and document filing requirements.
- Balanced salary package based on your skills and experience