Associate Director Study Data Manager

Are you ready to coordinate Clinical Data Management (CDM) deliverables on pivotal clinical studies? As an Associate Director Study Data Manager, you'll be at the forefront of ensuring data quality and integrity, while maintaining business continuity for CDM processes and standards. You'll be a key member of the Global Study Team (GST), serving as the main point of contact for the Data Management (DM) vendor. Your expertise in CDM processes, standards, and technology will be crucial in driving success across assigned studies.

Accountabilities:

• Take charge of coordinating CDM deliverables on assigned studies, acting as the first line of contact at the study level. 

• Exhibit strong leadership and project management skills in planning and delivering CDM outcomes, potentially under mentorship from a Project Data Manager.

• Communicate and collaborate effectively with study team members, guiding and supervising Lead Data Manager/DM Team Lead.

• Provide oversight and expertise in day-to-day DM operations, identifying risks and collaborating with DM Vendor to mitigate them.

• Contribute to corporate, therapeutic/indication, and program-specific data capture standards.

• Drive adherence to AZ DM standards for data quality and consistency.

• Lead DM inspection preparation and provide input into regulatory inspections/audits.

• Influence the selection and use of software systems, devices, and vendors.

• Ensure compliance with Trial Master File requirements.

• Support Senior Leaders in overseeing DM Vendor performance, managing delivery against KPIs, budget, and overall performance.

• Stay aware of external and internal trends to participate in change initiatives and continuous improvement activities.

• Mentor junior Clinical Data Management colleagues.

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.

• Current understanding of Good Clinical Data Management Practices (GCDMP) and relevant regulatory requirements.

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

• Ability to work effectively with external partners.

• Experience with clinical databases, different clinical data management systems, and electronic data capture (EDC).

• 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:

• Knowledge of clinical and pharmaceutical drug development process.

• Understanding of database structures, programming languages, data standards (CDISC) as they apply to CRF design, database development, data handling, and reporting.

• Understanding of clinical data system design/development/validation and system interoperability.

• Professionalism, diplomacy, mutual respect, ability to manage/value diversity and cultural differences.

• Experience within Sponsor organization and Regulatory inspections.

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.