Associate Director Study Data Manager

Job Title: Associate Director Study Data Manager 
Location: Mississauga, ON 

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.  

Introduction to Role: 

Join our Biopharmaceuticals R&D team as an Associate Director Study Data Manager, where you will be responsible for coordinating the Clinical Data Management (CDM) deliverables on assigned clinical studies. As a member of the Global Study Team (GST), you will be the main point of contact for the Data Management (DM) vendor and ensure CDM deliverables follow standards and meet data quality. This role offers the opportunity to maintain business continuity for CDM processes and standards, including the integrity of the clinical database for relevant studies.  

Accountabilities: 

As an Associate Director Study Data Manager, you will coordinate the Clinical Data Management deliverables on assigned studies, serve as the first line of contact at the study level, and demonstrate strong leadership and project management skills. You will be responsible for overseeing the day-to-day operational aspects of DM for assigned studies, identifying risks, and collaborating with the DM Vendor to mitigate these risks. You will also provide input into DM related activities associated with regulatory inspections/audits for assigned studies and oversee DM Vendor performance. 

Essential Skills/Experience: 

• University or college degree in life sciences or related subject, pharmacy, nursing or equivalent relevant degree 

• 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 

• Strong Project Management and Lead DM experience; Exhibits expertise in metrics analysis and reporting methodologies 

• Demonstrated ability to work effectively with external partners 

• 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 

• Good communication and interpersonal skills including effective problem solving 

• Ability to work independently without close supervision 

• Excellent written and verbal communication skills 

• Ability to work in a global team environment 

• Excellent organizational and analytical skills, sound decision making skills, and high attention to detail 

Desirable Skills/Experience: 

• Demonstrated knowledge of clinical and pharmaceutical drug development process 

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

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

• Demonstrates professionalism, diplomacy, mutual respect and the ability to manage/value diversity and cultural differences and promote productivity through encouragement 

• Experience within Sponsor organization and Regulatory inspections 

At AstraZeneca, we are driven by our desire to understand and reveal new insights. We follow the science to explore and innovate, working towards treating, preventing, modifying and even curing some of the world's most complex diseases. We are committed to making a difference by fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs. We offer an inclusive environment where we work seamlessly as one, uniting the best from academia, biotechs, and the industry. If your passion is science and you want to be part of a team that makes a bigger impact on patients' lives, then there's no better place to be. 

Ready to embrace new and varied opportunities to develop and learn? Apply now and join us in pushing the boundaries of science to deliver life-changing medicines! 

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

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.