Local Trial Manager
Found in: beBee S GB - 2 weeks ago
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and sophisticated diseases of our time.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases.
We are seeking a Local Trial Manager (LTM) to report to the Clinical Research Manager (CRM), running assigned clinical trials in the UK. You will have operational oversight of assigned protocols from start-up through to database lock. Responsibility for coordinating and leading the local trial team to deliver quality data and trial documents that are aligned with Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory standards.
The LTM will actively contribute to process improvement; training and mentoring of Clinical Trial Assistants (CTA) and Site Managers (SM) roles. The LTM may have some site management responsibilities.
Principal Responsibilities:
- Collaborate with the CRM for country protocol feasibility (if applicable) and site feasibility assessment. Implement 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. Recommend suitable sites for selection participating in trials. Set predictable and realistic start up time lines.
- Lead and coordinate trial activities in compliance with SOPs, other procedural documents and regulations. Lead local project planning activities to meet recruitment targets and to deliver high quality data on time and within budget. Including: development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.
- Acting as the Assigned Protocols subject matter expert. Develop strong therapeutic knowledge to support roles and responsibilities.
- Acting as primary country contact for a trial. Establishes and maintains excellent working relationships with external organisations, in particular investigators, study trial coordinators and other site staff; and internal partners, including Medical Affairs.
- Ensuring that the safety of trial patients is at the forefront. Ensure Adverse Events /Serious Adverse Events /Product Quality Complaints are handled within the required reporting timelines and detailed as appropriate.
- Supervising country progress and initiate Corrective and Preventive Action when the trial deviates from plans. Identify and resolve issues.
- We may ask you to assist in negotiation of trial site contracts and budgets. Forecasts and handles local trial budget to ensure accurate finance reporting and trial delivered within budget. Adheres to finance reporting results and timelines.
- Encouraging and empowering trial teams to deliver on the trial commitments.
- Review and approve Monitoring Visit Reports submitted by SM; identifies issues and/or trends across a trial project.
- Keep patient engagement central to all activities. Preparing c ountry specific informed consent in accordance with PD's and templates.
- Prepare IRAS submissions and responsibility for approvals during the trial.
- Ensure that studies are Inspection ready .Works with SM to ensure CAPA is implemented for audits and inspections or any quality related visits.
- Conducts accompanied site visits with SM as delegated.
- Contribute and encourage process improvement at every opportunity.
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Local Trial Manager
Found in: beBee jobs GB - 2 weeks ago
High Wycombe, Buckinghamshire, United Kingdom Johnson & Johnson Full timeLocal Trial ManagerAt the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and sophisticated diseases of our time. Janssen Research & Development, LLC discovers and develops innovative medical solutions to address...
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