Sr. Trial Manager, Early Development, Oncology

Johnson & Johnson Innovative Medicine•Spring House, PA

5d•Remote

About The Position

The Sr. Trial Manager, Early Development, Oncology is responsible for local management of clinical trials in one or more countries and serves as the primary country-level contact for assigned studies. The role delivers quality data and trial documents and records in compliance with the clinical protocol, Good Clinical Practice (GCP), Healthcare Compliance Requirements, Standard Operating Procedures (SOPs), and local regulatory requirements. It performs Local Trial Manager (LTM) responsibilities, providing operational oversight from trial start-up through database lock and closeout. Depending on the study and its oversight model, the role may also perform Trial Delivery Leader (TDL) and Site Manager (SM) tasks. The Sr. Trial Manager coordinates local trial teams, supports feasibility and site selection, contributes to country-level study management documents, and plans trial delivery to meet recruitment, quality, timing, and budget goals. The role monitors trial progress and safety reporting, manages trial systems and documents, supports sites and vendors, and works with internal and external stakeholders. It also contributes to process improvement and provides training and mentoring to Site Managers and Clinical Trial Assistants. The position is remote in the United States, with travel and 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 responsible use of AI tools in daily work to improve productivity, decision-making, and quality of outcomes.
A solid understanding of the drug development process, including ICH/GCP and local regulatory requirements.
Good leadership skills and solid communication skills.
Proficiency in speaking and writing the country language and English.
Strong IT skills in appropriate software and company systems.
Willingness to travel, with occasional or regular overnight stays away from home depending on the region.
A 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 also be considered.
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 coordinate with study team members on the final site list.
Contribute to development of country-level study management documents or initiate their development for trials using the ED&CP Hybrid Oversight Model.
Lead and coordinate local trial team activities in accordance with GCO SOPs, procedural documents, and applicable regulations.
Plan local trial delivery to meet recruitment targets and deliver high-quality data on time and within budget, including local procedures and tools, recruitment planning, contingency and risk management, and budget forecasting where applicable.
Ensure Serious Adverse Events, Product Quality Complaints, and Suspected Unexpected Serious Adverse Reactions are reported within required timelines and documented appropriately.
Maintain and update trial management systems and use study tools, reports, and dashboards to analyze trial 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 needed; review and approve site and local vendor invoices where required.
Assist with negotiation of trial site contracts and budgets as needed, and collaborate on financial forecasting and budget management to support accurate reporting and delivery within budget.
Set up and conduct Investigator Meetings when applicable and collaborate with Site Managers on site initiation visits.
Conduct trial team meetings and provide or facilitate Site Manager training, including training on amendments and changes to study processes.
Review and approve Site Manager Visit Reports within required timelines, identify cross-trial issues or trends, and escalate deviations or issues as appropriate.
Support implementation of the Analytical Risk-Based Monitoring model where applicable and help Site Managers create action plans when data-entry timelines are not met.
Coordinate study supplies at country or study level as applicable, 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 and review and manage site-specific forms according to applicable procedures and regulations.
Organize IEC/HA approvals where 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 other quality-related visits.
Complete required training and act as an expert for assigned protocols, developing therapeutic-area and early-development knowledge and potentially representing GCO on cross-functional teams.
Act as the primary local GCO contact for assigned trials and maintain effective working relationships with investigators, trial coordinators, site staff, ED&CP contacts, and internal stakeholders.
Contribute to process improvement initiatives and train and mentor Site Managers and Clinical Trial Assistants.
Conduct Accompanied Site Visits with Site Managers as delegated by the Functional Manager.
Take on additional responsibilities or special initiatives, such as Champion or Subject Matter Expert roles, as assigned.