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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 Details
Job Function: R&D Operations
Job Sub Function: Clinical Trial Support
Job Category: Professional
All Job Posting Locations: High Wycombe, Buckinghamshire, United Kingdom
Job Description
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. Our Oncology team is focused on the elimination of cancer by discovering new pathways and modalities to find treatments and cures. We lead where medicine is going and need innovators with an unwavering commitment to results. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Responsibilities
* Acts as primary local company contact for assigned sites for specific trials.
* May participate in site feasibility and/or site qualification visits.
* Responsible for delivering activities within site initiation and start‑up, preparation and conduct of site monitoring (including remote monitoring), site management (by study‑specific systems and other reports/dashboards) and site/study close‑out according to SOPs, Work Instructions (WIs) and policies. Implements the analytical risk‑based monitoring model at the site level and works with the site to ensure timely resolution of issues found during monitoring visits.
* Contributes to site‑level recruitment strategy and contingency planning and implementation, in partnership with other functional areas.
* Ensures accuracy, validity and completeness of data collected at trial sites.
* Ensures that all Adverse Events (AE) / Serious Adverse Events (SAEs) / Product Quality Complaints (PQCs) are reported within the required reporting timelines and documented as appropriate.
* Prepares trial sites for close‑out, conducts final close‑out visit.
* Tracks costs at site level and ensures payments are made, if applicable.
* Establishes and maintains strong working relationships with internal and external partners, in particular investigators, trial coordinators and other site staff.
Education and Experience Requirements
* A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required.
* Clinical trial monitoring experience is preferred; other relevant experiences and skills may be considered by the hiring manager.
* Oncology therapeutic area experience preferred (but not essential).
* Understanding of the drug development process including GCP and local regulatory requirements.
* Ability to work on multiple trials in parallel, if required.
* Proficiency in speaking and writing the English language.
* Excellent written and verbal communication.
* Willingness to travel > 50%, including overnight stays away from home.
Benefits
We offer a competitive salary and extensive benefits package. The health and well‑being of our employees is a priority; we have a flexible working environment as we value work‑life balance. We offer career development opportunities for those who want to grow and be part of our organisation.
EEO Statement
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will be considered for employment without regard to any other characteristic protected by law. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Required Skills
Clinical Trials Monitoring
Preferred Skills
* Analytical Reasoning
* Business Behavior
* Business English
* Clinical Data Management
* Clinical Trials
* Clinical Trials Operations
* Execution Focus
* Issue Escalation
* Laboratory Operations
* Process Improvements
* Process Oriented
* Project Support
* Regulatory Environment
* Research and Development
* Research Ethics
* Study Management
* Time Management
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