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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

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 is 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 to 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’.