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 MedTech, 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. Learn more at jnj.com.
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Job Function:
R&D Operations
Job Sub Function:
Clinical Trial Project Management
Job Category:
Professional
All Job Posting Locations:
High Wycombe, Buckinghamshire, United Kingdom
Job Description:
About Innovative Medicine
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.
Learn more at https://www.jnj.com/innovative-medicine
We are searching for the best talent for a Sr. Manager, Trial Delivery Leader to be located in High Wycombe.
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):
United States - Requisition Number: R-067822
United Kingdom - Requisition Number: R-070509
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
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, 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
