Senior Local Trial Manager

Overview

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

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R&D Operations

Clinical Trial Project Management

Professional

Raritan, New Jersey, United States of America, Remote (US)

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at

We are searching for the best talent for a Senior Local Trial Manager to be located remotely in the United States. A pre-identified candidate for consideration has been identified. However, all applications will be considered.

A Senior, Local Trial Manager is a mid-level trial management role with typically at least 2 years of clinical trial management or 3-5 years of clinical monitoring experience. This role is responsible for local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries. The Senior, Local Trial Manager is the primary point of contact at a country level for assigned studies and has operational oversight of assigned protocol(s) from start-up through to database lock and closeout activities as described in GCO procedural documents.

The role coordinates and leads the local trial team to deliver quality data and trial documents/records that are compliant with the assigned clinical trial protocol, company SOPs, GCP, and regulatory requirements. The Senior, Local Trial Manager contributes to process improvement; training and mentoring of CTAs, SMs and Associate Local Trial Managers. The role may have some site management responsibilities and may perform the role of Trial Delivery Manager/Trial Delivery Leader for single-country assignments in line with GCO procedures.

• Collaborate with Functional Manager (FM)/Clinical Research Manager (CRM) for country protocol feasibility and site feasibility assessment with CTA/SM and TDM/TDL. Implement local site criteria and ensure consistent conduct of Site Qualification Visits, with follow-up of Site Qualification Visit reports and country feasibility reports. Recommend suitable sites for trial participation.
• Collaborate with the Program Delivery Leader (PDL), TDM/TDL, local management/Country Head and other study team members to select the final site list.
• Contribute to study management documents at country level or initiate development for a single-country trial, as per SOPs.
• Lead and coordinate local trial team activities in compliance with SOPs and regulatory requirements. Lead local planning to meet recruitment targets and deliver high-quality data on time and within study budget. Develop local trial-specific procedures and tools, recruitment plans, risk management, and budget forecasting.
• Ensure timely reporting of Adverse Events (AEs)/Serious Adverse Events (SAEs)/PQCs and document appropriately.
• Maintain and update trial management systems and use study tools to analyze progress.
• Monitor country progress and initiate CAPAs when deviations occur; communicate progress to study management teams.
• May submit vendor service requests and support vendor selection; may assist in negotiating trial site contracts and budgets. Forecast and manage country/local trial budget to ensure accurate finance reporting and on-budget delivery.
• Attend or lead Investigator Meetings as needed; present and facilitate sessions and discussions.
• Conduct local trial team meetings and provide or facilitate SM training…