Associate Director Study Data Manager

Job Title: Associate Director Study Data Manager

Career Level - E

Introduction to Role:
Are you ready to take the next step in your career? We are seeking an Associate Director Study Data Manager to join our Oncology R&D team. This role is 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 is an exciting opportunity to learn and grow from the brightest minds in the industry.

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, ensuring adherence to AZ DM standards and processes for data quality, and providing input into DM related activities associated with regulatory inspections/audits. You will also mentor junior Clinical Data Management colleagues.

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 minimum 12 years of 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 on a mission to eliminate cancer as a cause of death. We are a science-based, leading Oncology enterprise united in our vision. With one of the broadest and deepest Oncology pipelines in the industry, we are at the forefront of applying science to studies and using innovative approaches to create new possibilities. We foster a mindset of courage, where everyone is empowered to step up, innovate and work at pace. Our commitment to patients and pioneering spirit are truly embedded and it's what makes our pipeline unique. We believe in growing together and providing a place where everyone can have a voice.

Ready to make a difference? Apply today and join our mission to change lives!