Offer summary

Qualifications:

5+ years of clinical operations experience, particularly with Veeva Vault Clinical., Strong understanding of regulatory standards and Good Clinical Practice (GCP)., Excellent organizational, multitasking, and analytical skills., Effective communication skills for cross-functional collaboration..

Key responsabilities:

Oversee the full lifecycle of clinical trials, ensuring compliance with GCP and regulatory standards.

Configure and manage the Veeva Vault Clinical platform for trial operations.

Monitor data quality and generate reports to track trial progress and performance.

Train clinical staff on Veeva functionalities and ensure adherence to quality assurance standards.

Job description

This is a remote position.

Job Title: Veeva Clinical Operations Consultant

Contract Duration: 12 months

Location: New York, NY / Boston, MA (Hybrid and Remote)

Job Summary:

Capgemini seeks a skilled Veeva Clinical Operations Specialist to drive the efficient management and execution of clinical trials using the Veeva Vault Clinical platform. This role involves supporting clinical study operations, ensuring regulatory compliance, and collaborating closely with cross-functional teams to meet project objectives. The ideal candidate will have strong clinical operations experience and a deep understanding of Veeva applications.

Key Responsibilities:

Clinical Trial Management

Oversee the full lifecycle of clinical trials, ensuring compliance with Good Clinical Practice (GCP) and regulatory standards.
Work with study teams to plan, execute, and close out trials, managing study timelines, budgets, and resources.

Veeva Vault Clinical Platform Utilization

Configure and manage the Veeva Vault Clinical platform to support trial operations, including study setup, site management, and subject tracking.
Maintain and organize all trial-related documentation for accuracy and accessibility within Veeva.

Data Management and Reporting

Monitor data quality within Veeva Vault, ensuring data integrity and resolving discrepancies.
Generate reports and dashboards to track trial progress, site performance, and recruitment metrics.

Cross-Functional Collaboration

Work closely with Regulatory Affairs, Data Management, Quality Assurance, and other teams to ensure smooth trial execution.
Act as a liaison between clinical teams and external vendors for effective communication and alignment.

Training and Support

Train clinical staff and study teams on Veeva Clinical functionalities and best practices.
Develop user guides, training materials, and reference tools to enhance Veeva platform utilization.

Quality Assurance and Compliance

Ensure adherence to company policies, regulatory requirements, and industry standards throughout clinical trials.
Participate in audits and inspections, providing documentation and other support as required.

Continuous Improvement

Identify opportunities for enhancing clinical trial workflows and propose process improvements.
Keep current with Veeva updates and industry developments to optimize platform use.

Required Qualifications:

Hands-on experience with Veeva Vault Clinical and familiarity with other clinical data management systems.
Strong clinical trial management background with an understanding of regulatory standards.
Excellent organizational and multitasking skills with the ability to prioritize effectively.
Strong analytical, problem-solving, and communication skills to work cross-functionally.

Preferred Skills:

Clinical Research Coordinator (CRC) or Clinical Research Associate (CRA) certification.
Experience with additional Veeva tools and page customizations.

Why Join Us?