About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries work on teams that save lives by developing the medicines of tomorrow, developing treatments, finding cures, and pioneering the path from lab to life.
Learn more at https://www.jnj.com/innovative-medicine
About the Role
We are searching for the best talent for the Global Trial Associate- Global Clinical Operations Leadership Development Program (GCO-LDP)- Full-Time Class of 2027.
Purpose: The GCO Leadership Development Program consists of 12 months of dynamic rotations in Spring House, PA. The Program provides in-depth training across the Clinical Trial Assistant, Site Manager, and Local Trial Manager roles based on business need, supported by strong line management, formal mentorship, sponsorship, networking, focused leadership development and dynamic real-world work experience.
Global Trial Associates (GTAs) will rapidly gain knowledge, develop technical and leadership skills and important insights into how the business operates. The Site Manager rotation will be in the Immunology, Neuroscience-Cardiovascular (NSC) or Oncology Therapeutic Areas. The LTM and CTA positions will not be in the Oncology Therapeutic area.
The objective is for the GTA to develop an understanding of pharmaceutical development, GCO standard operation procedures, policies and regulatory requirements, logistical and administrative tasks related to trial management (start-up, execution and closing phases) and patient safety in clinical trials.
Upon successful completion of the program, GTAs will be placed in a Site Manager role or potentially a Local Trial Manager role depending on business need and skillset. The GCO US Site Management organization is regionally aligned to the East, Central and West, which reduces the travel burden for Site Managers as they are assigned to study institutions based in their region. Local Trial Managers work remotely and are not regionally aligned as they don't have travel associated with their position; LTMs are project managers responsible for study deliverables in the US. Following completion of the program, GTAs moving into the SM role will work remotely in an assigned region in the U.S., where there is a business need.
Responsibilities
•Provide administrative and logistical support to Clinical Trial Assistants (CTAs), Site Manager and/or Local Trial Manager in tracking progress of the trial, management of study data, budget, organizing meetings, mailing and correspondence, materials, drug distribution and other relevant tasks as appropriate in adherence to relevant SOPs, policies, and local regulatory requirements.
•Support the local study team in performing site feasibility and/or country feasibility. Collaborate with the Global Project Team, e.g. Trial Delivery Manager (TDM)/Trial Delivery Lead (TDL), local management/Country Head and other study team members, as required.
•Maintain information in relevant systems, including electronic filing (electronic Trial Master File: vTMF).
•Ensure current versions of the required trial documents, trial-related materials and supplies are provided to the investigational site within required timeframes, as applicable.
•Support Site Manager and/or Local Trial Manager in collecting/preparing documents required for study start-up/submission to Ethics Committee/IRB and/or Health Authorities.
•Support Site Manager and/or Local Trial Manager in collecting, processing, and archiving study related documents as appropriate. Use appropriate systems to ensure file completeness at designated study milestones.
•May assist team in conducting local investigator meetings or with planning for investigators participating in an international meeting.
•Maintain and update contact information in relevant systems to ensure appropriate safety updates distribution.
•Comply with all training requirements, company policies & procedures and all applicable laws and regulations. Always act aligned with J&J Credo.
•Ensure inspection readiness at all times.
•May contribute to process improvement.
•Support Site Manager, within a reasonable timeframe, by being able to take on responsibility in executing activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to Standard Operating Procedures, Work Instructions (WIs) and policies.
•Support ad hoc requests from the Manager Clinical Operations (MCO) based on business needs, including accompanied site visit preparation, inspection readiness activities, regulatory document review, and other operational support as required.
Qualifications / Requirements
•Must be graduating between June 2026 and June 2027 with a bachelor's or master's degree (e.g., BA, BS, MS) in Health Sciences or a related scientific field (PhD/Pharm D or Pre-Med applicants will not be accepted)
•Ability to start in July 2027
•Minimum GPA of 3.6 is required
•1+ year of professional work experience is preferred (including internship, co-op or research experience)
•Ability to relocate to Spring House, PA and work full-time (hybrid 3 days on-site/2 days remote) for the duration of the 1-year program
•Upon successful completion of the one-year program and selection into a permanent role, candidates will transition into either a Site Manager or Local Trial Manager position based on business needs and available opportunities. Candidates placed into a Site Manager role must be willing to relocate to one of the pre-identified locations: Texas, California, Illinois, Florida, or Pennsylvania. Relocation assistance will not be provided.
•Ability to travel as needed in the Site Manager rotation
•Permanently authorized to work in the United States; must not require sponsorship of an employment visa (e.g., H-1B or green card) at the time of application or in the future. Students currently on CPT, OPT, or STEM OPT usually require future sponsorship for long-term employment and do not meet the requirements for this program unless eligible for an alternative long-term status that does not require company sponsorship.
Skills
•Strong verbal and written communication and presentation skills
•Analytical and a real problem solver; willingness to learn in a dynamic environment and stay abreast of new technologies
•Strong interpersonal, leadership, and negotiating skills
•Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment; ability to perform activities in a timely and accurate manner
•Expert proficiency with Word, PowerPoint, Excel
•AI literacy and an AI-enabled mindset, including the ability to apply AI tools responsibly in daily work to improve productivity, decision making, and quality of outcomes
Preferred skills: Analytical Reasoning, Analytics Dashboards, Business Behavior, Clinical Data Management, Clinical Research and Regulations, Clinical Trial Designs, Clinical Trials, Execution Focus, Laboratory Operations, Medical Knowledge, Process Oriented, Professional Ethics, Project Integration Management, Project Management, Research and Development, Research Ethics, Training Administration
