Local Trial Manager

Summary of the job: Performs the role of Local Trial Manager (LTM) including operational oversight of assigned protocol(s) from start-up through to database lock and closeout activities as described in GCO procedural documents. LTM is a person within Trial Co-ordination and Site Management responsible for local management of a trial (or Medical Affairs data generation activities) in a country or countries. The LTM is the primary point of contact at a country level for assigned studies. The LTM is responsible for coordinating and leading the local trial team in order to deliver quality data and trial documents/records that are compliant with assigned protocol, codes of Good Clinical Practice (GCP), Standard Operating Procedures (SOPs) and regulatory requirements. LTM actively contributes to process improvement; training and mentoring of Clinical Trial Assistants Site Managers and LTMs. The LTM may have some site management responsibilities. An LTM I usually performs principal responsibilities under the direct supervision of an LTM II or III and/or Functional Manager · Collaborates with the CPL, GTM, local management/Country Head and Protocol Owner to select final site list. · Contributes input to the Trial Plan, Safety Monitoring Plan, Filing and Archiving Plan and Investigational Product documents at a country level or initiates development of these plans for a single country trial. · 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 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 SAEs/PQCs are reported within reporting timelines and documented as appropriate. · Maintains and updates trial management systems (e.g. CTMS, eTMF/LAF, Trial Master Source and Sharepoints). Uses study tools and management reports available to analyze trial progress. · Monitors country progress and initiates corrective and preventive actions when the trial deviates from plans and communicates study progress and issues to study management teams. Qualifications Qualifications : A minimum of a BA/BS degree is required. A degree in a health or science related field is preferred. Minimum two to four years of pharmaceutical and/or clinical trial experience is preferred, however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate's eligibility. Specific therapeutic area experience may be required depending on the position. Should have solid understanding of the drug development process including ICH/GCP and local regulatory requirements. Solid communication and computer skills required. Proficient in speaking and writing the country language and English language. Good written and oral communication skills. Primary Location Hungary-Budapest-Budapest- Organization Janssen-Cilag Kft. (8396) Job Function R&D Requisition ID 2206050276W