Clinical Trial Specialist

Clinical Trial Specialist
Aveiro
Aveiro, Aveiro District, Portugal

Summary:

Participates in electronic QC and indexing of TMF documents as required.

Utilizes TMF tools and technology to accomplish tasks without supervision.

Proficient in TMF management and can train others.

Leads the compilation of the TMF Management Plan and TMF Index in association with the TMF Owner and CROs.

Leads the development of TMF technology and tools to accomplish tasks.

Regularly trains others on TMF process and provides input on overall training strategy.

Participate in policy/procedure development and drafting.

Manage Helpdesk queries through to resolution within appropriate timeframes.

Serve as TMF SME to study teams and functions.

Ensure that the clinical trial documentation is consistent with the Trial Master File specifications, applicable SOPs, ICH/GCP guidelines and other regulatory agencies requirements.

Ensure the Trial Master Files are inspection ready.

Ensure Trial Master File study specifications are in alignment with program strategy and milestones.

Develop consistent setup and maintenance of Trial Master File requirements, processes and program.

Ensure that documentation flow for Trial Master File documents meet the required timelines and intervene with action plans and follow up as appropriate.

Act as the point of contact for audits/inspections related to the Trial Master File processes and activities and assist with the development of corrective action plans related to Trial Master File findings.

Review data quality outputs and audit outputs to identify trends per study and across programs.

Develop metrics for performance tracking and document trends for improvement processes of Trial Master File reviews.

Manage study setup in the e
TMF System on a timely basis for studies assigned and communicate same to end users