We are looking for a dedicated Veeva Clinical Operations Specialist to support the management and execution of clinical trials using the Veeva Vault Clinical platform. The ideal candidate will have experience in clinical operations, strong knowledge of clinical trial processes, and hands-on experience with Veeva applications. This role will involve collaborating with cross-functional teams to ensure the successful execution of clinical studies, maintaining compliance with regulatory requirements, and optimizing the use of Veeva tools.
Key Responsibilities:
· Clinical Trial Management:
- Oversee the planning, execution, and closeout of clinical trials, ensuring compliance with Good Clinical Practice (GCP) and regulatory standards.
- Coordinate with study teams to develop and manage study timelines, budgets, and resource allocation.
· Veeva Vault Clinical Platform Utilization:
- Configure and manage the Veeva Vault Clinical platform to support clinical trial activities, including study setup, site management, and subject tracking.
- Ensure that all trial-related documentation is maintained accurately and is readily accessible within Veeva.
· Data Management and Reporting:
- Monitor data entry and ensure data integrity within Veeva Vault, identifying and resolving discrepancies as needed.
- Generate reports and dashboards to track trial progress, site performance, and recruitment metrics.
· Cross-Functional Collaboration:
- Collaborate with internal teams, including Regulatory Affairs, Data Management, and Quality Assurance, to ensure seamless trial execution.
- Act as a liaison between clinical teams and external vendors or partners regarding clinical trial processes.
· Training and Support:
- Provide training to clinical staff and study teams on Veeva Clinical functionalities and best practices.
- Develop training materials, user manuals, and quick reference guides to facilitate effective use of the Veeva platform.
· Quality Assurance and Compliance:
- Ensure compliance with company policies, regulatory requirements, and industry standards throughout the clinical trial lifecycle.
- Participate in audits and inspections, providing necessary documentation and support.
· Continuous Improvement:
- Identify areas for process improvement within clinical trial management and propose enhancements to workflows.
- Stay informed about Veeva platform updates and industry trends to optimize system utilization.
· Proficiency in Veeva Vault Clinical and familiarity with other clinical data management systems.
· Excellent organizational and multitasking skills, with the ability to manage competing priorities effectively.
· Strong analytical and problem-solving abilities, with attention to detail.
· Effective communication and interpersonal skills, with the ability to collaborate with cross-functional teams.
· Assist the sales team as pre-sales solution architect- technical knowledge and presentations. Understand customer requirements and provide sales support. Conduct product demonstrations, both online and face-to-face.
· Identify and understand the specific needs of clients. Design and develop tailored solutions that meet client requirements. Prepare and present proposals to clients.
· Respond to technical and functional product queries during the sales process.
· Veeva Vault Development cloud certification (Clinical / CTMS)
Certifications:
- Clinical Research Coordinator (CRC) or Clinical Research Associate (CRA) certification is a plus.
Job Description:We are looking for a dedicated Veeva Clinical Operations Specialist to support the management and execution of clinical trials using the Veeva Vault Clinical platform. The ideal candidate will have experience in clinical operations, strong knowledge of clinical trial processes, and hands-on experience with Veeva applications. This role will involve collaborating with cross-functional teams to ensure the successful execution of clinical studies, maintaining compliance with regulatory requirements, and optimizing the use of Veeva tools.
Key Responsibilities:
· Clinical Trial Management:
- Oversee the planning, execution, and closeout of clinical trials, ensuring compliance with Good Clinical Practice (GCP) and regulatory standards.
- Coordinate with study teams to develop and manage study timelines, budgets, and resource allocation.
· Veeva Vault Clinical Platform Utilization:
- Configure and manage the Veeva Vault Clinical platform to support clinical trial activities, including study setup, site management, and subject tracking.
- Ensure that all trial-related documentation is maintained accurately and is readily accessible within Veeva.
· Data Management and Reporting:
- Monitor data entry and ensure data integrity within Veeva Vault, identifying and resolving discrepancies as needed.
- Generate reports and dashboards to track trial progress, site performance, and recruitment metrics.
· Cross-Functional Collaboration:
- Collaborate with internal teams, including Regulatory Affairs, Data Management, and Quality Assurance, to ensure seamless trial execution.
- Act as a liaison between clinical teams and external vendors or partners regarding clinical trial processes.
· Training and Support:
- Provide training to clinical staff and study teams on Veeva Clinical functionalities and best practices.
- Develop training materials, user manuals, and quick reference guides to facilitate effective use of the Veeva platform.
· Quality Assurance and Compliance:
- Ensure compliance with company policies, regulatory requirements, and industry standards throughout the clinical trial lifecycle.
- Participate in audits and inspections, providing necessary documentation and support.
· Continuous Improvement:
- Identify areas for process improvement within clinical trial management and propose enhancements to workflows.
- Stay informed about Veeva platform updates and industry trends to optimize system utilization.
· Proficiency in Veeva Vault Clinical and familiarity with other clinical data management systems.
· Excellent organizational and multitasking skills, with the ability to manage competing priorities effectively.
· Strong analytical and problem-solving abilities, with attention to detail.
· Effective communication and interpersonal skills, with the ability to collaborate with cross-functional teams.
· Assist the sales team as pre-sales solution architect- technical knowledge and presentations. Understand customer requirements and provide sales support. Conduct product demonstrations, both online and face-to-face.
· Identify and understand the specific needs of clients. Design and develop tailored solutions that meet client requirements. Prepare and present proposals to clients.
· Respond to technical and functional product queries during the sales process.
· Veeva Vault Development cloud certification (Clinical / CTMS)
Certifications:
- Clinical Research Coordinator (CRC) or Clinical Research Associate (CRA) certification is a plus.