Senior Manager, Trial Delivery Leader (1 of 7)

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

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

Purpose

The Senior Manager, Trial Delivery Leader (TDL) is accountable for clinical trial delivery, providing operational oversight of cross-functional deliverables for the Late Development or Early Development portfolio. 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.

You Will Be Responsible For

• 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 Behaviours.

Are you ready to join our team? Then please read further!

Qualifications / Requirements

• Education: Bachelor's degree is required. Preferred areas of study include Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
• Minimum of 8 years in Pharmaceutical, Healthcare or related industries.
• Minimum 2 years’ experience leading multiple aspects of a global clinical trial.
• Experience in and knowledge of the pharmaceutical development process.
• Clinical research operational knowledge and experience across multiple phases of studies (Phase I-IV); must have the ability to manage all aspects of execution of a clinical trial.
• Must possess excellent leadership skills and proven ability to foster team productivity and cohesiveness.
• Experience of leading without authority and in multi-functional matrixed and global environments.
• Excellent decision-making, analytical and strong financial management skills are essential to this position.
• Operate and execute with limited supervision.
• Experience mentoring/coaching others.
• Strong project planning/management, communication and presentation skills are required.
• Travel up to 15-20% of the time, defined by business needs

Benefits

We offer a competitive salary and extensive benefits package. The health and well-being of our employees is a priority, we have a flexible working environment as we value work-life balance. We offer career development opportunities for those who want to grow and be part of our organisation. For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com

Required Skills

• Clinical Trial Management
• Global Clinical Studies
• Project Planning
• Team Mentorship

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