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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:
Johnson & Johnson is currently seeking an Operations Specialist, Patient & Site Engagement to join our Global Development Oncology Delivery Unit located in High Wycombe, UK.
The Patient & Site Engagement (PSE) Operations Specialist serves as the primary contact for trial teams, responsible for managing, executing, and delivering patient and site-facing initiatives in support of clinical trials. This role involves interfacing with key stakeholders within the Global Development Organization (GD), including Program Delivery Leaders (PDL), Trial Delivery Leaders (TDL), Clinical Trial Managers (CTM), Local Trial Managers (LTM), and Site Managers (SM), as well as external suppliers and other relevant stakeholders.
Services/Deliverables:
* Maintain visibility of Oncology pipeline to ensure appropriate patient recruitment & retention support of relevant programs and studies
* Provide patient and site insights to relevant teams to encourage thoughtful research design and execution
* Ensure that executed strategies meet compliance guidelines and are delivered on time and within budget.
* Work with the PSE Manager as appropriate to ensure program- and trial-level PSE deliverables are completed on schedule.
* Maintain a comprehensive library of tools and tactics in the virtual Trial Master File (vTMF), ensuring effective documentation of business processes and quality standards for tactic development.
* Document updates to the program- and trial-level PSE strategy, including the study overview deck.
* Adhere to Johnson & Johnson SOPs, WIs, policies, local regulatory requirements, and maintain compliance with relevant time reporting systems and training requirements.
* Accurately oversee the Scope of Work (SOW) for External Service Providers, managing PSE trial budgets and Purchase Orders proactively.
* Keep the project plan updated regarding timelines and budgets, aligned with the SOW for the delivery of tools and tactics for clinical trials.
* Drive the execution of tactics and initiatives through the management of service providers, including creative content development, global translations, material production, and the technical development of apps and websites to enhance patient/caregiver and site engagement.
* Support the PSE Manager in vendor activities such as budget tracking, filing, training, eMP requests, and issue logging.
* Document compliance reviews and approvals of tools and tactics, maintaining oversight for Institutional Review Board (IRB)/Ethics Committee (EC) approvals as needed.
* Facilitate clear communication with all stakeholders to ensure defined expectations, contributing to study meetings through facilitation, attendance, or presentation.
* Maintain a deep understanding and proficiency in finance and contracting systems relevant to the role.
* Ensure the delivery of presentations and workshop content at International Investigator Meetings, Ad Hoc face-to-face meetings, and similar engagements.
Metrics/KPIs:
Metrics/KPIs governing these services are outlined in the Quality Oversight Plan (QOP) document.
Interfaces:
* Primary Interfaces: Trial Delivery Leader, Study Responsible Physician/Scientist (SRP/S), Clinical Trial Manager (CTM)/Global Trial Manager (GTM), Local Trial Manager (LTM), Site Manager (SM), Janssen Research Procurement (JRP), Compliance Business Partners (HCC, RAP, Legal, Privacy).
* Other Interfaces: External Service Providers, Investigators, and Site Personnel.
Education and Experience Requirements:
* Education: BA/BS or equivalent, preferably in a scientific or health-related discipline.
* Experience: Minimum of 3 years of relevant experience in global patient recruitment, clinical trial execution or clinical research with a pharmaceutical company, CRO, or healthcare facility/research site.
Required Knowledge, Skills, and Abilities:
* Experience with drug development, clinical trial operations, and strategic planning.
* Experience in clinical trial operations, including developing patient recruitment strategies, ensuring patient recruitment material compliance, and support programs.
* Strong planning, tracking, customer focus, organization, and detail-oriented skills, capable of managing multiple projects successfully.
* Excellent time management, prioritization, and self-management skills, with strong project management capabilities.
* A strong team orientation, demonstrating initiative to solve problems and improve efficiency and customer service.
* High proficiency in Microsoft Excel, PowerPoint, Word, and Microsoft Project.
* Strong written and oral communication skills, with a good understanding of relevant software and company systems.
* Willingness to travel as needed.
Required Skills:
Preferred Skills:
Analytical Reasoning, Clinical Research and Regulations, Clinical Trial Designs, Clinical Trial Management Systems (CTMS), Clinical Trials, Communication, Data Savvy, Laboratory Operations, Organizing, Problem Solving, Productivity Planning, Professional Ethics, Project Integration Management, Quality Assurance (QA), Regulatory Compliance, Research and Development, Research Ethics, Standard Operating Procedure (SOP)