At AstraZeneca, we are united by a common purpose – to push the boundaries of science to deliver life-changing medicines. This purpose underpins everything we do; our work helps to make hearts healthier, to help people breathe easier, and to help more people survive cancer. Every single day, we make a difference by delivering potentially life-changing medicines to millions of people worldwide and by leading breakthrough science that promises to transform the treatment of disease.

Position Title: Senior Clinical Data Manager

Position Type: Regular, Full-time

Location: Head Office - Mississauga

Responsibilities

• 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.
• Demonstrates 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.
• Understands 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.
• Coordinates 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

Qualifications

• 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
• Excellent organizational and analytical skills and high attention to detail

Next steps – Apply today

Do you have what it takes? To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience. If you know someone who would be a great fit, please share this posting with them!

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Great People want to Work with us! Here's why:

GTAA Top Employer Award for 5 years: https://content.eluta.ca/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/

Total Rewards for employees: https://www.astrazeneca.ca/en/working-at-az-canada/Total-Rewards.html

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.