Associate Director Study Data Manager

Job Title: Associate Director Study Data Manager

Introduction to role

Are you ready to take on a high exposure role that coordinates Clinical Data Management (CDM) deliverables for clinical studies? As an Associate Director Study Data Manager, you'll be the expert on CDM processes, standards, and technology, ensuring data quality and maintaining business continuity. You'll be the main point of contact for the Data Management vendor and a vital member of the Global Study Team. This role offers the opportunity to make a significant impact in the field of clinical data management.

Accountabilities

In this dynamic position, you'll coordinate CDM deliverables on assigned studies, taking accountability and serving as the first line of contact at the study level. Your responsibilities will include:

• Demonstrating strong leadership and project management skills in planning and delivering CDM deliverables.
• Communicating and collaborating effectively with study team members and providing guidance to the DM vendor.
• Overseeing day-to-day operational aspects of DM, identifying risks, and collaborating with vendors to mitigate them.
• Contributing to corporate, therapeutic/indication, and program-specific data capture standards.
• Driving adherence to AZ DM standards for data quality and consistency.
• Providing input into DM activities related to regulatory inspections/audits.
• Supporting Senior Leaders in overseeing DM Vendor performance and managing delivery against KPIs and budgets.
• Participating in change initiatives and continuous improvement activities related to DM operating models.
• Demonstrating willingness to take on ad hoc activities.

Essential Skills/Experience

• University or college degree in life sciences or related subject, pharmacy, nursing or equivalent relevant degree or equivalent experience.
• 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.

When we put unexpected teams in the same room, we ignite bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, you'll play an essential role in helping patients who need it most. Here, your Biometrics expertise will be valued as you work across all Therapy Areas, shaping end results and embracing global opportunities. Our supportive yet ambitious environment develop learning and innovation, encouraging bold decisions that could change patients' lives. With countless learning opportunities in a rapidly growing business investing in technology, you'll have the chance to make a profound impact with research that makes a tangible difference.

Ready to step up and thrive with increased responsibility? Apply now to join our team!