Sr. Trial Manager, Early Development, Oncology

Johnson & Johnson•Spring House, PA

4d•Remote

About The Position

The Sr. Trial Manager, Early Development, Oncology is responsible for local management of clinical trials in one or more countries, serving as the primary country-level contact for assigned studies and ensuring delivery of quality data and trial records in compliance with the protocol, Good Clinical Practice (GCP), healthcare compliance requirements, standard operating procedures, and local regulations. The role performs Local Trial Manager (LTM) responsibilities across the trial lifecycle, from start-up through database lock and closeout. Depending on the study, the role may also perform Trial Delivery Leader (TDL) and Site Manager (SM) responsibilities under the Early Development and Clinical Pharmacology (ED&CP) hybrid oversight model. The position leads local trial teams and planning, monitors trial progress, recruitment, quality, timelines, and budget, and coordinates with internal study partners, sites, vendors, and regulatory bodies. It also contributes to process improvement, training, and mentoring. The role is remote in the United States and may require travel with occasional or regular overnight stays, depending on the region.

Requirements

A minimum of a BA or BS degree in Life Sciences, or equivalent experience.
Demonstrated AI literacy and an AI-enabled mindset, including the ability to use AI tools responsibly to improve productivity, decision-making, and quality of outcomes.
Solid understanding of drug development, ICH/GCP, and local regulatory requirements.
Good leadership skills.
Strong communication skills, including written and oral communication.
Proficiency in speaking and writing the relevant country language and English.
Strong IT skills with appropriate software and company systems.
Willingness to travel, including occasional or regular overnight stays away from home depending on the region.
Flexible mindset and ability to work at a fast pace in small exploratory international study teams in a changing environment.
Ability to work on multiple trials in parallel across different disease areas.

Nice To Haves

At least 2 years of clinical trial management experience in addition to site monitoring experience; other relevant experience and skills may be considered by the hiring manager.
Previous clinical trial experience in Early Development and Clinical Pharmacology (ED&CP).
Specific therapeutic-area experience or knowledge, depending on the position.

Responsibilities

Collaborate with the Functional Manager on study feasibility and site assessments, recommend suitable sites, follow up on pre-trial visit activities, and work with study partners to finalize site lists.
Contribute to country-level study management documents and initiate their development for trials using the ED&CP hybrid oversight model.
Lead and coordinate local trial team activities in compliance with company procedures and applicable regulations.
Lead local planning to meet recruitment targets and deliver high-quality data on time and within budget, including local procedures, recruitment plans, contingency and risk management, and budget forecasting as applicable.
Ensure Serious Adverse Events, Product Quality Complaints, and Suspected Unexpected Serious Adverse Reactions are reported and documented within required timelines.
Maintain and update trial management systems; use study tools, reports, and dashboards to analyze progress.
Monitor country and overall study progress, initiate corrective and preventive actions when needed, and communicate progress and issues to study leadership and teams.
Submit vendor service requests and support vendor selection as applicable; review and approve site and local vendor invoices.
Assist with site contract and budget negotiations and manage or collaborate on GCO budget forecasting and financial reporting.
Set up and conduct Investigator Meetings as applicable and collaborate with Site Managers on site initiation visits.
Conduct trial team meetings, facilitate Site Manager training, and build team competencies, including for study amendments and process changes.
Review and approve Site Manager visit reports within required timelines, identify trial-level trends or issues, and escalate concerns as needed.
Support implementation of the Analytical Risk-Based Monitoring model and help Site Managers develop action plans when data-entry timelines are missed.
Coordinate study supplies and ensure clinical drug supplies are handled, administered, and stored according to investigational product guidelines, in collaboration with relevant specialists and Site Managers.
Monitor site recruitment and collaborate with Site Managers on action plans for non-enrolling sites.
Prepare master and country-specific informed consent forms; review and manage site-specific forms in accordance with procedures and regulations.
Organize ethics committee and health authority approvals as applicable and ensure compliance with local regulatory requirements.
Work with Site Managers to ensure corrective and preventive actions are developed and implemented for audits, inspections, and quality visits.
Maintain required training, serve as an expert for assigned protocols, and develop therapeutic-area and early-development knowledge.
Act as the primary local GCO contact for assigned trials and maintain effective relationships with investigators, trial coordinators, site staff, and internal stakeholders.
Contribute to process improvement and train and mentor Site Managers and Clinical Trial Assistants.
Conduct accompanied site visits with Site Managers as delegated by the Functional Manager.
Represent GCO on cross-functional teams or take on additional initiatives, champion roles, or subject matter expert responsibilities as assigned.