Senior Consultant - CDMS Services (EDC)

As a Senior Consultant - CDMS Services (EDC) at Veeva Systems, you will engage directly with clients to understand their clinical trial protocols and oversee the configuration of the Veeva Vault Clinical Data Management System. Your expertise will be vital in conducting user acceptance testing, supporting requirements gathering, and ensuring the smooth transition of studies to customers. You will also inform project management of any risks and contribute to best practices initiatives.

To qualify for the Senior Consultant - CDMS Services (EDC) role at Veeva Systems, candidates should possess at least 2 years of experience in data management activities, ideally within clinical operations or trial management. A robust understanding of the life sciences, clinical trial processes, and experience with EDC software solutions is essential. Excellent communication skills and the ability to work both independently and collaboratively in a fast-paced environment are also crucial.

Yes, the Senior Consultant - CDMS Services (EDC) position at Veeva Systems requires about 20-25% travel, which may include both domestic and international trips. This travel is essential for meeting with clients and ensuring that user acceptance testing and other project engagements are conducted effectively.

In the role of a Senior Consultant - CDMS Services (EDC) at Veeva Systems, you will work on diverse clinical trial projects that involve configuring and managing clinical data through the Veeva Vault CDMS. You'll collaborate closely with customers to ensure their unique needs are met while facilitating data collection, analysis, and reporting processes to streamline clinical operations.

At Veeva Systems, employee success for a Senior Consultant - CDMS Services (EDC) involves a strong support system where personal growth and professional development are prioritized. Employees are encouraged to cultivate their skills, become trusted advisors to clients, and contribute to innovative solutions that transform the clinical trial landscape. The company promotes a values-driven culture that celebrates collaborative achievement and encourages a work-life balance.

When tackling client requirements for clinical data management, I initiate a detailed discussion with stakeholders to fully grasp their needs. I ensure to ask specific questions regarding their protocols and what they aim to achieve. This approach allows me to capture essential details and configure the Veeva CDMS efficiently, addressing challenges early on.

Certainly! I recall a project where the client faced regulatory changes mid-trial. I promptly organized a meeting to assess the impact on our existing data management plan and proposed adjustments that aligned with new guidelines. By maintaining clear communication and collaborating across teams, we delivered the project on time while ensuring compliance.

My experience with EDC solutions spans over two years, during which I worked extensively with clinical operations teams to implement and optimize EDC tools. I’ve configured study designs, conducted user training, and facilitated the usability of these solutions to streamline data collection processes effectively.

To ensure that project timelines and deliverables are met, I adopt a proactive approach to project management. This includes establishing clear milestones, regular check-ins with the team, and maintaining an open line of communication. I believe in setting realistic deliverable timelines and adjusting quickly if any challenges arise.

The most critical skill for a Senior Consultant in CDMS services is effective communication. It’s imperative to understand and articulate client needs, provide clear guidance, and collaborate with various teams during the project lifecycle. This skill ensures that everyone stays aligned and focused on achieving the project goals.

During acceptance testing, I prioritize user feedback by documenting all input meticulously and categorizing it based on urgency and impact. I maintain clear communication with users to validate their concerns and collaborate with the development team to implement necessary changes, ensuring that the final product meets user expectations.

Staying updated on clinical trial regulations is crucial, so I dedicate time to continuous learning through industry seminars, webinars, and relevant publications. Additionally, I participate in professional networks and forums where experts share insights. This proactive approach ensures I’m always informed and can adapt our processes accordingly.

Translating a clinical protocol into software specifications involves a deep dive into the protocol's details to identify key data elements, processes, and requirements. I would break down the protocol into specific test cases, create a mapping document that aligns these elements with the functionality of Veeva's CDMS, and validate it through collaboration with clinical teams.

I have over two years of experience in project management, where I was responsible for overseeing various data management projects. This role involved coordinating with cross-functional teams, managing timelines, and ensuring compliance with project goals. I utilized project management tools to track progress and addressed any issues swiftly, fostering a team-oriented environment.

The key benefits of using Veeva Vault CDMS include streamlined data integration, enhanced data accessibility, and expedited decision-making processes. This platform allows clinical teams to work cohesively, reducing the complexities of managing separate systems and fostering greater collaboration from study design to reporting.