Associate Director, Project Data Manager

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:

As an Associate Director Project Data Manager, you will oversee the Clinical Data Management (CDM) delivery of high-quality data through external partners or internally run studies for one or more assigned projects or indications. You may also act as an expert on CDM projects and technology outside of CDM program support. Staying abreast of trends and changes in external CDM approaches, you will serve as a subject matter expert in process development and improvement. Additionally, you may lead a team or provide training and coaching to junior colleagues within CDM.

Accountabilities:

• Provide CDM leadership for assigned projects, indications, and/or studies, taking global accountability and serving as the second line of contact at the project level.
• Demonstrate leadership and operational expertise in strategic planning and delivery of CDM deliverables at the project level, including management and oversight of vendor contracts, resourcing, budget management, and vendor performance.
• Communicate and negotiate effectively with all other project-level team members, acting as the primary point of contact for CDM at the Global Program Team (GPT) level.
• Apply a business understanding of the compound profile to ensure consistent CDM processes and documentation across assigned projects.
• Oversee and provide expertise to external service providers or in-house teams to deliver quality data in compliance with study model procedures and standards.
• Manage proactive risk management and issue resolution/escalation related to CDM improvement or technology.
• Suggest improvements to AZ Standards, CDM processes, and technologies, potentially acting as a Subject Matter Expert in these areas.
• Develop an understanding of CDASH and SDTM or other recognized industry standards to ensure consistency of program-level standards.
• Specialize in TA-specific data capture and standards, conducting lessons learned and disseminating them across the organization.
• Support strategic and operational aspects of Data Management at the project level.
• Mentor Clinical Data Management colleagues and stakeholders on operational processes used in studies and projects.
• Represent Clinical Data Management at cross-functional forums and meetings, providing timely feedback to partners.
• Understand health authority requirements and provide input into CDM-related activities associated with regulatory inspections/audits.
• Lead project-level activities consistent with current experience in support of study delivery, potentially acting as Study Data Manager for assigned studies.
• Perform any CDM-related ad-hoc requests from the Line Manager and support portfolio oversight.

Essential Skills/Experience:

• University or college degree in life sciences or related subject, pharmacy, nursing, or a relevant degree.
• Ability to successfully manage simultaneous trials and meet deadlines.
• Significant Clinical Data Management experience, preferably from both 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.
• Strong focus on detail and a analytical approach.
• Comprehensive knowledge of database structures and capturing/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 with CRO and vendor management.

Desirable Skills/Experience:

• Experience as a lead of a large Phase III trial or multiple smaller trials.
• Knowledge of SQL, 4GL, VBA, or R software.
• Experience managing teams.
• Experience with Regulatory Inspections.
• Project Management training.

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
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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 emailingAZCHumanResources@astrazeneca.com.

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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.