Senior Site Manager - Ontario
Janssen Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Site Manager (Senior Clinical Research Associate). This position is a field-based role covering primarily Ontario with occasional travel outside of this province as needed. Ideally, the Senior Site Manager should be located in the Greater Toronto Area.
At Janssen, we are dedicated to addressing and solving some of the most meaningful unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and metabolic and chronic diseases. Passionate about our dedication 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.
As a Senior Site Manager (Senior Clinical Research Associate), you will be part of our Global Clinical Operations (GCO) Canada group within Research & Development and will be responsible for study site management through the assessment/selection, initiation, maintenance, and closure phases of a clinical trial (Phase 1 - 4 trials).
- Primary point of contact for the study site; liaison with study teams.
- Actively identify and drive patient recruitment strategies at assigned sites.
- Monitor the study/site according to Good Clinical Practices (GCP) standards and our Janssen GCO Standard Operating Procedures (SOPs), both on-site and with remote contacts. This will include source document verification, Investigator Site File (ISF) review and accurate drug accountability.
- Provide site training, during site initiation and ongoing, to ensure compliance with all required regulations, SOPs, trial-specific tools and systems, and specialized procedures.
- Ensure resolution of site-specific issues and will partner closely with investigator and site staff to meet all our study timelines.
- Work closely with the local study operations team to resolve protocol and site-specific issues.
- Use and maintain the clinical trial tracking system (CTMS) and update the electronic Trial Master File (eTMF) as required.
- A minimum of a Bachelor’s degree, Nursing degree (RN) or equivalent is required. A degree in Biological Sciences is preferred.
- A minimum of 3 years of experience with on-site and off-site (remote) monitoring is required.
- Experience in the Pharmaceutical industry is preferred.
- Experience with analytical/risk-based monitoring is highly preferred.
- Knowledge of several Therapeutic Areas preferred.
- Experience in Oncology, Early Development is preferred.
- In-depth knowledge of Good Clinical Practices (GCPs), International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines and local regulatory requirements is required.
- Strong computer skills in appropriate software applications and related clinical systems (e.g., CTMS, eDC, eTMF, various dashboards/metrics, IWRS, safety reporting) is required.
- Must have strong communication and influencing skills to effectively manage study sites both remotely and face-to-face.
- Must be a strong team member and self-starter with the ability to work independently.
- Must have the ability to establish a home office.
- The ability to partner closely with investigator and site staff to meet all study timelines is required.
- Willingness to travel up to 50% is required. Onsite monitoring visits will be conducted in combination with offsite (remote) monitoring visits. You will be assigned sites mainly within your region/province, with occasional need for travel to neighboring provinces.
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