Global Trial Associate- Global Clinical Operations Leadership Development Program (GCOLDP)- Full-Time Class of 2025

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Position Summary:

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.

Principal Responsibilities:

• 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

Education and Experience 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., 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 requires 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.

• 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

The anticipated base pay for this position is $93,000/year, this position is eligible for a sign-on bonus.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs:

• Medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

• Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).

• This position is eligible to participate in the Company's long-term incentive program.

• Employees are eligible for the following time off benefits:

• Vacation - up to 120 hours per calendar year

• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year

• Holiday pay, including Floating Holidays - up to 13 days per calendar year

• Work, Personal and Family Time - up to 40 hours per calendar year

For additional general information on Company benefits, please go to: https://https://www.careers.jnj.com/employee-benefits

This job posting is anticipated to close on at 11:59pmEST on December 31st, 2024. The Company may however extend this time-period, in which case the posting will remain available on https://https://www.careers.jnj.com to accept additional applications.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.