Senior Manager, Trial Delivery Leader

R&D Operations

Clinical Trial Project Management

Professional

Spring House, Pennsylvania, United States of America

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 Med Tech, 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.

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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.

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.

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We are searching for the best talent for Senior Manager, Trial Delivery Leader.

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):

Requisition Number: R-1002001

Requisition Number: R-103345

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 cities within the USA 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.

The Sr. Manager, Trial Delivery Leader (TDL) is accountable for clinical trial delivery, providing operational oversight of cross-functional deliverables. The TDL leads a cross-functional team trial team to build and deliver the trial operational plan, identifying and mitigating risks to effectively deliver assigned trials on time, on budget and in a compliant manner.

• Responsible for leading the Cross Functional Trial Team (CFTT) to influence and execute delivery of the operational plan and for end-to-end trial execution.
• Accountable for overall trial delivery, budget, timelines, quality, and milestones (e.g., support DBL / CSR / TLR planning and scope, define protocol deviations and resolution pathways).
• Proactively ensure that trial deliverables and milestones are met.
• Identify risks and ensure mitigation and contingencies are being initiated and followed through.
• Ensure trial is operationalized in compliance with global health authority regulations and guidelines and internal operating procedures and processes.
• Accountable for identifying risks in study conduct, developing mitigation plans and escalating concerns to the CT or CDT.
• Participate in preparation for, and conduct of, Health Authority inspections and internal QA audits.
• Ensure that the trial team operates in a constant state of inspection-readiness, collaborating with R&D Quality to ensure quality oversight.
• Participate in process improvement…