Senior Lead Recruiter - International Staffing
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 eTMF System on a timely basis for studies assigned and communicate same to end users.
Seniority level: Associate
Employment type: Full-time
Job function: Research
Industries: Pharmaceutical Manufacturing
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