Veeva Clinical Consultant / Clinical Data Management Specialist Experience: 10-15 years hands-on ... Knowledge of Agile or Waterfall project methodologies. * Experience with Veeva Vault administration ...
Veeva Clinical Consultant / Clinical Data Management Specialist Experience: 10-15 years hands-on ... Knowledge of Agile or Waterfall project methodologies. * Experience with Veeva Vault administration ...
Project Manager I - Cell & Gene Therapy (Sponsor Dedicated - US Remote; Preference for Hybrid Los An
Wilmington, DE · On-site
Proficiency in clinical systems (e.g., CTMS, EDC, eTMF ) and project management tools. * Confident in leading sponsor calls , presenting KPIs, and contributing to operational governance. * Bachelor ...
Project Manager I - Cell & Gene Therapy (Sponsor Dedicated - US Remote; Preference for Hybrid Los An
Wilmington, DE · On-site
Proficiency in clinical systems (e.g., CTMS, EDC, eTMF ) and project management tools. * Confident in leading sponsor calls , presenting KPIs, and contributing to operational governance. * Bachelor ...
Reviews the project oversight dashboards and other clinical trial systems (e.g. Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes ...
Reviews the project oversight dashboards and other clinical trial systems (e.g. Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes ...
Edc Project Manager information
Is EDC a good place to work?
Can I make 100k as a project manager?
What projects do EDC employees work on?
What are some common challenges faced by EDC Project Managers when implementing new electronic data capture systems?
What are the key skills and qualifications needed to thrive as an EDC Project Manager, and why are they important?
What are EDC Project Managers?
What is the highest paying project manager?
What is the difference between Edc Project Manager vs Electrical Project Manager?
| Aspect | Edc Project Manager | Electrical Project Manager |
|---|---|---|
| Certifications | PMP, OSHA, EDC-specific training | PMP, OSHA, Electrical licenses |
| Work Environment | Energy, utility, and infrastructure projects | Construction, industrial, and commercial electrical projects |
| Industry Usage | Common in energy distribution and utility sectors | Common in construction and industrial sectors |
| Job Focus | Distribution systems, substations, and energy delivery | Building wiring, electrical systems, and installations |
The Edc Project Manager primarily oversees energy distribution and utility infrastructure projects, focusing on energy delivery systems. In contrast, the Electrical Project Manager handles a broader range of electrical construction projects, including commercial and industrial wiring. Both roles require similar certifications but differ in industry focus and project types.
Other
Posted 13 days ago
Job description
Experience: 10-15 years hands-on
Job Summary:
Responsible for implementing, configuring, and supporting Veeva Clinical applications including CTMS, EDC, CDB, Site Connect, and ODC. Collaborate with clinical operations, data management, sponsors, CROs, and study teams to ensure efficient clinical trial execution, data quality, and regulatory compliance throughout the study lifecycle. Veeva's clinical platform is designed to connect clinical operations and clinical data management on a unified cloud platform.
- Configure and support Veeva CTMS for study planning, site management, monitoring visits, milestones, and issue tracking.
- Build and maintain Veeva EDC studies, including eCRFs, edit checks, visit schedules, and subject management.
- Perform clinical data review, query generation, reconciliation, and database cleaning using Veeva CDB (Clinical Database/Data Workbench).
- Support Veeva Site Connect to streamline communication and data exchange between sponsors, CROs, and clinical sites.
- Configure ODC/Open Data Capture (or OpenEDC where applicable) for integration with external data sources and third-party EDC systems.
- Coordinate User Acceptance Testing (UAT), system validation, and production deployments.
- Monitor data quality and resolve discrepancies to support timely database lock.
- Create and maintain study documentation, validation documents, SOPs, and user guides.
- Collaborate with Clinical Operations, Data Management, Biostatistics, Medical Coding, and Safety teams.
- Support protocol amendments, mid-study changes, and system enhancements.
- Manage user access, roles, permissions, and security within the Veeva Vault platform.
- Troubleshoot application issues and provide end-user training and production support.
- Ensure compliance with ICH-Google Cloud Platform, FDA 21 CFR Part 11, and applicable regulatory requirements.
- Experience with Veeva CTMS
- Experience with Veeva EDC
- Knowledge of Veeva CDB/Data Workbench
- Experience with Veeva Site Connect
- Knowledge of ODC/OpenEDC integrations
- Clinical trial lifecycle knowledge (Phase I–IV)
- Clinical Data Management (CDM)
- eCRF design and edit check configuration
- Query management and data cleaning
- UAT and system validation
- SQL (preferred)
- SDTM/CDISC basics
- Strong analytical and communication skills
- Bachelor's or Master's degree in Life Sciences, Pharmacy, Biotechnology, or a related field.
- Experience working with pharmaceutical companies or CROs.
- Knowledge of Agile or Waterfall project methodologies.
- Experience with Veeva Vault administration is an advantage.
About Arnex Solutions
Sourced by ZipRecruiter
Industry
It services
Company size
11 - 50 Employees
Headquarters location
Kearny, NJ, US
Year founded
2014