Senior Clinical Data Manager, Oncology
AstraZeneca is a global, innovation-driven Biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious disease. But we’re more than one of the world’s leading pharmaceutical companies.
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.
Headquartered in Mississauga, Ontario, we’ve been recognized as one of Greater Toronto Area’s Top Employers for 7 straight years. Our collaborative work environment fosters 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 a meaningful impact where society needs it — health. We know the health of people, the planet and our business are interconnected, each impacting the others.
Our dynamic culture truly sets us apart. We support our people every day, focusing on three priorities: employee growth & development, health & wellbeing, and cultivating a vibrant, engaged and energized workplace. Through practical tools, resources, inspiring learning opportunities, and health and wellness support, we are helping our people thrive at work and beyond.
Our Oncology Research and Development Team:
Oncology is driven by speed. Here you will be backed by leadership and empowered at every level to prioritize and make bold moves. Our pioneering approach is identifying and treating patients earlier, focusing on early-stage cancer trials and listening and evolving based on their needs.
Join a dedicated Oncology team that’s growing fast and building a strong track record of success.
What you’ll do:
Coordinate deliverables on assigned projects depending on the relevant model and Data Management (DM) Vendor. Serves as the first line of contact at the project level.
Demonstrate leadership and operational knowledge in the planning and delivery of CDM deliverables at a project level under mentorship from a Principle Clinical data manager.
Responsible to identify risks and collaborate with the DM Vendor to mitigate the risk.
Understand therapeutic area, indication or program specific data capture standards and AZ standards.
Provide input into CDM related activities associated with regulatory inspections/audits.
Responsible for compliance to Trial Master File requirements relating to DM Vendor
Support Senior Leaders to coordinate CDM Vendor performance, depending on relevant model.
Review, assess and manage DM Vendor delivery against KPIs, budget and overall performance.
Coordinate vendor timelines and milestone deliverables for the assigned projects.
Ensures DM Vendor billing is accurate and gives recommendations for payment of invoices.
Drive adherence to AZ CDM standards and processes for data quality and consistency of data collecting.
Mentoring Clinical Data Managers or junior staff
Essentials for the role:
University or college degree in the life sciences or related subject, pharmacy, nursing or equivalent
Ability to successfully lead simultaneous trials and meet deadlines while working with external partners
Solid knowledge of Clinical Data Management and experience in the Biotech/Pharma/CRO industry
Demonstrated current understanding of Good Clinical Data Management Practices (GCDMP) and relevant regulatory requirements
Demonstrated experience of clinical databases, different clinical data management systems and electronic data capture (EDC)
Experience with query management process and reconciliation activities
Good communication and interpersonal skills including effective problem solving
Ability to work independently in a global team environment
Excellent written and verbal communication skills
Location: Head Office based position – Mississauga
This is the place to make a meaningful 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
Browse AstraZeneca's YouTube channel to find out more about us: https://www.youtube.com/user/astrazeneca
AstraZeneca is committed to taking every reasonable precaution to protect employees, our customers and the healthcare systems in the communities in which we serve. In an effort to protect the wellbeing of our employees and customers, full COVID-19 vaccination is an essential requirement of all positions at AstraZeneca. As such, all offers of employment will be conditional upon either (i) proof of full COVID-19 vaccination or (ii) proof of need for accommodation under relevant human rights legislation, and AstraZeneca’s determination that the requested accommodation can be provided without undue hardship.You will be required to submit proof of full vaccination or proof of need for accommodation during our background screening process.
AstraZeneca is an equal opportunity employer, committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing AZCHumanResources@astrazeneca.com.
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 authorisation and employment eligibility verification requirements.