Associate Director Study Data Manager

Associate Director Study Data Manager

Introduction to role:
Are you ready to lead clinical data delivery that accelerates breakthrough medicines for patients with cancer? Step into a role where your judgment and leadership directly shape the speed, integrity, and readiness of pivotal trials.

You will be the study-level data authority, aligning vendors, standards, and systems to deliver complete, inspection-ready datasets that inform go/no-go decisions and regulatory submissions. Working at the heart of a fast-moving portfolio, you will influence how data are captured, cleaned, and curated across multiple indications, ensuring quality that stands up to scrutiny. How will you apply your vendor leadership and data standards expertise to bring precision to every decision?

This is a hybrid position, with a requirement to work three days in the office.

Accountabilities:

• Study-Level Data Leadership: Take end-to-end accountability for Clinical Data Management deliverables on assigned studies, serving as the first line of contact and orchestrating plans, timelines, and quality outcomes.

• Vendor Oversight and Performance: Act as primary point of contact for the DM vendor; guide and supervise the Lead Data Manager/DM Team Lead (CRO or in-house) to meet scope, timelines, and quality. Review delivery against KPIs, oversee billing accuracy, and recommend invoice payments.

• Operational Excellence: Provide expert oversight of day-to-day data operations, ensuring proactive issue identification, robust mitigation with vendors, and timely escalation. Drive adherence to standards and processes to achieve consistent, high-quality data capture.

• Standards and Governance: Contribute to corporate, therapeutic, and program-level data capture standards; champion adoption to improve consistency and downstream analysis readiness.

• Inspection Readiness: Lead DM inspection preparation at the study level, provide input into regulatory inspections and audits, and ensure compliance with Trial Master File requirements.

• Technology and Systems: Provide input to the selection and use of software systems, devices, and vendors as needed; bring practical insight to database build, EDC configuration, and interoperability considerations.

• Risk and Change Leadership: Maintain awareness of internal and external trends; participate in change initiatives and continuous improvement activities to evolve DM operating models and ways of working.

• Financial and Timeline Stewardship: Oversee vendor timelines and milestone deliverables; manage budget adherence and performance metrics to enable predictable, high-quality delivery.

• People Development: Mentor junior Clinical Data Management colleagues, building capability and strengthening delivery across studies.

Essential Skills/Experience:
• University or college degree in the 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.

Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. The annual base salary for this position ranges from $131,520 CAD to $172,621 CAD. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles).

Why AstraZeneca:
Here, science moves at pace and data are the connective tissue from first-in-human to registration. You will work on a bold, well-funded pipeline aiming to deliver multiple new medicines in the near term, partnering with clinicians, statisticians, and technologists in an environment where unexpected teams gather in the same room to unleash bold thinking. We unite curiosity with discipline, valuing kindness alongside ambition, so you can take smart risks, learn fast, and see your decisions ripple from clean case report forms to life-changing treatments for patients. Your leadership will elevate how we capture, verify, and present evidence across some of the most challenging cancers—turning meticulous data stewardship into tangible patient impact.

Call to Action:
If you are ready to own study-level data outcomes and turn flawless execution into faster decisions for patients, step forward and shape what happens next!

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AstraZeneca is committed to providing fair and equitable compensation opportunities to all colleagues. Our compensation policies and practices have been designed to allow colleagues to progress through the salary range over time as they progress in their role. The range provided in this posting represents an offer pay range used in a majority of situations. The base pay offered will vary depending on multiple individualized factors, including the candidate's skills and experience, job-related knowledge, and other specific business and organizational needs.  In some cases, offers outside the range may also be considered to address unique circumstances.

In addition, our permanent positions offer an annual Variable Pay Bonus/Short Term Incentive opportunity as well as eligibility to participate in our equity-based long-term incentive program (if applicable to role).  Benefits offered for permanent roles include a competitive Flex Benefits & Retirement Savings Program, 4 weeks’ paid vacation, and annual Personal Days. Fixed Term Contract/Temporary positions (excluding students) are offered a Contract Benefits Program.

We are using AI as part of the recruitment process.

This advertisement relates to a current vacancy.