Astrazeneca is a global, science-led, patient-focused pharmaceutical company. it is dedicated to transforming the future of healthcare by unlocking the power of what science can do for people, society and the planet.
Post: Associate Director Study Data Manager
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.
Job Description:
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.
Candidate Profile:
- 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.
- 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.
locations: India - Bangalore
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