Job Function: R&D Operations
Job Sub Function: Clinical Trial Project Management
Job Category:People Leader
All Job Posting Locations:La Jolla, California, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America
Job Description:We are searching for the best talent for a
Sr. Manager, Trial Delivery Leader.Purpose: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.
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 Behaviors.
Qualifications / Requirements:Education: Bachelor's degree is required. Preferred areas of study include Life Sciences (Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
Required: - 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 muti-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
Required Skills:Preferred Skills:Budgeting, Clinical Trial Designs, Clinical Trials, Compliance Management, Contract Management, Developing Others, Execution Focus, Fact-Based Decision Making, Inclusive Leadership, Laboratory Operations, Leadership, Process Improvements, Productivity Planning, Project Integration Management, Research and Development, Research Ethics, Resource Planning, Team Management
The anticipated base pay range for this position is :$137,000.00 - $235,750.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company's long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation -120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
Holiday pay, including Floating Holidays -13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave - 80 hours in a 52-week rolling period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
