Post: Senior Clinical Data Manager I
Job Description:
Assist with coordinating Clinical Data Management (CDM) deliverables on assigned clinical studies and may serve as an expert on CDM processes, standards, and technology. Potential membership in the Global Study Team (GST) for less complex studies. Collaborate with DM vendors and liaise with various departments on a local and/or global level to ensure each study aligns with the specified model. Maintain Business Continuity for CDM processes and standards, including ensuring the integrity of the clinical database for relevant studies. May work under the direction of an experienced Principal Clinical Data Manager.
Accountabilities at AstraZeneca:
In this role, provide study-level CDM administrative support based on the relevant model and DM Vendor. Activities include, but are not limited to, tasks related to the study start-up, conduct, and closeout phases. Responsibilities also include study status reporting to relevant clinical study team members, collaboration with Data Management Vendor regarding upcoming deliverables and milestone achievements, and oversight of the data quality, documentation quality, and types of these deliverables and milestones.
Candidate Profile:
- University or college degree in 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.
- Experience with clinical databases, different clinical data management systems, and electronic data capture (EDC).
- Understanding and experience in query management processes and reconciliation activities.
- Ability to work flexibly on simultaneous projects and proactively manage time to meet own deadlines.
- Excellent written and verbal communication skills.
- Ability to work in a global team environment.
- Excellent organizational and analytical skills with high attention to detail.
Additional Skills:
- Demonstrated knowledge of clinical and pharmaceutical drug development processes.
- 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.
- Understanding of clinical data system design/development/validation and system interoperability.
- Ability to work effectively with external partners.
- Knowledge of SQL, 4GL, VBA, or R software.
Additional Information:
- Qualification Required at AstraZeneca: University or college degree in life sciences or related subject, pharmacy, nursing.
- Location: Bangalore.
- Industry Type: Pharma/ Healthcare/ Clinical research.
- End Date: 30th November 2023.
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