Astra Zeneca Data Manager Job Opening – Life Sciences Apply
Senior Clinical Data Manager II – Job Opening
About AstraZeneca
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines for some of the world’s most serious diseases. At AstraZeneca, we are dedicated to being a Great Place to Work.
About the Role
Job Description
As a Senior Clinical Data Manager II, you will be responsible for coordinating the Clinical Data Management (CDM) deliverables on assigned clinical studies. You may also act as a Core member of the Global Study Team and lead studies with less complexities. Collaboration with DM vendors and various departments on a local and/or global level is necessary to ensure the successful execution of each study.
Typical Accountabilities
- Coordinate the Clinical Data management deliverables on assigned studies
- Demonstrate leadership and operational knowledge in the planning and delivery of CDM deliverables
- Communicate and collaborate effectively with all study level team members
- Oversight of the day-to-day operational aspects of CDM for assigned studies
- Provide input into CDM related activities associated with regulatory inspections/audits
- Responsible for compliance to Trial Master File requirements relating to DM Vendor
- Support Senior Leaders to oversee CDM Vendor performance
- Drive adherence to AZ CDM standards and processes for data quality
- Mentor junior Clinical Data management colleagues
- Perform any CDM related ad-hoc requests from Line Manager or superior
Education, Qualifications, and Experience
Essential:
- University or college degree in the life sciences or related subject, pharmacy, nursing or equivalent relevant degree
- 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
- Demonstrated experience of clinical databases, different clinical data management systems, and electronic data capture (EDC)
- Ability to work flexibly on simultaneous projects and meet deadlines
- Excellent written and verbal communication skills
- Ability to work in a distributed team environment
- Excellent organizational and analytical skills with high attention to detail
Desirable:
- Knowledge of clinical and pharmaceutical drug development process
- Understanding of clinical data system design/development/validation and system interoperability
- Ability to work effectively with external partners
- Knowledge of database structures, programming languages, data standards (CDISC), and practices
- Knowledge of SQL or SAS software
If you meet the qualifications and are passionate about making a difference in the field of clinical data management, we encourage you to apply for the position through the link below.
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