PUNE · FULLTIME
Data Manager
PrimeVigilance
Pune · onsite · Posted 27d ago
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Section · 01
About this role
- Perform validation of EDC Systems and associated DM reports or listings
- Perform validation of EDC and SAS edit checks
- Manage and Create EDC user accounts
- Update and maintain DM documentation as directed by the Lead Data Manager (LDM) or Project
- Performs specified activities that contribute to the creation of database specifications, database build and user acceptance testing during database and edit check development
- May enter Data from trial documents into data entry system
- May perform Medical Coding
- Manage the entry, review, and tracking of Local/Central Lab reference ranges
- Attend internal/external teleconferences as needed
- May create and review study metric reports for internal/external project teams
- Notify management of roadblocks for getting processes done in a timely manner and offer possible solutions
- Provide the PDM with status updates on tasks that are assigned
- Escalates significant issues promptly to the study team
- Support the Lead Data Manager with all DM related close-out activities and DBL checklist (query resolution, final reconciliations, development of reports) Qualifications
- 4-8 years of relevant clinical data management experience in pharmaceutical industry and/or contract research organization and/or similar data management experience in a non-clinical environment
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
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Section · 02
Skills
Section · Company
About PrimeVigilance
PrimeVigilance
501-1000
employees
2008
18 years old
Guildford
United Kingdom
₹9.7L PA avg
Avg at PrimeVigilance
About
PrimeVigilance, an Ergomed company, was set up by former Pharmacovigilance Regulators in 2008. We have grown to become the leading Pharmacovigilance specialist company, delivering global solutions for both clinical safety and post-marketing pharmacovigilance, as well as medical information from our offices. Having successfully delivered Pharmacovigilance (PV) and Medical Information (MI) services for over 14 years, our experience enables us to offer a comprehensive, top quality, cost-effective, and innovative safety solution. Our flexible approach, tailor-made to work with clients, allows us to deliver the services that meet your clinical and post-marketing needs.
From its operational hubs based in Europe, the USA, and Japan. PrimeVigilance manages a global Pharmacovigilance system with a choice of leading drug safety databases, stretching to more than 100 countries.
• 900+ highly qualified professionals
• Global leader in QPPV services
• 24/7 multilingual call center
• Choice of leading drug safety databases
• Robotic Process Automation (RPA) expertise
• Access to regulatory experts and key opinion leaders
GLOBAL LIFE CYCLE MANAGEMENT SERVICES
• PHARMACOVIGILANCE
• PHARMACOEPIDEMIOLOGY & BENEFIT-RISK MANAGEMENT
• AUDIT & INSPECTION
• QUALITY MANAGEMENT
• REGULATORY SCIENCE
Industries
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9 reviews
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Career growth
2.9
Work-life
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