Local Trial Manager

hace 2 semanas

Buenos Aires, Argentina IQVIA A tiempo completo

Local Trial Management services provides local management of a clinical trial (or Medical Affairs data generation activity) in the country. Services/deliverables include operational oversight of assigned protocol(s) at the country level from start-up through to database lock and closeout activities. Further, services will ensure the local trial team is delivering quality data and trial documents/records that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), International Conference on Harmonization for Good Clinical Practice (ICH-GCP), and regulatory requirements. Partners with the Clinical Trial Assistant (CTA)/Investigator Document Assistant (IDA), Clinical Research Associate (CRA) and Central Trial Manager (CTM)/Global Trial Manager to ensure overall study delivery at the country level.

**Responsabilities**:

- Complies with relevant training requirements.
- Contribute to quality Site Selection through participation in site feasibility ensuring consistent conduct of site qualification visits and appropriate follow-up of site qualification visit report and country feasibility report. Collaborates with central study team and local stakeholders as applicable for final selection of sites to participate in trial.
- Ensures local/country team is meeting recruitment targets with high quality data on time and within study budget by providing input to study level documents and leading/coordinating local team activities in compliance with SOPs, other procedural documents and applicable regulations. This may require development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.
- Act as primary company contact for assigned trial at the country level, may attend/participate in Investigator Meetings as needed. May schedule and conduct a local/country investigator meeting.
- Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress. When necessary, initiates corrective and preventive actions (CAPA) when the trial deviates from plans and communicates study progress and issues to study management teams and Quality & Compliance team.
- Contribute to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
- Delivers competent vendor management at the country level to support the study and may submit requests for vendor services and support vendor selection. This includes reviewing and approving site and local vendor invoices as required. As required, manages the local study supply.
- Ensures high standards for study monitoring by conducting quality local trial team meetings and facilitating CRA training, when needed (i.e. implementation of study amendment-and changes in study related processes).
- Contributes to patient understanding of protocol and patient safety by preparing country specific informed consent in accordance with procedural document/templates. This includes reviewing and managing site specific informed consent forms in accordance with SOPs, other procedural documents and applicable regulations

**Qualifications**:

- BA/BS degree.
- Degree in a health or science related field.
- 2 years of local trial management or mutually agreed clinical trial experience
- Advanced English

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