Join to apply for the Senior Site Manager Early Development role at Johnson & Johnson Innovative Medicine
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Join to apply for the Senior Site Manager Early Development role at Johnson & Johnson Innovative Medicine
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:
High Wycombe, Buckinghamshire, United Kingdom
Job Description
Senior Site Manager, Early Development (Senior Clinical Research Associate/ Senior CRA)
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 Senior Site Manager, Early Development (ED), located in the United Kingdom to serve as the primary contact point between the Sponsor and the Investigational Site for complex early development and/or clinical pharmacology studies. Responsibilities include site assessments, pretrial assessments, site selection, site initiation, subject recruitment and retention, monitoring, and close-out. The role involves ensuring inspection readiness and compliance with protocols, SOPs, GCP, and regulations from start-up through data-base lock. The position is field-based with regular in-office requirements, based in High Wycombe, Buckinghamshire. Experience in Haematology or Oncology is preferred but not mandatory.
Responsibilities include:
* Managing activities from site feasibility to close-out in compliance with SOPs, GCP, and regulations.
* Acting as the primary contact for sites, resolving issues, and ensuring progress and data accuracy.
* Implementing risk-based monitoring and collaborating on recruitment and retention strategies.
* Training site staff, managing supplies, and handling investigational products.
* Overseeing data entry, query resolution, and documentation.
* Reporting adverse events and maintaining inspection readiness.
* Partnering with stakeholders to ensure quality and address audit findings.
* Mentoring colleagues and contributing to process improvements and initiatives.
Qualifications / Requirements:
* BA/BS in Life Sciences, Nursing, or related field (or equivalent experience).
* At least 3 years of clinical trial monitoring experience preferred.
* Knowledge of therapeutic areas, especially Oncology or Haematology, is an asset.
* Strong understanding of GCP, laws, and regulations.
* Proficient in IT systems and databases.
* Ability to work independently and establish a home office.
* Excellent communication and influencing skills.
* Willingness to travel up to 50%.
We welcome applications from all qualified individuals and offer a competitive salary, benefits, flexible working, and career development opportunities. Johnson & Johnson is an equal opportunity employer and provides accommodations for individuals with disabilities.
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