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Senior Site Manager Early Development, High Wycombe
Client: Johnson and Johnson
Location: High Wycombe, United Kingdom
Job Category: Other
EU work permit required: Yes
Job Reference:
55c8026a7d59
Job Views:
4
Posted:
28.04.2025
Expiry Date:
12.06.2025
Job Description:
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
All Job Posting Locations: High Wycombe, Buckinghamshire, United Kingdom
Position Overview:
We are searching for a Senior Site Manager, Early Development (Senior Clinical Research Associate/Senior CRA), to serve as the primary contact between the Sponsor and Investigational Site for complex early development and/or clinical pharmacology studies. The role involves ensuring inspection readiness and compliance with protocols, SOPs, GCP, and regulations from start-up through data lock. Responsibilities include site assessments, selection, initiation, monitoring, and close-out, collaborating with various trial team members. The position is field-based with regular in-office requirements, located in High Wycombe, Buckinghamshire.
Responsibilities:
* Manage site feasibility, selection, initiation, and monitoring activities in compliance with regulations.
* Act as primary contact for sites, address issues, and ensure progress and data accuracy.
* Implement risk-based monitoring strategies and collaborate on recruitment and retention plans.
* Ensure proper training, supplies management, and handling of investigational products.
* Oversee data entry, query resolution, and documentation.
* Report adverse events, maintain files, and ensure inspection readiness.
* Partner with stakeholders to drive performance and quality.
* Mentor colleagues, contribute to process improvements, and support initiatives.
Qualifications:
* 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 hematology, is a plus.
* Strong understanding of GCP, local laws, and regulations.
* Proficiency with IT systems and databases.
* Ability to work remotely with a home office setup.
* Excellent communication, influencing skills, and ability to work independently.
* Willingness to travel up to 50%, including overnight stays.
We offer a competitive salary, extensive benefits, flexible working environment, and career development opportunities. Johnson & Johnson is an equal opportunity employer committed to diversity and inclusion. Reasonable accommodations are available for individuals with disabilities upon request.
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