Senior Consultant - Clinical Data Programming

Veeva Systems; Raleigh (NC); On-site; USD 80,000 - 200,000; Full time

Benefits offered by this job

Medical, dental, vision, and basiclife

Job summary

Veeva Systems seeks a Senior CDMS Consultant to help customers optimize EDC and Vault CDMS deployments in a remote, full-time capacity. You will configure study designs, develop data listings in SQL, and collaborate with clients and vendors to ensure trials meet regulatory and data quality standards.

You will bring 5+ years of EDC experience, strong technical skills in SAS, R, JSON, Python, and SQL, and a background in life sciences.

Qualifications

• 5+ years of experience with EDC clinical software solutions in end-to-end data management activities (database design, data collection, data analysis, query resolution, datasets, statistical reporting)
• Working knowledge of clinical trial processes, especially data collection and review
• Experience in programming languages such as SAS, R, JSON, Python, SQL with ability to learn new SQL-based languages
• Life sciences industry expertise in design, documentation, and data collection with customer-facing project experience
• Experience in a customer-facing role, preferably with software professional services or consulting
• Willingness to travel up to 10% (possibly international)
• Strong communication, interpersonal, and presentation skills

Responsibilities

• Act as customer and clinical site trusted advisor to configure study design for CDMS benefits and provide training
• Collaborate with customers to review clinical protocol requirements and project specs
• Drive database development activities per project plan with sponsor, CRO, and external vendors
• Coordinate with data providers to receive data and configure transfers
• Configure forms, rules, and study items in Vault CDMS and develop SQL-based listings
• Conduct on-site or remote user acceptance testing and manage feedback and issues
• Support requirements gathering and go-live activities for smooth study transition
• Communicate risks and contingency plans to ensure regulatory and process compliance
• Participate in product and best practices initiatives and support developers/testers
• Contribute to Vault CDMS product discussions to address data management challenges
• Configure and support data ingestions into DQS

Skills

SAS

R

JSON

Python

SQL

Education

Life Sciences, Computer Science, or related degree

Tools

EDC

Veeva Vault CDMS

SQL-based listings

Job description

Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $3B in revenue in our last fiscal year with extensive growth potential ahead.

At the heart of Veeva are our values: Do the Right Thing, Customer Success, Employee Success, and Speed. We're not just any public company – we made history in 2021 by becoming a public benefit corporation (PBC), legally bound to balancing the interests of customers, employees, society, and investors.

As a Work Anywhere company, we support your flexibility to work from home or in the office, so you can thrive in your ideal environment.

Join us in transforming the life sciences industry, committed to making a positive impact on its customers, employees, and communities.

The Role

Veeva Vault Clinical Data Management System (CDMS) is changing the way clinical data is managed in the industry. Vault CDMS combines EDC, coding, and Veeva Data Quality System (DQS) into one application. Veeva Data Quality System (DQS) is a next-generation clinical data platform that centralizes and automates data imports, cleaning, and management for clinical trials. To handle the massive expansion of trial data sources, Veeva DQS is designed to scale and accommodate all relevant data for a trial. Veeva Systems is looking for Senior Consultants who have life sciences software programming experience specifically in helping customers optimize the use of EDC in running their clinical trials. Additionally, the role will support internal and customer teams in the configuration of Veeva DQS and programming of SQL based listings. This is a remote, full-time permanent role with Veeva. This is a customer-facing role and we have no work location requirement if you are in close proximity to an airport and able to meet future travel requirements.

What You'll Do

• Act as the customer and clinical site trusted advisor to ensure that the study trial design is configured to meet the customer’s goals and offer full benefits of Veeva’s CDMS application while providing training and mentorship
• Work and consult with customers to review and understand clinical protocol requirements and all project specifications, applying industry and Veeva best practices
• Drive database development activities per implementation project plan by working with various members of the sponsor, CRO, and other external vendor teams
• Collaborate with clinical data providers (Central Laboratories, ECG, eCOA, IRT, etc.) to receive data and configure transfers based on requirements
• Configure forms, rules, and other study items with Veeva Vault CDMS product during development and develop custom listings based on customer data cleaning requirements using SQL-based language
• Conduct on-site or remote user acceptance testing with the customer, including coordination of all feedback, resolution of issues, and acceptance of the study
• Support requirements gathering and specification creation process for all study integrations and go-live activities to ensure a smooth transition of the study to the customer
• Communicate potential risks and contingency plans with project management to ensure process compliance with all regulatory and Veeva procedural requirements
• Participate and contribute to process product or best practices initiatives and support developers and testers during the project lifecycle
• Participate in Vault CDMS Product team discussions to convey data management activities, challenges, and end-user expectations
• Configure and support data ingestions (imports) into Veeva DQS

Requirements

• 5+ years of experience working with EDC clinical software solutions in end-to-end data management related activities (database design, data collection, data analysis, query resolution, datasets, statistical reporting)
• Working knowledge of clinical trial processes, specifically as they relate to data collection and review
• Prior experience in programming languages such as (SAS, R, JSON, Python, SQL) with the ability to learn new programming languages (SQL-based language)
• Life sciences industry and clinical trial processes (pharmaceutical, biotech, medical device companies, CRO’s, and academic & public health organizations) expertise in relation to design, documentation, and data collection – with demonstrated success during project assessment, planning, development, training, and implementation with customers
• Experience in a customer-facing role, preferably with a software professional services or consulting organization
• Proven ability to work independently and collaboratively in a dynamic, fast-moving environment and meeting project timelines with quality results
• Excellent verbal and written communication, interpersonal, and presentation skills
• Ability to travel up to 10% (may include international)

Nice to Have

• Working understanding of data management standards and guidelines (GCDMP, CDISC, SDTMIG, CDASH, ADaM)
• Experience working with system integrators for IVRS, medical coding, eSource, CTMS, eTMF, and other clinical technologies
• Integration/Programming experience with REST-based APIs
• Experience in interpreting clinical protocols and translating requirements into software specifications, including writing and reviewing technical documentation
• Experience with Veeva applications
• Locality to major life sciences customer hub
• Life Science, Computer Science, or related degree

Interviewing with Veeva

We value your time and believe in a transparent hiring process. Here is the process you can expect.

• Follow the application process and submit your resume.
• Within 3 days, you will receive a link to a personality assessment administered by a third party.
• Once you complete the assessment, our team will review your full application package and follow up via email with our decision.
• If moving to the interview stage, the process is as follows:
• A conversation with the hiring manager
• A practical case exercise
• A final conversation with our group's Senior Leader.
• Once all interviews are complete, the manager will be in touch with a final decision.

Perks & Benefits

• Medical, dental, vision, and basic life insurance
• Flexible PTO and company paid holidays
• Retirement programs
• 1% charitable giving program

Compensation

• Base pay: $80,000 - $200,000
• The salary range listed here has been provided to comply with local regulations and represents a potential base salary range for this role. Please note that actual salaries may vary within the range above or below, depending on experience and location. We look at compensation for each individual and base our offer on your unique qualifications, experience, and expected contributions. This position may also be eligible for other types of compensation in addition to base salary, such as variable bonus and/or stock bonus.

Veeva’s headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world.

Veeva is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances. If you need assistance or accommodation due to a disability or special need when applying for a role or in our recruitment process, please contact us at [e-mail].