AstraZeneca contributes meaningfully to the UK beyond the provision of our medicines and the benefits they provide to the health of the nation. We commissioned a report in 2009 to measure our significant investment to the UK economy, which includes investment in jobs and wealth creation. Oxera, an independent economic consultancy provided the analysis for this report.
Post : Clinical Data Manager I
Job Description
Accountabilities
Assist with Study level CDM administrative support based on the relevant model and DM Vendor. This may include but is not limited to activities related to the study start up, conduct and closeout phases. (i.e., documentation review and/or creation, User Access Testing, query management, data cleaning and reviews, third party data reconciliation in accordance with the project study model, KPIs and timelines.)
• Day to day responsibilities may include but are not limited to:
* Study status reporting to the relevant clinical study team members, (e.g., provide data to clinical teams for performing medical and clinical reviews, coordination of instream data review, lab data review, etc.)
* Collaboration with Data Management Vendor regarding upcoming deliverables and milestone achievements (i.e., snapshots, interim, and migrations).
* Oversight of the data quality, documentation quality, and types of these deliverables and milestones.
• Support DM Delivery Leads to maintain CDM specified systems and types of deliverables, milestone achievements, risks and mitigations and data transfer agreements, and other study administrative needs.
• Support DM Delivery Leads in oversight of Trial Master File compliance for audit readiness. May include activities related to study expected document Lists and quality compliance checks.
• Support DM Delivery Leads in User Acceptance Testing of internal and external electronic Data Capture systems as required.
• Provides support to the resolution of issues related to Clinical Data Management deliverables and inputting ideas to help resolve issues and contribute to continuous improvement.
• Performs any CDM related ad-hoc requests as requested by the DM Leads.
Candidate Profile
• University or college degree in the life sciences or related subject, pharmacy, nursing or equivalent relevant degree
• Languages: Fluent English (oral and written)
• Attention to detail to ensure quality
• Good verbal and written skills
• Ability to work flexibly on simultaneous projects and proactively manage time to meet own deadlines.
• Strong interpersonal skills and proven ability to communicate effectively in a global environment.
• Basic understanding of clinical trials methodology, Clinical Data Management, GCP and medical terminology
Additional Information
Qualification : University or college degree in the life sciences, pharmacy
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 21-Nov-2024
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