Job Description

About AstraZeneca:

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.

AstraZeneca Canada:

Headquartered in Mississauga, Ontario, we've been recognized as one of Greater Toronto Area's Top Employers for 8 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.

Accountabilities:

Provides CDM leadership for assigned projects, indications and/or studies dependent on size and scale of the project. Takes global accountability and serves as the second line of contact at the project level.

Demonstrates leadership and operational expertise in the strategic planning and delivery of CDM deliverables at project level. Management and oversight of vendor contracts, resourcing and budget management and oversight of vendor performance for assigned projects and studies.

Communicates and negotiates effectively with all other project level team members. Primary point of contact for Clinical Data Management (CDM) at the Global Program Team (GPT) level.

Demonstrates a business understanding of the compound profile to identify and assist in successful application of consistent CDM processes and documentation across assigned projects, (i.e. ensuring consistency across data quality plans.)

Provide oversight and expertise of external service providers or in-house teams to deliver quality data with compliance to study model procedures and standards; give guidance on AZ standards, processes, systems and expectations to external partners, internal partners and third-party vendors.

Responsible for proactive risk management and issue resolution/escalation connected to Clinical Data Management improvement or technology.

Develops an understanding of CDASH and SDTM or other recognized industry standards and impact to programming team to ensure consistency of program level standards.

Specialist in TA specific data capture and standards, conducts lessons learned and disseminate across the organization as appropriate

Provides data management expertise in supporting strategic and operational aspects of Data Management on project level.

May act as a team leaders or mentor Clinical Data Management colleagues and any stakeholder with operational processes used in studies and projects.

Represents Clinical Data Management at cross functional forums, meetings and provides timely feedback to partners.

Understands health authority requirements and provide input into the Clinical Data Management related activities associated with regulatory inspections/audits and liaison with Clinical Quality Assurance.

Demonstrates willingness to take on and lead any project level activity consistent with current or experience in support of study delivery.

Performs any CDM related ad-hoc requests from Line Manager or other senior managers.

Essentials:

• University or college degree in the life sciences or related subject, pharmacy, nursing or equivalent relevant degree.
• Ability to successfully manage simultaneous trials and meet deadlines.
• Significant Clinical Data Management experience, preferable both from CRO and Pharma industry in more than one therapeutic area.
• Excellent understanding of clinical trials methodology, GCP, GDMP and medical terminology.
• Comprehensive knowledge of clinical standards, e.g. SDTM or CDASH.
• High attention to detail and a strong analytical mind-set.
• Demonstrates a comprehensive knowledge of database structures and of capturing and storing clinical information as they apply to CRF design, database development, data handling and reporting.
• Excellent interpersonal skills and proven ability to operate effectively in a global environment
• Good written and verbal communication skills, negotiation, collaboration, conflict management and interpersonal skills.
• Cultural awareness.
• Experience of CRO and vendor management.

Desirables:

• Experience as a lead of a large Phase III trial or multiple smaller trials;
• Knowledge of SQL, 4GL, VBA or R software
• Experience of managing teams.

Location: Head office based position based in Mississauga, Ontario (Canada)

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

GTAA Top Employer Award for 8 years:

Best Workplace Culture Award at the 2018 Canadian HR Awards:

Browse AstraZeneca's Oncology YouTube channel:

Are you interested in working at AZ, apply today!

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 a crucial 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 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 .

Date Posted 12-Sep-2022

Closing Date 19-Sep-2022

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.