◆ The Local Trial Manager (LTM), in the Trial Lead Department, is responsible for the local management of a trial in a country or countries. The LTM is the primary point of contact for assigned studies at the country level. The LTM is responsible for leading and coordinating the local trial team and responsible for the delivery of quality data and trial documents/records that are compliant with assigned protocols, codes of Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and regulatory requirements.
◆ The LTM actively contributes to process improvement; experienced LTMs will train and mentor Site Managers (SMs) and other LTMs as needed. The LTM may have some site management responsibilities.
Undertakes assessments (country do-ability, if applicable, and site feasibility) in conjunction with the Clinical Trial Associate(CTA) team, and/or the SM and Japan Clinical Operational Leader(JCOL)/Clinical Trial Manager(CTM). Ensures consistent conduct during pretrial assessment visits and instructs teams on writing the follow-up pretrial visit report and country feasibility report. Selects and recommends suitable trial sites.
・Collaborates with the Japan Clinical Program Leader(JCPL) and JCOL/CTM in drawing up a final site list.
・ Assigns SM to sites after consultation with the Functional Manager(FM).
・ Cooperates with JCOL on the development of the SOP document, submitting elements that include (but are not limited to) the Safety Monitoring Plan, Filing and Archiving Plan, and Investigational Product documents at a country level.
・ Leads and coordinates local trial team activities in compliance with GCO Standard Operating Procedures (SOP), Work Instructions (WI), and applicable regulations.
Leads local project planning activities to meet recruitment targets and to deliver high quality data on time and within the study budget. This input includes, but is not limited to, the development of local trial specific procedures and tools, recruitment planning, contingency, and risk management, and budget forecasting.
・ Ensures that all SAEs/PQCs are reported within reporting timelines and documented as appropriate.
・ Maintains and updates trial management systems, but is not limited to, CTMS, eTMF/Country Level, Trial Master Source, and SharePoints. Uses all available study Monitors country progress and initiates corrective and preventive actions when the trial deviates from plans; communicates study progress and issues to study management teams.
・ May lead negotiations involving trial site contracts and budgets. Forecasts and manages the country/local trial budget to ensure accurate financial reporting and trial delivery within budget. Adheres to financial reporting deliverables and timelines.
・ Attends/participates in global Investigator meetings as needed. May schedule and conduct local/country investigator meetings.
・ Conducts local trial team meetings and provides or facilitates SM training when needed (for example, by implementing amendments or changes to study-related processes).
・ Reviews and approves the Monitoring Visit Reports submitted by SM; identifies issues and/or trends across a trial project and refers deviation issues to the JCOL and FM as needed.
・ Reviews site and local vendor invoices as required.
・ Works with SM to ensure that CAPA is implemented for audits and inspection, and for quality-related visits
・ Complies with relevant training requirements.
・ Acts as the local expert on assigned protocols. Develops a strong therapeutic knowledge to support other roles and responsibilities.
・ Acts as the primary local/country contact for a trial. Establishes and maintains excellent working relationships with external stakeholders, in particular investigators, study trial coordinators, other site staff, and internal stakeholders.
Actively contributes to process improvement; training and mentoring of CTAs, SMs and other LTMs.
・ Prepares country specific informed consent in accordance with GCO procedural document/templates with CTA. Reviews and manages site specific informed consent forms in accordance with GCO SOPs, WIs and all applicable regulations.
・ Acts as the local expert on regulatory affairs to ensure that the trial is in compliance with local regulatory requirements.
・ May also take on responsibility of SM if required
・ Organizes and ensures IEC/HA approvals and any import/export permits, if applicable.
Internal Interfaces: Functional Manager, Partner with the CTAs, SMs, Quality & Compliance Managers/Experts, Contracts and Grants Associates, JCOL/CTM, R&D study team (e.g., SRP), protocol owners, and Data Management and Medical Affairs teams (when applicable) to ensure overall trial coordination and implement site management activities in accordance with assigned protocols.
External Interfaces: Trial Site Personnel, external vendor representatives.
Supervision: This position reports to the Functional Manager
EDUCATION, EXPERIENCE & SKILL REQUIREMENTS:
A BA/BS degree is required.
A degree in a health or science-related field is preferred.
Specific therapeutic area experience may be required depending on the position.
Candidates should have a solid understanding of the drug development process, including ICH/GCP and local regulatory requirements. Solid communication and computer skills are required.
Must be proficient at speaking and writing both Japanese and English, with good written and oral communication skills.
Janssen Pharmaceutical K.K. (7195)