Think Beyond The Label Jobs

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 MedTech, 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. Learn more at https://www.jnj.com

Job Function:

R&D Operations

Job Sub Function:

Clinical Trial Project Management

Job Category:

Professional

All Job Posting Locations:

US026 PA Spring House - 1400 McKean Rd

Job Description:

About Innovative Medicine

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 https://www.jnj.com/innovative-medicine

A pre-identified candidate for consideration has been identified. However, all applications will be considered.

We are searching for the best talent for the Global Trial Associate, Global Clinical Operations Leadership Development Program (GCO LDP)- Full-time 2025 role to be in Spring House, PA.

Purpose:

The GCO Leadership Development Program consists of 12 months of dynamic rotations in Spring House, PA with in-depth training across the Clinical Trial Assistant, Site Manager, and Local Trial Manager roles, 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 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.

The GTA will gain knowledge of and support activities of the Site Manager (SM) and Local Trial Manager (LTM) positions under the direct supervision of LTM and SM mentors, Program Manager, and/or Functional Manager (FM).

Upon successful completion of the program, GTAs will be placed in either a Local Trial Manager or Site Manager role depending on business need and skillset. The GCO US Site Management organization is regionally aligned to the Northeast, Southeast, Central and West. This 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.

You will be responsible for:

• Provide administrative and logistical support to Clinical Trial Assistant (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. Collaborates with the Global Project Team, e.g. Clinical Trial Manager (CTM)/Global Trial Lead (GTL), local management/Country Head and other study team members, as required.

• Maintain information in relevant systems, including electronic filing (electronic Trial Master File: eTMF).

• 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 Clinical Trial Manager, 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 Clinical Trial Manager, 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 meeting or with planning for the 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, be 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.

This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned.

Qualifications / Requirements:

• Must be graduating between July 2024 and July 2025 , with a Bachelor’s or Master’s degree (e.g., BA, BS, MS), in Health Sciences or a related scientific field (we will not be accepting PhD/PharmD applicants)

• Minimum GPA of 3.2 is required

• 1+ plus year of professional work experience preferred (including internship, co-op or research experience)

• Must be permanently authorized to work in the U.S. and must not require sponsorship at the time of hire or in the future

• 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

• Geographic flexibility to relocate within the U.S. following completion of the program, if there is a business need

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, Power Point, Excel.

Travel:

• Ability to travel up to 25% in Site Manager rotation

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.