Local Trial Manager II (LTM II) is responsible for local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries. The LTM II 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 II 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.
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. Implements 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. Recommends suitable sites for selection to participate in trial.
Collaborates with the Global Product Lead (GPL), CTM/GTL, local management/Country Head and other study team member to select final site list.
Contributes input to the study management documents at a country level or initiates development of these documents for a single country trial, as per SOPs
Leads and coordinates local trial team activities in compliance with SOPs, other procedural documents and applicable regulations. Leads local project planning activities to meet recruitment targets and to 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.
Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs)/Product Quality Complaints (PQCs) are reported within the required reporting timelines and documented as appropriate.
Maintains and updates trial management systems.
Monitors country progress and initiates corrective and preventive actions (CAPA) when the trial deviates from plans and communicates study progress and issues to study management teams.
May submit requests for vendor services and may support vendor selection.
Attends/participates in Investigator Meetings as needed. May schedule and conduct a local/country investigator meeting
Conducts local trial team meetings and provides or facilitates SM training when needed (i.e. implementation of study amendment-and changes in study related processes).
Reviews and approves Monitoring Visit Reports submitted by SM; identifies issues and/or trends across a trial project and escalates deviation issues to the CTM/GTL and FM as needed
Reviews and approves site and local vendor invoices as required. Manages local study supply, as required.
Prepares country specific informed consent in accordance with procedural document/templates. Reviews and manages site specific informed consent forms in accordance with SOPs, other procedural documents and applicable regulations.
Organizes and ensures IEC/HA approvals, if applicable, and ensure that the trial is in compliance with local regulatory requirements
Works with SM to ensure CAPA is implemented for audits and inspection or any quality related visits
Acts as subject matter expert for assigned protocols. Develops strong therapeutic knowledge to support roles and responsibilities. May represent GCO on cross functional teams.
Acts as primary local/country contact for a trial. Establishes and maintains 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 contributes to process improvement, training and mentoring of CTAs, SM and other LTMs.
Conducts accompanied site visits with SM as delegated by FM.
A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required.
Minimum two to four years of pharmaceutical and/or clinical trial experience is preferred (including site monitoring experience).
Solid understanding of the drug development process including GCP and local regulatory requirements.
Willingness to travel with occasional overnight stay away from home.
Solid leadership skills. Solid communication and computer skills required.
Proficient in speaking and writing the country language and English language.
Some experience in mentoring/coaching and providing training to other LTMs, SMs and CTAs preferred.
Flexible mindset and ability to work in a fast-changing environment.
Janssen Pharmaceutica N.V. (7555)