The Local Trial Manager III (LTM III) is responsible for local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries.
The LTM III is the primary point of contact at a country level for assigned studies and has operational oversight of assigned protocol(s) from start-up through to database lock and closeout activities as described in GCO procedural documents.
The LTM III is responsible for coordinating and leading the local trial team to deliver quality data and trial documents/records that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements.
The LTM III role actively leads or contributes to process improvement; training and mentoring of other LTMs and Site Managers (SM).
Compared to LTM I and LTM II roles, an LTM III is often assigned to more complex protocols and can work across Phase 1 - 3 studies in multiple therapeutic areas as needed to drive business needs.
The Local Trial Manager III may also perform the role of Clinical Trial Manager (CTM)/Global Trial Lead (GTL) for a single country as described in GCO procedural documents.
Principal Responsibilities: Collaborate with Functional Manager (FM)/Clinical Research Manager (CRM) for country protocol feasibility (if applicable) and site feasibility assessment in conjunction with CTA (if applicable), SM and CTM/GTL.
Implement any local criteria for site selection.
Ensure consistent conduct of pre-trial assessment visits and instruct teams on appropriate follow-up of pre-trial visit report and country feasibility report.
Recommend suitable sites for selection to participate in trial.
Collaborate with the Global Product Lead (GPL), CTM/GTL, local management/Country Head and other study team members to select the final site list.
Contribute input to the study management documents at a country level or initiate development of these documents for a single country trial, as per SOPs.
Lead and coordinate local trial team activities in compliance with SOPs, other procedural documents and applicable regulations.
Lead local project planning activities to meet recruitment targets and deliver high quality data on time and within study budget, including but not limited to: development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.
Ensure that all Adverse Events (AE)/Serious Adverse Events (SAEs)/Product Quality Complaints (PQCs) are reported within the required reporting timelines and documented as appropriate.
Maintain and update trial management systems.
Use study tools and management reports available to analyze trial progress.
Monitor country progress and initiate corrective and preventive actions (CAPA) when the trial deviates from plans and communicate study progress and issues to study management teams.
Submit requests for vendor services and support vendor selection.
Assist in negotiation of trial site contracts and budgets, as needed.
Forecast and manage country/local trial budget to ensure accurate finance reporting and trial delivery within budget.
Adhere to finance reporting deliverables and timelines.
Attend/participate in Investigator Meetings as needed.
Schedule and conduct local/country investigator meetings.
Conduct local trial team meetings and provide or facilitate SM training when needed (i.e., implementation of study amendments and changes in study related processes).
Review and approve Monitoring Visit Reports submitted by SM; identify issues and/or trends across a trial project and escalate deviation issues to the CTM/GTL and FM as needed.
Review and approve site and local vendor invoices as required.
Manage local study supply, as required.
Prepare country specific informed consent in accordance with procedural document/templates.
Review and manage site specific informed consent forms in accordance with SOPs, other procedural documents and applicable regulations.
Organize and ensure IEC/HA approvals, if applicable, and ensure that the trial is in compliance with local regulatory requirements.
Work with SM to ensure CAPA is implemented for audits and inspections or any quality related visits.
Comply with relevant training requirements.
Act as primary local/country contact for a trial.
Establish and maintain excellent working relationships with external stakeholders, in particular investigators, study trial coordinators and other site staff; and internal stakeholders, including Medical Affairs and Marketing for Medical Affairs trials.
Actively lead or contribute to process improvement, training and mentoring of CTAs, SM and other LTMs.
Conduct accompanied site visits with SM as delegated by FM.
Assume additional responsibilities or special initiatives such as "Champion" or "Subject Matter Expert" as needed.
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