Trial Manager Brazil

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**TRIAL MANAGER**
**Position Summary**:
**Accountable for leading the execution of managed access program in Brazil and other latin America countries ,** for project(s) assigned by the Global Program Leader, Functional Manager, or Operations Head. This includes all project activities starting from Request for Services and high-level budget estimate through protocol development to delivery of final Clinical Study report (CSR) or other deliverable(s), according to planned milestones, within budget, and with high quality standards per company procedures and regulatory requirements.
- Serves as the single point of end-to-end accountability for assigned project(s); leads the Study Management Team (SMT) for local studies, interfaces with the Clinical Teams, GD functions, stakeholders from local Medical Affairs or other internal trial sponsors, external service providers e.g. contract research organization (CRO) and/or other J&J enterprise sectors, as applicable.
- Responsibilities include but are not limited to project activities starting from protocol development to delivery of final Clinical Study report (CSR) or other deliverable(s), as well as driving issue identification and resolution and contingency planning, all according to planned milestones, within budget, and with high quality standards per company procedures and regulatory requirements
**Principal Responsibilities:
**- Lead the SMT as the single point of accountability for end-to-end project management, including high level budget estimate, protocol development, trial set-up, execution, close-out, analysis and reporting. - For projects executed in-house, oversee and support Site Managers, GCO-LTM (if assigned) and other team members in the daily operational activities in line with country specific regulations and internal processes, if required. - For projects outsourced to a CRO, oversee and monitor the CRO’s performance on all contracted services.
- Prepare or contribute to high level budget estimate in response to Request for Services followed by detailed budget proposal.
- Lead vendor assessment and selection in consultation with appropriate representatives of the operating company.
- Ensure accurate project budget management and tracking according to plan. Update project account with scope changes, if any. Version 2.0 dated 14APR2020(FINAL) Job ID: : Job Code: R&D, JOB SUBFUNCTION Central Trial Coordination (PG26), Trial Leader MAO Page 2 of 3 For Internal Use Only
- Accountable for delivery of assigned trials within agreed/projected life of trial budget. Ensure accurate trial budget management and tracking, updates for scope changes and reconciliation of costs, as applicable. Responsible for overall contract management, including review & approval of external service provider (ESP) contracts, change orders and ensures services are delivered per contract.
- Track project progress against planned timelines and monitor patient recruitment rate to ensure that target enrolment will be met across the allocated regions/countries.
- Provide regular status updates to SMT, project owners and Clinical Team members. Ensure required reports are generated and available for real time tracking of project status.
- In coordination with the Functional Manager/GPL, Study Responsible Scientist/Physician (SRS/SRP) and/or Clinical Leader, provide adequate project-specific training to the GCO or CRO teams and to the site staff. Works with GCO/CRO staff in the set-up and coordination of Investigator Meetings, if applicable.
- Maintain project compliance within all applicable Health Authority (HA) regulations, guidelines, internal SOPs and processes. Ensure quality oversight of assigned projects utilizing the available tools so that the project is in a constant state of inspection-readiness. Participate in preparation for, and conduct of, HA inspections and internal Quality Assurance (QA) audits.
- Identifies and proactively manages issues in a timely manner by communicating regularly with the Functional Manager/CPL/COH; escalating issues and managing risks related to resources, timelines and budgets. Build proposal for Action Plan(s) with the SMT to implement solutions on a project level.
**Qualifications**
At Johnson & Johnson, the largest healthcare company in the world, we come together with one purpose: to profoundly change the trajectory of heal

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