Senior Manager, Trial Delivery Leader

Senior Manager, Trial Delivery Leader

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.

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:

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.

Position Summary:

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.

Principal Responsibilities:

• 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 activities at a trial, compound & cross-DU level, as needed.

Additional Responsibilities may Include:

• Lead and ensure inspection readiness for program through risk identification and readiness review.

• Provide leadership 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.

• Foster employee engagement, inclusion, and Credo Behaviors.

Principal Relationships:

Internal: DAS Leaders, Trial Management Directors, Clinical Trial Managers, Clinical Trial Assistants, representatives of Delivery Operations, representatives of other GD Functions and Clinical Teams

External:
Investigators

Education and Experience Requirements:

Required Minimum

Education:

BS degree or equivalent, preferred areas of study include Life…