Johnson & Johnson
Clinical Trial Leader - Remote
Clinical Trial Leader - Remote
Johnson & Johnson is the world's most comprehensive and broadly-based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical and medical devices & diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.
This individual will be responsible for managing and tracking the execution of Investigator-Initiated Studies within the External Research group as well as fostering strong, productive relationships with colleagues across the organization and investigative sites.
Duties and Responsibilities:
- Serve as a Clinical Trials Leader within the External Research group to manage and track Investigator-Initiated Studies for the Medical Device Franchises under supervision
- Serves as a member of the External Research team and may serve as the liaison with the Clinical R&D Franchise and Clinical Contracts/Payments for projects under his/her responsibility
- May serve as the primary contact for clinical investigative sites
- Manage and track the execution of operational activities of assigned Investigator-Initiated Studies within the External Research group
- Solves problems with support from Clinical Management arising during Investigator-Initiated Study execution, and will seek guidance for more complex problems, as needed
- Provide internal communication of important clinical milestones, data and events. Functions as a reliable trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders
- May be involved in other tasks to support External Research and R&D Clinical Franchise as needed
- Track assigned project budgets to ensure adherence to contract milestones
- Support the implementation of new clinical systems/processes, and provide support for publications, as needed.
- Interface and collaborate with investigative site personnel company personnel
- Ensure personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety, and Environmental compliance
- May assist with other External Research activities related to regulatory commitments, incl. but not limited to Data Use Agreements, Registry Engagements, Research Collaboration, and Collaborative Studies, as needed.
People Leadership Responsibilities:
- Ensure that all activities and decisions embody the Johnson & Johnson Credo Values.
- Provide oversight of Investigator-Initiated Study execution, 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.
- Ensure efficient use of resources within the Investigator-Initiated Study to provide high-quality deliverables.
Business Leadership Responsibilities:
- Accountable for the quality, compliance with regulations and company procedures, timelines, and budgets for assigned Investigator Initiated Studies.
- Identify and ensure strategies, resources, and accountabilities are in place to achieve rapid, high-quality execution of assigned Investigator-Initiated Studies under his/her responsibilities.
Functional and Technical Competencies:
- Requires understanding of Good Clinical Practices
- Understanding and application of regulations and standards applied in clinical areas/regions is required
- Presentation skills and influencing of others
- Written and oral communication skills
- Demonstrated competencies in the following areas are required:
- Behaving in a professional and ethical manner
- Technical writing skills
- Clinical Trial execution
- Project Management
- Excellent Communication skills
- Leadership required in alignment with J&J Leadership Imperatives:
- Connect - Develop collaborative relationships with key internal and external stakeholders, principally within allocated R&D Clinical Franchise teams and External Research department as well as the resource providers and vendors to create a strong and productive partnership
- Shape - Actively participate in departmental process improvement activities.
- Lead - Take ownership for the development of self and engage in transparent and constructive conversations.
- Deliver - Strive to ensure all deliverables on allocated Investigator-Initiated studies are met on time, within budget and in compliance to Contracts, SOPs and regulations.
- Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
- Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
- Performs other related duties as required.
- Minimum of a Bachelor’s/University Degree or equivalent required; preferably in Life Science, Physical Science, Nursing, or Biological Science.
- 2-4 years of relevant experience (or equivalent) required. (We will consider less for the right candidate)
- Previous experience in clinical trial management or equivalent is desired.
- Relevant industry certifications preferred (i.e., CCRA, RAC, CDE).
- Clinical/medical background a plus.
- Medical device experience is a plus.
In return for this role you will receive a very competitive hourly rate. A minimum 24 month contract & an opportunity to work with a Global Leader within the Pharmaceutical sector, Johnson & Johnson.
Please note the following before applying for the position:
- This role is remote however you MUST be UK based! We are not considering any applicants based anywhere else
- This role is INSIDE IR35 - PAYE & Umbrella options available
- The rate advertised is a PAYE rate, we do have a higher rate available for Umbrella
If you are interested in this role please apply now, or for more information contact Tabitha.Crabtree@randstadsourceright.co.uk