Working Opportunity as Senior Local Trial Manager at Johnson & Johnson
Johnson & Johnson, through its operating companies, is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices markets. Johnson & Johnson strives to provide scientifically sound, high quality products and services to help heal, cure disease and improve the quality of life. The organization is comprised of more than 250 operating companies with over 127,000 employees located in some 60 countries. With Global sales of USD 71.3 billion in 2013, Johnson & Johnson is recognized as one of the most admired and respected companies in the world. Johnson & Johnson companies are equal opportunity employers.
Post : Senior Local Trial Manager
Performs the role of Local Trial Manager (LTM) including operational oversight from start-up through to database lock and closeout as described in Cross-Pharma and GCO procedural documents. At the LTM III level, a LTM III is typically given assignments that are more complex or have a greater impact on business results. May perform the role of Global Trial Manager (GTM) for single country Medical Affairs studies as described in GCO procedural documents. LTM is the person in Trial Co-ordination and Site Management responsible for the local management of a trial (or Medical Affairs data generation activity) 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 leading and coordinating the local trial team for –the delivery of 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 other LTMs.
- Is responsible for country do-ability (if applicable) and site feasibility assessment in conjunction with CTA (if applicable), SM and GTM. 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 CPL, GTM, local management/Country Head and Protocol Owner to select final site list..
- Contributes input to the development of 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 Share points). 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.
- May submit requests for vendor services and may support vendor selection.
- May lead negotiation of trial site contracts and budgets. Forecasts and manages country/local trial budget to ensure accurate finance reporting and trial delivered –within budget. Adheres to finance reporting deliverables and timelines.
- 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 GTM and FM as needed
- Reviews and approves site and local vendor invoices as required
- Works with SM to ensure CAPP is implemented for audits and inspection or any quality related visits
- Complies with relevant training requirements.
- Act as local expert for assigned protocols. Develops strong therapeutic knowledge to support roles and responsibilities. May represent Global Clinical Operations 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 Clinical Trial Administrators, Site Managers and other LTMs.
- May represent functional area in process initiatives.
- Contributes to optimization of daily processes.
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