OverviewAstraZeneca Clinical Site Monitor – Montreal 12 Month Contract Temporary in Montréal, QC
Branch Montréal QC CA
Clinical Site Monitor – Montreal 12 Month Contract
AstraZeneca Canada is not just ‘another’ pharmaceutical company. Represent Clinical Site Monitoring on study teams from start to closure including the review of…
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AstraZeneca Canada is not just ‘another’ pharmaceutical company. We are an organization that cares about people and their health, and we know a healthier world cannot come from drugs alone. That’s why we’ve created a culture that is unlike anything you have experienced before. People are simply at the heart of everything we do – in all of our business strategies and activities – and that is what makes us successful and will continue to drive our business forward. Beyond our effective medicines, we use our courage, creativity and collaboration to create innovative programs that support health education, find better ways to manage disease, and increase healthcare access. When we talk to one another to solve problems, and work with each other to reach common goals, an incredible thing happens – together we move beyond traditional roles to really improve the future of healthcare. Together we create a truly unique place to work – one where we simply love what we do and have fun doing it.
Position Title: Clinical Site Monitor
Position Type: 12 Month Contract
Career Level: D
As a member of Clinical Site Management and the local study teams, the Clinical Site Monitor (CSM) represents Clinical Site Monitoring on study teams and provides input during the planning, document review, and is responsible for clean file stage of clinical trials. They are the subject matter experts in site management processes and are responsible for managing clinical sites from site selection to site closure. This includes accountability for site-specific patient recruitment and training of site staff with respect to protocol, systems, GCP and ICH guidelines to ensure high quality data. The CSM acts as the primary contact for clinical sites and conducts all site visits according to AstraZeneca’ Standard Operating Procedures (SOPs). The CSM is responsible for technical skills transfer for new CSMs and the development of the regional territory including maintenance of value-added relationships with their investigators and sharing this information within AZ to enhance customer experiences.
Conduct site visits from site selection to site closure.
Facilitate site documentation collection to ensure timely initiation of sites and to maximize recruitment period in support of delivering clinical studies to plan.
Ensure accuracy of patient data by performing source data verification of paper and/or electronic Case Report Forms, accurate and timely reporting of Serious Adverse Event’s, proper handling of study-drug supplies at study sites and overall management of the Investigator Study File (ISF). Contribute to the completion of audit reports and ensure follow-up issues are completed within specified timelines.
Establish patient recruitment targets and ensure they are met for each site. Propose and implement site specific recruitment strategies.
Provide continuous training, support (study-related, systems-related and Good Clinical Practice) and direction to clinical trial site staff to ensure study data is collected in accordance with source documents, study protocol, AZ procedural documents and International Conference on Harmonisation (
)/Good Clinical Practice guidelines (GCP).
Proactively identifies study-related issues and escalates as appropriate.
Collect Customer Insight from investigative sites with documentation in appropriate systems.
Report site and patient level information accurately in AstraZeneca clinical trial management systems within specified timelines.
Participate as a member of local study teams, to contribute to the delivery of the study according to plan. Act as a conduit between site and Local Study Team for site related issues.
Ensure optimal management of time and expenses in support of the business
Ensure compliance with AstraZeneca’s Code of Conduct and company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment)
Develop personally and professionally in support of organizational effectiveness.
Identify or follow-up on potential new sites and develop inexperienced sites within territory for future studies. Liaison with Commercial representatives in the territory.
Participate in customer planning initiatives for key customers in their territory.
Transfer of technical skills for new Clinical Site Monitors for monitoring processes, best practices for Web Based Data Capture, Secure Document Exchange and other monitoring related systems by conducting monitor accompanied site visits.
Provide site management assistance to other members of Clinical Site Monitoring, as needed for study specific training, high recruiting centres, interim and clean file deadlines.
Assist with planning and delivery of Regional meetings
As Local Study Team Representative
Represent Clinical Site Monitoring on study teams from start to closure including the review of study level documents such as draft protocols, Case Report Form’s (paper or electronic), Case Report Form review manuals, Source Data Verification plan. Develop monitoring tools.
Active participation in the planning and conduct of monitor training meeting to ensure Clinical Site Monitor training needs for the study are met.
Responsible for training new Clinical Site Monitors transitioning onto the study on protocol and study specific processes.
Work with Enablement to request study related system access for new Clinical Site Monitors and confirms Clinical Site Monitors ability to access systems.
Responsible for development and maintenance of study summary sheet with input from Local Study Team Subject Matter Experts.
Attends Local Study Team meetings, solicits feedback from monitoring team on study specific issues for Local Study Team consideration, and disseminates information to Clinical Site Monitors via email updates and teleconferences (as needed); may attend and present at the Investigator Meeting.
Communicate issues and risks affecting study deliverables to Manager, Clinical Site Monitoring (M,CSM)/Study Delivery Leader (SDL) for escalation to global team.
Collaborate and communicate with local and global study teams in the development of processes and expectations for Interim Analysis, Database locks, close-out visit procedures and other study related deliverables
Proactively works with Manager – Clinical Site Monitoring, Study Delivery Lead to identify potential risks to Data Base Lock, review outstanding data, Source Data Verification and Data Query reports, provide status update and follow-up requirements to assigned Clinical Site Monitors and Manager – Clinical Site Monitors.
Provide input into risk management plan.
Regular updates to clinical site monitors on study status (challenges, issues, successes, changes in resourcing)
University degree or College diploma (professional accreditation) in Health Sciences field
Minimum 3 years experience as a Clinical Site Monitor
Oncology experience is an asset
Bilingual (French & English)
Ability to work independently and manage fluctuating workloads
Ability to comprehend and understand the content of study protocols
Strong interpersonal skills and excellent communication skills
Strong attention to detail
Excellent problem solving and influencing skills
Computer skills: proficiency in Microsoft Office suite of products and internet applications
Must have valid driver’s license
Overnight travel will be required
Ability to work from home
Ability to work flexible hours
Extensive use of computer
A combination of education and work experience will be considered
Only candidates who meet the minimum requirements as outlined above, will be interviewed. Internal candidates who are interested in this position must inform their manager before they apply.
Aug 17, 2015, 9:06:20 AM
Aug 31, 2015, 10:59:00 PM
Employment Type: Temporary
Location: Montreal, QC, CA
Posted on: 2015-08-17