Senior Site Manager

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 Support

Job Category: Professional

All Job Posting Locations: High Wycombe, Buckinghamshire, United Kingdom

Job Description:

Senior Site Manager, Oncology (Senior Clinical Research Associate)

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

About Oncology

Our Oncology team is focused on the elimination of cancer by discovering new pathways and modalities to finding 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. Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for a driven Oncology Senior Site Manager, located in the United Kingdom to serve as the primary contact point between the Sponsor and the Investigational Site for trials in phases 1b, 2 & 3.

Purpose:

The position is within the solid oncology therapeutic area and will include monitoring Lung, Bladder and Prostate cancer trials. As Senior Site Manager, you will be responsible for maintaining ongoing inspection readiness and compliance with the clinical trial protocol, Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations from study start-up through to site closure. Our new colleague should be flexible and able to work independently. We are seeking to hire a strong communicator, a quick learner, a problem solver, and a real team player. You will be responsible for oversight of clinical trial protocols at a site level and will collaborate closely with a Local Trial Manager (country project manager), Clinical Trial Assistant, and Clinical Trial Manager (regional project manager). You will be part of a hardworking, enthusiastic, and committed study team eager to deliver and help improve the lives of millions of patients. You will also be part of a wider local UK team that provides mutual support and opportunities to work together to identify new and improved ways of working.

You will be responsible for:

• Activities ranging from site feasibility and selection over site initiation and start-up, to preparation and conduct of site monitoring, oversight of key performance indicators and site/study close-out in complex clinical trials.
• The implementation of a site-level analytical risk-based monitoring model and for working with the site to ensure timely resolution of issues and deviations identified during monitoring visits.
• Ensuring the accuracy and completeness of all trial data including safety data. Managing timely data entry and query resolution in collaboration with site staff.
• Co-creating site-level recruitment and retention strategies and implementation of mitigation actions in partnership with other functional areas.
• Ensuring full documentation of trial related activities in all study files; communicates site and study progress and issues to the Local Trials manager and central study teams.
• Being the local expert in assigned protocols and build the necessary therapeutic area knowledge.
• Coaching or mentoring less experienced colleagues.
• You may participate in process improvement and training. Leads and/or participates in special initiatives as assigned. May assume additional responsibilities or special initiatives such as 'Champion' or 'Subject Matter Expert'.

Qualifications / Requirements:

• BA/BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience)
• A minimum of 2-3 years of clinical trial monitoring experience is preferred, however, other relevant working experiences and skills may be considered by the hiring manager
• Strong proven understanding of GCP, local laws, and regulations
• Strong IT skills in appropriate software and company systems
• Willingness to travel with occasional overnight stay away from home
• Proficient in local language(s) and English. Good written and oral communication skills

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 organization.

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.