Senior Clinical Trial 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 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 https://www.jnj.com

Job Function:
R&D Operations

Job Sub Function:
Clinical Trial Project Management

Job Category:
Professional

All Job Posting Locations:
Leeds, West Yorkshire, United Kingdom

Job Description:

Johnson & Johnson MedTech | General Surgery are looking for a Senior Clinical Trial Leader, remote role for the UK R&D Operations team.

Role Purpose:

This individual will be responsible for leading one or several clinical trials within the Johnson & Johnson MedTech General Surgery Clinical Operations group, as well as fostering strong, productive relationships with colleagues across the organization. Serves as the trial leader for clinical study execution.

What you will be doing:

1. Serve as a Senior Clinical Trial Leader within the Clinical Operations group to execute company sponsored clinical trials for the MedTech Surgery Franchises.
2. Manage all operational activities of assigned clinical studies and clinical activities.
3. Accountable for quality, compliance with regulations and company procedures, timelines, and budgets for assigned clinical trials.
4. Serve as a member of the clinical trial/study core team and may serve as the liaison with the Clinical Franchise and Clinical BSDM team for projects under their responsibility.
5. Solve problems with support from Clinical Management arising during clinical study execution, and seek guidance for more complex problems, as needed.
6. Provide internal communication of important clinical data and events. Functions as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders.
7. Plan and track assigned projects budgets to ensure adherence to business plans.
8. Identify and ensure strategies, resources, and accountabilities are in place to achieve rapid, high-quality execution of assigned clinical trials under their responsibilities.
9. Provide leadership within a clinical trial, ensuring that each team member has a well-defined set of activities and objectives specific to their role and responsibilities within the context of their business focus.
10. Ensure efficient use of resources within the clinical study/program to provide high quality deliverables.
11. Reviews and provides feedback on clinical operation section of protocols with supervision.
12. May mentor or train new clinical trial staff.
13. Support the development and implementation of new clinical systems and processes. Participates in departmental or cross-functional initiatives.
14. Responsible for communicating business related issues or opportunities to next management level.
15. Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
16. For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.
17. Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
18. Performs other duties assigned as needed.

1. Bachelor's degree or equivalent experience, preferably in Life Science, Physical Science, Nursing, or Biological Science, is required.
2. Some previous experience in clinical trial management or equivalent is required; global experience would be a plus.
3. Medical device experience a plus.
4. Budget management experience a plus.

1. Requires understanding of Good Clinical Practices.
2. Understanding and application of regulations and standards applied in clinical areas/regions is required.
3. Written and oral communication skills.
4. Demonstrated competencies in the following areas are required:
5. Leadership in a professional and ethical manner.
6. Technical writing skills.
7. Relevant industry certifications a plus (i.e., CCRA, RAC, CDE).

1. Location varies. Position can be performed remotely.
2. 10% domestic travel required, Leeds office twice a year is usual.

1. Responsible/manages: Clinical trial contractors as applicable.
2. Reports to Staff Clinical Trial Leader/Manager, Clinical Trials/Senior Manager, Clinical Trials/ Director, Clinical Operations.
3. Frequent coordination with cross functional partners including Clinical Franchise, Biometrics, Medical Affairs, Regulatory Affairs, HEMA, R&D, Medical Operations etc.
4. Interface and collaborate with site personnel, IRBs/ECs, Competent Authorities/MoH, and contractors/vendors.
5. Serve as contact point for Clinical Investigators and external Clinical/Surgical Subject Matter Experts.