As a TMF Specialist, you will be the Trial Master File (TMF) Subject Matter Expert and advisor for the Clinical Study Assistants (CSA), and other TMF stakeholders to ensure a complete and accurate TMF through documentation quality. You will provide crucial TMF quality support to the Clinical Study Team. Establish a proactive quality-focused partner-relationship with the Clinical Study Team.
- Act as TMF Subject Matter Expert;
- Support Clinical Study assistants (CSA) and Leaders (CSL) in the set-up and maintenance of an (electronic)TMF for assigned studies:
- Set-up eTMF for each new study including prepare eTMF Table of Content at study start and update as appropriate during a study in agreement with the Clinical Study Team.
- Maintain Study Specific Expected Document Lists at study, country and site levels by collaborating with all relevant stakeholders (e.g. Data Management, Clinical, Regulatory, etc.) to ensure placeholders are correctly and accurately in place for the study and all versions are filed in a timely fashion.
- Create, in collaboration with CSA and CSL, the study specific TMF Plan (describing set-up and maintenance activities, and responsibilities, Quality Control & Review activities, management of paper originals, scanning processes etc)
- Support multifunctional Clinical Study Teams in the management of study documentation (including uploading documents in eTMF, scanning, managing paper originals) ensuring a complete, contemporaneous and quality study TMF.
- Support Clinical Study Teams and other relevant TMF stakeholders in understanding their TMF-related responsibilities, requirements and expectations; act as an ad-hoc member of the Study Team
- Conduct appropriate Quality Checks on TMF documents,
- Conduct Quality Review in vendor TMF systems
- Provide reports and metrics on completeness and quality of TMF documentation and content to CSL on regular basis; take the appropriate relevant actions to address gaps, issues and risks
- Maintain a study tracking of Trial Master File locations during study and upon archiving, e.g. the company’s TMF, vendor TMFs
Support final QCs of the company’s TMF and vendor TMF.
- Escalate any issues regarding TMF content, quality and follow-up to CSL and TMF Owner.
- Ensure proper archiving of TMF components from all relevant stakeholders
- Support the Study Team in TMF document retrieval during Audits and Inspections (paper and electronic)
- Ensure smooth transfer of vendor TMF components into eTMF and proper archiving full eTMF
- Perform inventory activities for off-site storage records (old studies), as appropriate
- Graduate or Degree in administration, office management or scientific degree
- Minimum 3 years clinical research experience with relevant exposure to and knowledge of TMF Reference Model, ALCOA+ standard, Good Documentation Practices or relevant working experience in pharmaceutical/scientific environment: i.e. thorough understanding of the processes associated with the conduct of clinical studies and document management operations
- Experience/knowledge of ICH/GCP E6(R2) guidelines on documentation requirements
- Ability to establish and maintain cooperative relationships, and work effectively with all levels of personnel on TMF management issues across multidisciplinary teams globally
- Have at least intermediate Microsoft Office (Excel, PowerPoint, Word, Outlook, Excel) knowledge
- Ability to remain calm/focused in high-stress situations and maintain a high level of accuracy and attention to detail in fast-paced environment with shifting priorities
- Be flexible, pro-active, self-motivated and able to work independently with minimal supervision. Be able to prioritize and seek input where necessary
- Good verbal and written communication skills
- An attractive salary in line with your experience and skills.
- Fringe benefits including a medical insurance, pension plan and a care plan.
- A supporting environment.
- Respect for the life-work balance.
- Career planning.
- A focus on professional and personal growth through training and coaching.
- Room for personal engagement to help shape our company's future.