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Senior Site Manager (Sr. Clinical Research Associate) - Western
ATHALMER BC V0A1A0
Category: Other
  • Your pay will be discussed at your interview

Job code: lhw-e0-90477037

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Summary

  Job posted:   Sun Jun 3, 2018
  Distance to work:   ? miles
       
  3 Views, 0 Applications  
 
Senior Site Manager (Sr. Clinical Research Associate) - Western
Janssen
Pharmaceutical, a company of Johnson & Johnson is hiring a Senior Site
Manager. This position is a field based role covering primarily
British Columbia and Alberta; occasional travel outside
of the provinces as needed. The preferred locations are Vancouver, Calgary
and Edmonton.





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 the Global Clinical Operations (GCO) Canada
group and will be responsible for site management through the
assessment/selection, initiation, maintenance and closure phases of a clinical
trial (Phase 1 - 4).





+ Primary contact for the site; liaison with
study teams.


+ Proactively drive subject recruitment.


+ Monitor according to GCP standards and GCO
SOPs (to include source document verification, Trial Centre File review and accurate drug accountability).


+ Responsible for resolution of
site-specific issues and partnering with site to meet study milestones.


+ Work with in-house team to resolve
protocol-specific issues.


+ Site training, during site initiation and
ongoing, to ensure compliance with all required regulations, SOPs,
trial-specific tools and systems, and specialized procedures.


+ Maintain clinical trial tracking system
(CTMS); update electronic Trial Master File (eTMF) as
required.





Qualifications





+ A minimum of a B.Sc., R.N., or equivalent
degree is required, preferably in Biological Sciences.


+ A minimum of 3 years' experience
monitoring pharmaceutical industry clinical trials is required.


+ Knowledge of several therapeutic areas is
an asset, oncology preferred.


+ Ability to operate and proactively use
various systems and databases (e.g. CTMS, eDC, eTMF, various
dashboards/metrics, IWRS, safety reporting).


+ Analytical risk-based monitoring
experience highly desirable.


+ Environment to establish a home office.


+ Strong communication and influencing
skills to effectively manage study sites both remotely and face to face. Team
player, self-starter with ability to work independently.


+ In-depth knowledge of Good Clinical
Practice, ICH guidelines and local regulatory requirements.


+ Willingness to travel up to 50% (up to
2-3 days per week) with overnight stays (up to 1-2 nights on average), is
required.





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.


Primary Location

Canada-British Columbia-Vancouver

Other Locations

North America-Canada-British Columbia, North America-Canada-Alberta-Calgary, North America-Canada-Alberta, North America-Canada-Alberta-Edmonton

Organization

Janssen Inc. (7710)

Job Function

Clinical Trial Administration

Requisition ID

7212171215


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