Sr. Manager, Trial Deliver Leader
Johnson & Johnson
5 hours ago
Remote friendly (Raritan, NJ)
United States
Clinical Research and Development
Purpose
- Accountable for clinical trial delivery and operational oversight of cross-functional deliverables.
- Leads a cross-functional trial team to build and deliver the trial operational plan, identifying and mitigating risks to deliver assigned trials on time, on budget, and in a compliant manner.
You Will Be Responsible For
- Lead the Cross Functional Trial Team (CFTT) to influence and execute delivery of the operational plan and end-to-end trial execution.
- Accountable for overall trial delivery, including budget, timelines, quality, and milestones (e.g., support DBL/CSR/TLR planning and scope; define protocol deviations and resolution pathways).
- Proactively ensure trial deliverables and milestones are met.
- Identify risks and ensure mitigation/contingencies are initiated and followed through.
- Ensure trials are operationalized in compliance with global health authority regulations, guidelines, and internal operating procedures/processes.
- Identify risks in study conduct, develop mitigation plans, and escalate concerns to CT or CDT.
- Participate in preparation for and conduct of Health Authority inspections and internal QA audits.
- Maintain inspection-readiness; collaborate with R&D Quality for quality oversight.
- Participate in process improvement activities at trial, compound, and cross-DU level as needed.
Additional Responsibilities May Include
- Lead and ensure inspection readiness for program via risk identification and readiness review.
- Provide leadership during Health Authority inspections; address risks and mitigation plans at program level.
- Mentor and support onboarding of new team members (especially Trial Management).
- Foster employee engagement, inclusion, and Credo Behaviors.
Qualifications / Requirements
- Education: Bachelor’s degree (preferred Life Sciences: Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
- Minimum 8 years in Pharmaceutical, Healthcare, or related industries.
- Minimum 2 years’ experience leading multiple aspects of a global clinical trial.
- Knowledge of the pharmaceutical development process.
- Clinical research operational knowledge across Phase I-IV; ability to manage all aspects of execution of a clinical trial.
- Excellent leadership; ability to foster team productivity and cohesiveness.
- Experience leading without authority in multi-functional matrixed global environments.
- Strong decision-making, analytical, and financial management skills.
- Ability to operate with limited supervision.
- Experience mentoring/coaching others.
- Strong project planning/management and communication/presentation skills.
- Travel up to 15–20% as defined by business needs.
Preferred Skills
- Budgeting, Clinical Trial Designs, Clinical Trials, Compliance Management, Consulting, Contract Management, Execution Focus, Fact-Based Decision Making, Give Feedback, Industry Analysis, Laboratory Operations, Organizing, Process Improvements, Project Integration Management, Research and Development, Research Ethics, Technical Credibility
Benefits (time off)
- Vacation: up to 120 hours per calendar year.
- Sick time: up to 40 hours per calendar year (up to 56 hours for Washington residents).
- Holiday pay (including Floating Holidays): up to 13 days per calendar year.
- Work, Personal and Family Time: up to 40 hours per calendar year.
- Accountable for clinical trial delivery and operational oversight of cross-functional deliverables.
- Leads a cross-functional trial team to build and deliver the trial operational plan, identifying and mitigating risks to deliver assigned trials on time, on budget, and in a compliant manner.
You Will Be Responsible For
- Lead the Cross Functional Trial Team (CFTT) to influence and execute delivery of the operational plan and end-to-end trial execution.
- Accountable for overall trial delivery, including budget, timelines, quality, and milestones (e.g., support DBL/CSR/TLR planning and scope; define protocol deviations and resolution pathways).
- Proactively ensure trial deliverables and milestones are met.
- Identify risks and ensure mitigation/contingencies are initiated and followed through.
- Ensure trials are operationalized in compliance with global health authority regulations, guidelines, and internal operating procedures/processes.
- Identify risks in study conduct, develop mitigation plans, and escalate concerns to CT or CDT.
- Participate in preparation for and conduct of Health Authority inspections and internal QA audits.
- Maintain inspection-readiness; collaborate with R&D Quality for quality oversight.
- Participate in process improvement activities at trial, compound, and cross-DU level as needed.
Additional Responsibilities May Include
- Lead and ensure inspection readiness for program via risk identification and readiness review.
- Provide leadership during Health Authority inspections; address risks and mitigation plans at program level.
- Mentor and support onboarding of new team members (especially Trial Management).
- Foster employee engagement, inclusion, and Credo Behaviors.
Qualifications / Requirements
- Education: Bachelor’s degree (preferred Life Sciences: Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
- Minimum 8 years in Pharmaceutical, Healthcare, or related industries.
- Minimum 2 years’ experience leading multiple aspects of a global clinical trial.
- Knowledge of the pharmaceutical development process.
- Clinical research operational knowledge across Phase I-IV; ability to manage all aspects of execution of a clinical trial.
- Excellent leadership; ability to foster team productivity and cohesiveness.
- Experience leading without authority in multi-functional matrixed global environments.
- Strong decision-making, analytical, and financial management skills.
- Ability to operate with limited supervision.
- Experience mentoring/coaching others.
- Strong project planning/management and communication/presentation skills.
- Travel up to 15–20% as defined by business needs.
Preferred Skills
- Budgeting, Clinical Trial Designs, Clinical Trials, Compliance Management, Consulting, Contract Management, Execution Focus, Fact-Based Decision Making, Give Feedback, Industry Analysis, Laboratory Operations, Organizing, Process Improvements, Project Integration Management, Research and Development, Research Ethics, Technical Credibility
Benefits (time off)
- Vacation: up to 120 hours per calendar year.
- Sick time: up to 40 hours per calendar year (up to 56 hours for Washington residents).
- Holiday pay (including Floating Holidays): up to 13 days per calendar year.
- Work, Personal and Family Time: up to 40 hours per calendar year.