Clinical Research Associate Manager
Clinical Research Associate Manager
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
Job Description Summary
Location: Montreal/Toronto LI#HybridNovartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
About the role:
We are seeking a Clinical Research Associate (CRA) Manager with strong leadership and change management skills for the further development of CRAs into the site manager role. The CRA manager plays a crucial role in creating a collaborative culture to implement new ways of working and delivering quality in a multiple therapeutic area environment. The CRA Manager will be responsible for management of internal CRAs as well as working closely with Monitoring Services Oversight Manager to ensure the appropriate workload distribution and assignment for all CRAs while ensuring efficiency KPIs.
This role will work directly with the Monitoring Services Oversight Manager Portfolio Team Lead and Study Start up Team Lead and reports to the Study and Site Operations (SSO) Country Head Canada.
Job Description
Key responsibilities:
Supporting recruitment strategies and site performance by ensuring high quality and compliance of monitoring activities
Being accountable for monitoring quality timely data entry and issue resolution
Ensuring CRA monitoring competency gaps are identified and resolved through targeted training curricula in collaboration with training group as well as by performing comonitoring visits with training purposes
Promoting a compliance culture advocating the adherence to highest standards and ethical integrity ensuring human subject protection and reliability of trial results at all times
Actively managing CRA team performance including implementation of development and performance improvement plans
What youll bring to the role:
Essential:
Leadership skills
Excellent coaching capability to best support CRA in driving right mindset and behavior
Thorough understanding of the international aspects of drug development process including expert knowledge of international standards (GCP/ICH) health authorities (FDA/EMA) local/National Health Authorities regulations riskbased monitoring and Novartis standards
Good communication skills ability to influence others & relationship management
Minimum 7 years experience in clinical research planning/executing and/or monitoring clinical trials as well as experience in project management and evidence of team leadership capabilities
Ability to travel domestically for on site oversight visits
Desirable:
Fluent in both written and spoken English & French
Skills Desired
bilingual (french/english) Change Management Clinical Research Clinical Trials Clinical Trials Monitoring Coaching Collaboration Communication CO Monitoring Data Analysis Decision Making Skills Drug Development drug development process English Language FDA Regulations French Language General Management Health Sciences ICH GCP Guidelines Leadership Monitoring Services Project Management Team Leadership Waterfall ModelRequired Experience:
Manager
Employment Type
Full-Time
