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Senior Site Manager - British Columbia And Alberta
Company | Johnson & Johnson |
Address | Greater Edmonton Metropolitan Area, Canada |
Employment type | FULL_TIME |
Salary | |
Category | Hospitals and Health Care |
Expires | 2023-08-22 |
Posted at | 9 months ago |
- Primary point of contact for the study site; liaison with study teams.
- Use and maintain the clinical trial tracking system (CTMS) and update the electronic Trial Master File (eTMF) as required.
- Ensure resolution of site-specific issues and will partner closely with investigator and site staff to meet all our study timelines.
- Actively identify and drive patient recruitment strategies at assigned sites.
- Work closely with the local study operations team to resolve protocol and site-specific issues.
- Provide site training, during site initiation and ongoing, to ensure compliance with all required regulations, SOPs, trial-specific tools and systems, and specialized procedures.
- 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.
- Must have the ability to establish a home office.
- Strong computer skills in appropriate software applications and related clinical systems (e.g., CTMS, eDC, eTMF, various dashboards/metrics, IWRS, safety reporting) is required.
- A minimum of a Bachelor’s degree, Nursing degree (RN) or equivalent is required. A degree in Biological Sciences is preferred.
- Must be a strong team member and self-starter with the ability to work independently.
- 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.)
- Experience in Oncology, Early Development is preferred.
- A minimum of 3 years of experience with on-site and off-site (remote) monitoring is required.
- Knowledge of several Therapeutic Areas preferred.
- Must have strong communication and influencing skills to effectively manage study sites both remotely and face-to-face.
- Experience in the Pharmaceutical industry is preferred.
- The ability to partner closely with investigator and site staff to meet all study timelines is required.
- Experience with analytical/risk-based monitoring is highly 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.
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