Job Title: Associate Director Study Data Manager
Career Level - E
Introduction to Role:
Join us at AstraZeneca as an Associate Director Study Data Manager, where you will be responsible for coordinating the Clinical Data Management (CDM) deliverables on assigned clinical studies. You will be a member of the Global Study Team (GST) and the main point of contact for the Data Management (DM) vendor. This role is crucial in ensuring CDM deliverables follow standards and meet data quality, maintaining business continuity for CDM processes and standards including integrity of the clinical database for the relevant studies.
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 identifying risks and collaborating with the DM Vendor to mitigate them, driving adherence to AZ DM standards and processes for data quality, and providing input into DM related activities associated with regulatory inspections/audits for assigned studies. You will also oversee DM Vendor performance, review, assess and manage DM Vendor delivery against KPIs, budget and overall performance.
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.
- 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 unleash 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, we are committed to following the science. As part of our Oncology R&D team, you will be at the heart of our 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, there are many opportunities to work with new and novel drugs. 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.
Ready to make a difference? Apply now and join us in our mission to eliminate cancer as a cause of death!
Date Posted
Closing Date
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.
اطلب مساعدة الخبراء لكتابة سيرة ذاتية مميزة.