Associate Director Study Data Manager

Associate Director Study Data Manager

Step into a role where your judgment and leadership directly shape the speed, integrity, and readiness of pivotal trials.

Introduction to role

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.

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

Accountabilities

• 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.
• 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.
• 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.
• Contribute to corporate, therapeutic, and program‑level data capture standards; champion adoption to improve consistency and downstream analysis readiness.
• Lead DM inspection preparation at the study level, provide input into regulatory inspections and audits, and ensure compliance with Trial Master File requirements.
• 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.
• Maintain awareness of internal and external trends; participate in change initiatives and continuous improvement activities to evolve DM operating models and ways of working.
• Oversee vendor timelines and milestone deliverables; manage budget adherence and performance metrics to enable predictable, high‑quality delivery.
• 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.
• Experience with 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.

Benefits & Compensation

Annual base salary ranges from $131,520.80 to $172,621.05 CAD. In addition, the position offers a short‑term incentive bonus opportunity, eligibility to participate in an equity‑based long‑term incentive program (for salaried roles), and retirement contribution benefits for hourly roles. Permanent positions include a competitive Flex Benefits & Retirement Savings Program, 4 weeks of paid vacation, and annual personal days.

Fixed‑term contract/temporary positions (excluding students) are offered a contract benefits program.

AstraZeneca is committed to providing fair and equitable compensation opportunities to all colleagues.

This advertisement relates to a current vacancy.

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