Lead, Trial Delivery Management (1 of 3)

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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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:

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

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):

United States - Requisition Number: R-057753

Japan - R-059626

United Kingdom - R-059552

Switzerland - R-059564

Belgium, France, Netherlands, Spain, Italy, Germany, Poland - Requisition Number: R-059569

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

This is a remote role available in all states within the United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.

Remote work options may be considered on a case-by-case basis and if approved by the Company.

We are searching for the best talent for Lead, Trial Delivery Management.

The Lead, Trial Delivery Manager (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:

• Create 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.

Required Minimum Education: Bachelor’s degree or equivalent, preferred areas of study include Life Sciences (Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing,