Johnson & Johnson Careers
TRIAL MANAGER | JANSSEN SP
São Paulo, Brazil
Clinical Trial Administration
Requisition ID: 8843190405
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Janssen Research & Development, a member of the J&J Family of Companies, is recruiting a Trial Manager (Coordenador de Pesquisa Clínica), located in São Paulo, Brazil at Medical Affairs Operations (MAO) offices. Janssen Research & Development develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.
The Trial Manager is a person within Trial Coordination and Site Management responsible for the management of clinical trials in Latin América ensuring deliveries in terms of timelines, quality and enrollment.
• Is responsible for country do-ability (if applicable) and site feasibility assessment in conjunction with Clinical Trial Assistant (CTA), Site Manager (SM) and Global Trial Manager (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 Clinical Program Leader (CPL), GTM, local management and Protocol Owner to select final site list.
• Initiates development of the Trial Plan, Safety Monitoring Plan, Filing and Archiving Plan and Investigational Product documents at a country/study level.
• Leads and coordinates local trial team activities in compliance with GCDO Standard Operating Procedures (SOP), Work Instructions (WI) and applicable regulations. Leads local/regional 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 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 analyzetrial progress
• Monitors country/study 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.
• Lead negotiation of trial site contracts and budgets. Forecasts and manages country/study trial budget to ensure accurate finance reporting and trial delivered –within budget. Adheres to finance reporting deliverables and timelines.
• Coordinates/attends/participates in Investigator Meetings as needed.
• Conducts 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 Functional Manager (FM) as needed
• Reviews and approves site and 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.
• Acts as local/regional expert for assigned protocols. Develops strong therapeutic knowledge to support roles and responsibilities. May represent Medical Affairs Operations on cross functional teams.
• Acts as primary country/study 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.
• Actively contributes to process improvement; training and mentoring of Clinical Trial Administrators, Site Managers and other TMs.
• Roles and interactions:
- The Trial Manager reports to the Clinical Program Leader (CPL).
- Partner with the CTAs, SMs, Quality&Compliance Managers/Experts, Contracts and Grants associates, GTM, Medical Affairs local and regional,protocol owners anddata management to ensure overall trial coordination and site management activities for assigned protocols.
- External Interfaces: Trial Site Personnel, external vendor representatives
• A minimum of 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.
• Previous experience managing clinical trials is preferred.
• 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 in Portuguese and English. Spanish is desirable.
• Good written and oral communication skills.
Willingness/ availability to travel around 20% is a pre-requisite for this position.
Brazil-São Paulo-São Paulo-
Janssen Cilag Farmaceutica Ltda. (7585)
Clinical Trial Administration