Johnson & Johnson Careers
Senior Site Manager-Quebec
Quebec, Canada; Montréal, Canada
Clinical Trial Administration
Requisition ID: 0937181224
Janssen Inc, a company of Johnson & Johnson is hiring a Senior Site Manager. This position is a field based role covering primarily Quebec; occasional travel outside of the provinces as needed.
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, metabolic and chronic diseases and women’s health. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen Inc. is a member of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit www.janssen.ca for more information.
The Senior Site Manager will be part of our Global Clinical Operations (GCO) Canada group and you will be responsible for study site management through the assessment/selection, initiation, maintenance and closure phases of a clinical trial (Phase 1 – 4 trials).
- You are the primary point of contact for the study site; liaison with study teams.
- Your responsibilities include actively identifying and driving patient recruitment strategies at assigned sites
- You are responsible for monitoring the study/site according to GCP standards and our Janssen GCO SOPs, both on-site and with remote contacts. This includes source document verification, Trial Centre File review and accurate drug accountability.
- You will provide site training, during site initiation and ongoing, to ensure compliance with all required regulations, SOPs, trial–specific tools and systems, and specialized procedures.
- You will ensure resolution of site-specific issues and will partner closely with investigator and site staff to meet all of our study timelines.
- You will work closely with the local study operations team to resolve protocol and site specific issues.
- You will use and maintain the clinical trial tracking system (CTMS) and update the electronic Trial Master File (eTMF) as required.
- You have a minimum of a B.Sc., R.N., or equivalent degree, preferably in Biological Sciences.
- You have a minimum of 3 years’ experience in monitoring pharmaceutical industry clinical trials
- Analytical/risk-based monitoring experience is highly preferred.
- Having a knowledge of several therapeutic areas is an asset (ideally including oncology)
- You will need to have an in-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements.
- You have the ability to operate and use various systems and databases (e.g. CTMS, eDC, eTMF, various dashboards/metrics, IWRS, safety reporting).
- You have the environment to establish a home office.
- Bilingual in French and English is required.
- You possess strong communication and influencing skills to effectively manage study sites both remotely and face to face. Strong team member and self-starter with the ability to work independently.
- You may need to travel up to 50% (up to 2-3 days per week) with overnight stays (up to 1-2 nights on average).
Diversity and inclusion are central elements of the shared culture across the Johnson & Johnson Family of Companies. Attracting, developing and retaining a workforce that reflects the diversity of our customers and communities is essential to our success. We are committed to providing a respectful, inclusive and accessible work environment where all employees have the opportunity to achieve their potential.
Janssen Inc. (7710)
Clinical Trial Administration