Local Trial Manager
IQVIA
Date: 3 weeks ago
City: Petaling Jaya
Contract type: Full time
Responsibilities:
- Partner with global and local study team to provide high level country strategy and drive country level study delivery.
- Plan, manage, and maintain oversight of country-level clinical study execution in accordance with the global program strategy, through leadership of the cross-functional local study team.
- Drives key decisions and monitor the execution of the clinical study against timelines, deliverables, and budget for the assigned country.
- 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.
- Contribute to development of program/study-specific materials – e.g., monitoring plan, study specific training documents.
- Accountable for site-level goal setting and study-specific deliverables for clinical sites within the assigned country.
- Contribute to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
- Contribute to, deliver and/or lead CRA, Investigator and Study Coordinator training.
- Delivers competent vendor management at the country level to support the study, including review and approval of local vendor invoices and managing the local study supply. May submit requests for vendor services and support vendor selection.
- Contribute to the study-level forecast for study supplies, support study level accountability and reconciliation across assigned countries, management of ELE (enrolment long-range estimates) process.
- Monitor and escalate country and study trends in timely manner.
- Review and approve visit reports.
- Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyse trial progress.
- Identify and facilitate resolution of cross-functional study-specific issues.
- Communicate study progress and issues to study management teams and Quality & Compliance team.
- Ensure high standards for study monitoring by conducting quality local trial team meetings and facilitating CRA training where necessary (i.e. implementation of study amendment-and changes in study related processes).
- Prepare country and site-specific informed consent in accordance with procedural document, templates and applicable regulations.
- Safeguard trial subject safety by ensuring AEs/SAEs/PQCs are reported within the required reporting timelines and documented, as appropriate.
- Maintain inspection readiness by ensuring timely uploading of complete and accurate essential documents in systems utilized for trial management (e.g. CTMS and eTMF).
- Comply with relevant training requirements and maintain adequate therapeutic knowledge required for specified role and responsibilities.
- Work closely with CRA to ensure CAPA is implemented for audits/inspections or any quality related visits.
- Perform and/or oversee EC/HA submission and approvals in cooperation with the local study team.
- Ensure accurate finance reporting and trial delivered within budget by adhering to finance reporting deliverables and timelines. This includes forecasting and proactive management of country/local trial budget. If applicable, may assist in negotiation of trial site contracts and budgets.
- Conducts on-site quality visits with CRAs where/when appropriate and supports the maintenance of investigator site relationships.
- May contribute as a trainer of systems/processes or provide input to functional area process initiatives, if applicable.
- Bachelor’s degree in a healthcare or other scientific discipline
- Minimum 2-3 years’ local /regional trial project management experience
- Knowledge / expertise of local regulatory environment, study start up process and associated timelines etc.
- Clinical trial processes and operations
- Extensive knowledge of ICH/GCP regulations and guidelines
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