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Associate Director, Study Data Manager

Location Mississauga, Ontario, Canada Job ID R-146489 Date posted 21/09/2022

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.

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:

Our data management team supports our global clinical studies from study start-up, to study close-out. The Associate Director, Study Data Manager (ADSDM) works with various study leaders building positive relationships across cross-functional teams to bring data integrity and ensure data quality of AstraZeneca's global late phase studies.

As a core member of the study team, the ADSDM is responsible for the overall quality and integrity of the clinical database, working positively with global study teams to ensure that AstraZeneca’s Clinical Data is collected, managed, documented and reported clearly, accurately, and securely based on the study’s protocol and to the highest scientific industry standards.

Accountabilities:

  • 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 Clinical 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.

  • May provide input to the selection and use of software systems, devices and vendors.

  • 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.

  • Maintain an awareness of the external and internal models in order to participate in change initiatives and continuous improvement activities related to CDM operating models.

  • Demonstrates willingness to take on ad hoc activities consistent with current or experience in support of CDM.

  • Mentoring junior Clinical Data management colleagues

Essentials:

  • Education: Minimum of a BSc in life sciences or related subject, pharmacy nursing or equivalent degree

  • Strong Data Management experience in the Biotech/Pharma/CRO industry

  • Demonstrated current understanding of GCP and regulatory requirements as they relate to data management systems and activities

  • Demonstrated current understanding of Good Clinical Data Management Practices (GCDMP)

  • 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

  • Strong communication and interpersonal skills

  • Ability to work independently without close supervision

  • Excellent written and verbal communication skills

  • Effective problem and conflict solving skills

  • Ability to work in a global team environment

  • High attention to detail and accuracy

Desirable:

  • Certified Clinical Data Manager (CCDM) via the Society of Clinical Data Management

  • Demonstrated knowledge of clinical and pharmaceutical drug development process

  • State of the art understanding of database structures, data standards (CDISC) and practices as they apply to CRF design, database development, data handling and reporting

  • Knowledge of SQL, 4GL, VBA or R software

  • Demonstrated understanding of clinical data system design / development / validation and system interoperability.

  • Excellent understanding and demonstration of the AZ values and behaviors

  • Demonstrated professionalism, diplomacy, mutual respect and ability to manage and value diversity and cultural differences while promoting productivity through encouragement

  • Excellent organizational and analytical skills

  • Demonstrated ability to work effectively with external partners

  • Ability to interact effectively with all levels of management

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

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

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 AZCHumanResources@astrazeneca.com.

10001263 E CDDM

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Glassdoor logo Rated four stars on Glassdoor

Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.