• Job Description

  Req#: R-201687

  At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe.

  Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.

  Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

  Responsible for coordination of the Clinical Data Management (CDM) deliverables on assigned clinical studies and may be an expert on CDM processes, standards and technology. May act as a Core member of Global Study Team (GST) and may lead studies with less complexities. Collaborates with DM vendors and liaise with a variety of departments on a local and/or global level to ensure each study is run in accordance to the specifics of the model. Maintains Business Continuity for CDM processes and standards including integrity of the clinical database for the relevant studies. May work under direction of an experienced Principal Project Data Manager.

  Roles and responsibilities

  • Coordinate the Clinical Data management deliverables on assigned studies depending on the relevant model and DM Vendor. Takes accountability and serves as the first line of contact at the study level.
  • Demonstrates leadership and operational knowledge in the planning and delivery of CDM deliverables at a study level potentially under mentorship from a Principle Project Data Manager.
  • Communicates and collaborates effectively with all study level team members. Primary point of contact for DM vendor and provides guidance and supervision to Lead Data Manager/DM Team Lead working on the study (CRO or in-house).
  • Oversight of the day to day operational aspects of CDM for assigned studies; 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 for assigned studies.
  • Responsible for compliance to Trial Master File requirements relating to DM Vendor
  • Support Senior Leaders to oversee CDM Vendor performance, depending on relevant model. Review, assess and manage DM Vendor delivery against KPIs, budget and overall performance. Oversees vendor timelines and milestone deliverables for the assigned studies. 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 capturing for assigned studies.
  • Demonstrates willingness to take on ad hoc activities consistent with current or experience in support of CDM.
  • Mentoring junior Clinical Data management colleagues
  • Performs any CDM related ad-hoc requests from Line Manager or superior

  Education, Qualifications, Skills and Experience

  • University or college degree in the life sciences or related subject, pharmacy, nursing or equivalent relevant degree
  • 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)
  • Demonstrate understanding and experience in query management process and reconciliation activities
  • Ability to work flexibly on simultaneous projects and proactively manage time to meet own deadlines.
  • Excellent written and verbal communication skills
  • Ability to work in a global team environment
  • Excellent organizational and analytical skills and high attention to detail
  • Demonstrated knowledge of clinical and pharmaceutical drug development process
  • Demonstrated understanding of clinical data system design / development / validation and system interoperability.
  • Demonstrated ability to work effectively with external partners
  • Understanding of database structures, programming languages, data standards (CDISC) and practices as they apply to CRF design, database development, data handling and reporting
  • Knowledge of SQL or SAS software

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

  • GTAA Top Employer Award for 10 years
  • Top 100 Employers Award
  • Canada’s Most Admired Corporate Culture
  • Learn more about working with us in Canada
  • View our YouTube channel

  Are you interested in working at AZ, apply today!

  AstraZeneca is an equal opportunity employer that is 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 .

  Date Posted

  06-Jun-2024

  Closing Date

  22-Jul-2024

  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.

• About the company

  AstraZeneca PLC is a British-Swedish multinational pharmaceutical and biopharmaceutical company with its global headquarters in Cambridge, England.

Notice