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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

R&D Operations

Job Sub Function:

Clinical Trial Support

Job Category:

Professional

All Job Posting Locations:

Issy-les-Moulineaux, France

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 driven Senior Site Manager, located in Paris region Ile-de France (France) to serve as the primary contact point between the Sponsor and the Investigational Site for trials in phases 2 to 4, located France (Hybrid).

Purpose:

The position is within the Oncology-hematology therapeutic area and will include monitoring 2-3 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, Clinical Trial Manager (regional project manager) and Trial Delivery Leader.

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 French 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'.

Qualifications / Requirements:

• BA/BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience)
• A minimum of 3-5 years of clinical trial monitoring experience is preferred, however, other relevant working experiences and skills may be considered by the hiring manager
• Experience in sold oncology and/or hematology is preferred but not mandatory
• 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
• Commutability to Paris office required

Benefits:

We offer a competitive salary and extensive benefits package. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

France: The anticipated base pay range for this position is 44,100 to 71,070 euro on an annual basis. In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, and programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.

#LI-Hybrid

Required Skills:

Clinical Trials Monitoring

Preferred Skills:

Business Behavior, Business English, Clinical Data Management, Clinical Trials Operations, Execution Focus, Hematology and Oncology, Laboratory Operations, Mentorship, Proactive Behavior, Problem Solving, Process Improvements, Project Support, Regulatory Environment, Regulatory Inspections, Research and Development, Research Ethics, Study Management, Time Management

The anticipated base pay range for this position is:

€44,100.00 - €71,070.00

Benefits:

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.