Job OverviewThe Trial Master File (TMF) Analyst is responsible for management of sponsor TMF structure and records in the system and provides day to day operational support to the sponsor clinical trial teams on TMF structure management, TMF Quality review and inspection readiness.Essential Functions, includes but not limited to:Responsible for management of expected TMF structure and records in the sponsor TMF Platform.Able to create sponsor TMF platform (Veeva Vault) file plan for document requirement.Maintenance of expected number of documents in sponsor eTMF by performing activities such as support in management of signposts.Perform TMF quality and completeness review.Support inspection readiness activities as needed.Collaborate with the other teams/roles in sponsor organization for creating of training materials and job aids.Support issue resolution in collaboration with other teams, identify gaps and escalate if required to follow up and close the identified gaps and issues.QUALIFICATION
- Bachelor's degree, preferably in a scientific discipline, is required.
- Demonstrated proficiency with TMF Management.
A minimum of 4 to 5 years of experience with eTMF system/platform.
- Must have strong knowledge of DIA Reference Model for TMFs, ICH GCP knowledge, regulatory requirements, and regulations.
- Strong knowledge of eTMF platforms (Veeva Vault is preferred).
- Understands the reports and complexity of study life cycle milestones in Veeva Set up, EDL management, tailoring.
- Working knowledge of clinical research documents.
- Demonstrated current knowledge of ICH, GCP, and other regulatory guidance as applicable to management of clinical documentation.
- Ability to work in an extremely fast-paced environment with changing priorities.
- Ability to work collaboratively and cross-functionally.
- Attention to detail and accuracy in work.
- Skilled in verbal and written communication skills.
- Experience in Microsoft Office suite.
Competency in Microsoft Excel is added advantage.#J-18808-Ljbffr