Associate Director Study Data Manager
3 weeks ago
**Job Title: Associate Director Study Data Manager**
**Career Level - E**
Introduction to Role:
Join us as an Associate Director Study Data Manager, where you will be 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, ensuring CDM deliverables follow standards and meet data quality. This role is an opportunity to maintain business continuity for CDM processes and standards, including the integrity of the clinical database for 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. You will also provide input into DM related activities associated with regulatory inspections/audits for assigned studies and oversee DM Vendor performance.
**Essential Skills/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.
- Demonstrated knowledge of clinical and pharmaceutical drug development process.
- 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's Oncology R&D department, we push the boundaries of science to change the practice of medicine and transform the lives of patients living with cancer. We are united in our vision to eliminate cancer as a cause of death. With one of the broadest and deepest Oncology pipelines in the industry, there are many opportunities to work with new and novel drugs. We believe in growing together, providing a place where everyone can have a voice. We are diligent, committed to our science-driven approach, with a sharp focus on outcomes. We foster a mindset of courage, where everyone is empowered to step up, innovate and work at pace.
Are you ready to make a meaningful difference in the lives of
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