Position Type: Full-Time, 12 Month Contract

Location: Quebec

Career Level: D

Are you motivated by building positive collaborations with partners? Do you love leading and advising on clinical studies?  As a member of the Clinical Site Management and the local study teams, you represent Clinical Site Monitoring and provide input during planning and document review, and will ensure data is clean at file stage of clinical trials.  You are the subject lead on site management processes and are responsible for positively managing clinical sites from site selection to site closure.

ABOUT ASTRAZENECA

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.

AstraZeneca In Canada

Headquartered in Mississauga, Ontario, we’ve been recognized as one of Greater Toronto Area’s Top Employers for 7 straight years. Our work environment cultivates knowledge-sharing, decision-making, and entrepreneurial thinking. Our employees have the opportunity to work across teams, functions, and even the globe. With a commitment to sustainability, we’re working towards making our head office and internal and external meetings green.

BUSINESS AREA

Join the team dedicated to Oncology, with an ambition to eliminate cancer as a cause of death. It’s our big vision that unites and inspires us.

A place built on courage, curiosity and collaboration – we make bold decisions driven by patient outcomes. Empowered to lead at every level, free to ask questions and take smart risks that write the next chapter for our pipeline and Oncology team.

What you’ll do

Your responsibilities will include:

• Build positive relationships with site partners through site selection, patient recruitment, training on AZ protocols, SOPs, clinical guidelines, and data collection; site visits and site closures
• Influence and facilitate site documentation collection for timely initiation of sites and to maximize the recruitment period to deliver clinical studies to plan
• Lead strategies for patient recruitment to met recruitment targets
• Share knowledge and coach new CRA's on technical skills and positively impact the development of the regional territory including progressing valued relationships with investigators and sharing this information within AZ to enhance customer experiences
• Ensure accuracy of patient data by verifying source data, ensuring timely reporting of Serious Adverse Event's, handling of study-drug supplies and overall management of the Investigator Study File (ISF); completes audit reports and ensures follow-up issues are completed by deadlines
• Actively identifies study-related issues and elevates issues as appropriate.
• Collect Customer Insights from investigative sites with documentation in appropriate systems
• Report site and patient level information accurately in AstraZeneca clinical trial management systems within specified timelines
• 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)
• Identify or follow-up on potential new sites and develop inexperienced sites within territory for future studies by collaborating with Commercial representatives in the territory
• Participate in customer planning initiatives for key customers in territory
• Assist with planning and delivery of Regional meetings
• Responsible for collecting and reporting Adverse Events in accordance with AstraZeneca policies and procedures

As Local Study Team Representative, you will:

• Build and maintain the study summary sheet with input from Local Study Team colleagues
• Attend team meetings, presenting feedback from the monitoring team on study specific issues for Local Study Team consideration, and disseminating information to CRA’s via email updates and teleconferences (as needed); you may attend and present at the Investigator Meeting
• Communicate issues and risks affecting study deliverables to Manager, Clinical Research Associate (M,CRA)/Local Study Manager (LSM) for communication to the global team
• Collaborate with Manager - CRA, LSM to identify potential risks to Data Base Lock, review unresolved/outlier data, Source Data Verification and Data Query reports, provide status update and follow-up requirements to assigned CRA and Manager – CRA including advising on the risk management plan

Your qualifications include:

• University degree or College diploma (professional accreditation) in Health Sciences field
• Minimum 2 years’ experience in clinical research role
• Previous oncology experience required
• Ability to work independently and handle fluctuating workloads
• Professional collaboration skills, adept at influencing others and excellent communication skills
• Detail savvy with excellent critical thinking skills
• Possess a valid driver's license
• Ability to travel overnight, work from home and available to work flexible hours

Why AstraZeneca?

This is the place to make an important impact – on patients’ lives and your personal growth. It’s both rewarding and inspiring, and it’s what keeps us motivated every day.

Great People want to Work with us! Find out why:

• GTAA Top Employer Award for 7 years:https://reviews.canadastop100.com/top-employer-astrazeneca-canada
• Best Workplace Culture Award at the 2018 Canadian HR Awards:https://www.linkedin.com/pulse/thriving-best-workplace-culture-gena-restivo/
• Browse AstraZeneca's YouTube channel to find out more about us:https://www.youtube.com/user/astrazeneca

Are you interested in working at AZ, apply today!

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.