"Alerted.org

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:

Spring House, Pennsylvania, United States of America

Job Description:

J&J IM - Trial Delivery Manager

J&J Flex – 3 days office/2 days remote – International Locations

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

Netherlands, Germany, France, Belgium- Requisition Number: R-045529

United Kingdom - Requisition Number: R-047381

United States - Requisition Number: R-047393

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Company overview:

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

Position Summary:

The Lead, Trial Delivery Management (TDM) is responsible for the execution of study-level activities, creating and updating trial-specific documents, vendor oversight & delivery, compound training, and other activities. The TDM is responsible for country and regional oversight of local operational delivery, including the alignment of the feasibility strategy and target setting, risk reviews and local challenges that could impact overall study delivery.

Principal Responsibilities:

+ Develop and update critical trial-specific documents (e.g., Monitoring Guidelines, Informed Consent Form, Investigational Medicinal Product [IMP] related documentation).

+ Manage vendor set up and management of day-to-day study vendor activities, including set-up, SOW creation and budget oversight.

+ Responsible for country / regional coordination of trial management activities and oversight (e.g., aligns feasibility strategy with local teams, perform country-level risk reviews, aware of all projects conducted across countries).

+ Support development of program-level compound training, collaborating with Clinical / CTL&D / Medical writing.

+ Provide input into trial level operational strategies.

+ Resolve trial-related issues and mitigate trial-related risks.

+ Participate in process improvement activities at a trial, compound & cross-DU level, as needed.

+ Provide support during Health Authority inspections and on the identification of risks and mitigation plans at the program level for key issues.

+ Mentor & support onboarding of new team members, particularly those in Trial Management.

Education and Experience Requirements:

Required Minimum Education:

BS degree or equivalent, preferred areas of study include Life Sciences (Life Sciences (e.g., Biology,

Chemistry, Biochemistry, Nursing, Pharmacy) Required **Years of Related Experience:**

Minimum of 4 years clinical trial experience in Pharmaceutical, Healthcare or related industries.

Required Knowledge and Experience:

+ Clinical research operational knowledge and experience across multiple phases of studies (Phase I-IV); must have the ability to manage multiple aspects of execution of a clinical trial.

+ 2-3 years’ experience supporting multiple aspects of a global clinical trial.

+ Must possess excellent leadership skills and proven track record to foster efficiency & teamwork.

+ Experience leading without authority and in muti-functional and global environments.

+ Excellent decision-making, analytical and strong financial-management skills are essential to this position.

+ Operate and implement with limited supervision. Experience mentoring/coaching others.

+ Strong project planning/management, communication and presentation skills are required.

Other:

Percentage Travelled:

Travel up to 15-20% of the time, defined by business needs.

Benefits:

The anticipated base pay range for this position is $152,000 to $174,800

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)).

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://www.careers.jnj.com/employee-benefits

_The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market._

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

\#LI-Hybrid

Required Skills:

Clinical Trial Oversight, Trial Management, Vendor Management

Preferred Skills:

Analytical Reasoning, Clinical Research and Regulations, Clinical Trial Designs, Clinical Trial Management Systems (CTMS), Clinical Trials, Communication, Data Savvy, Laboratory Operations, Organizing, Problem Solving, Productivity Planning, Professional Ethics, Project Integration Management, Quality Assurance (QA), Regulatory Compliance, Research and Development, Research Ethics, Standard Operating Procedure (SOP)

The anticipated base pay range for this position is :

Additional Description for Pay Transparency: