Senior Consultant, Clinical – Process Management
Veeva Systems
 PA (Pennsylvania)
At Veeva, we build enterprise cloud technology that powers the biggest names in the pharmaceutical, biotech, consumer goods, chemical & cosmetics industries. Our customers make vaccines, life-saving medicines, and life-enhancing products that make a difference in everyday lives. Our technology has transformed these industries; enabling them to get critical products and services to market faster. Our core values, Do the Right Thing, Customer Success, Employee Success, and Speed, guide us as we make our customers more efficient and effective in everything they do.

The Role

Tired of working with old technology and legacy processes?  Looking for an opportunity to change how clinical trials, data and content are managed?  Veeva’s Vault Clinical suite is the industry’s first and only cloud platform that combines CTMS, eTMF and study startup to unify clinical operations, accelerate trial execution, and deliver real-time visibility.

Veeva Systems is looking for Senior Process Consultants who have deep clinical expertise and a passion for helping customers transform the way they manage their clinical trial processes, data, and content with our Clinical Suite of applications (Vault CTMS, Vault eTMF and Vault Study Startup).

As a key member of our Professional Services team, the Senior Process Consultant will be at the forefront of our mission and responsible for three main things:

Foster innovation and continuous improvement across organizations by challenging the status quo, creating awareness on industry trends, and leveraging clinical solutions to achieve higher standards.

Understanding our customers’ challenges and clinical needs, translating business use cases into system requirements and developing process material to support the change.

Defining global strategies for deploying process change and user adoption of the Vault Clinical applications across the enterprise.

Opportunities are available across the United States for this role. The work location is remote within the U.S.  Qualified U.S. based candidates are encouraged to apply.

What You'll Do

  • Work with customer global subject matter experts and business leaders to analyze, develop, and implement Clinical Operations processes that solve business problems and support business needs through use of Vault Clinical (eTMF, CTMS and SSU)
  • Analyze and identify potential value creating opportunities and develop requirements to ensure that business vision / use cases and recommendations translate to (and leverage) Veeva products and services. Examples include:
  • Promoting active TMF management and maintaining inspection readiness
  • Defining content maps (e.g. TMF Index, expected document lists, etc.)
  • Retiring study management trackers and manual monitoring processes
  • Using dashboards and homepages to drive start-up priorities and workloads
  • Collaborating with investigational sites through Vault technology
  • Lead client transformation engagements, develop new operating business models for Clinical Operations, and drive successful adoption and long-term success with Vault Clinical
  • Serve as primary customer liaison, managing the business change in support of the system implementation, including communication between Veeva, project team and customer
  • Support the Veeva implementation team across multiple engagements and workstreams (e.g. solution design and configuration, data migration and systems integration)
  • Develop end-user training strategies and deliver supporting material (e.g. web-based learning, user guides, etc.) to support system deployment
  • Ensure customer success from beginning to end of the engagement life cycle.
  • Identify, define, and deploy best practices through internal Preferred Vault Practices, aligning with industry guidance and maintaining competitive advantage

Requirements

  • 10+ years’ direct experience in clinical operations, monitoring operations, Study Startup, TMF operations and/or trial management
  • Knowledge of clinical trial processes across pharmaceuticals, device and/or biotech sectors, specifically as they related to document and data collection
  • Expert on life sciences compliance, regulatory, and sponsor quality assurance requirements
  • Proven track record leading high-impact global process transformation programs for life sciences companies, including:
  • Workshop facilitations
  • Client interviews / focus groups
  • Process optimization
  • Influencing business leaders
  • Change management, training, and deployment strategies
  • Ability to quickly understand business use cases and opportunities for change, to create corresponding process and business model improvements
  • Proven ability to manage diverse stakeholders and ensure delivery to a high degree of satisfaction
  • Ability and willingness to “roll up your sleeves” to analyze and develop process and training material
  • Proven ability to work independently in a dynamic, fast-moving environment
  • Strong understanding of governance models for process and system management
  • Ability to travel 50-75%
  • Bachelor’s degree or equivalent required
  • Qualified candidates must be legally authorized to be employed in the United States. Veeva Systems does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

Nice to Have

  • Direct experience with clinical software solutions such as Veeva Vault, Documentum, BioClinica CTMS, Parexel IMPACT, Medidata CTMS and GoBalto
  • Life Science, Computer Science, Change Management or related degree
  • Direct experience in Quality Assurance, Business Analyst, clinical process improvement, services delivery management or line management of Clinical Operations or relevant functional areas
  • Locality to major life sciences customer hub (NJ; Boston, MA; San Francisco, CA; Philadelphia, PA; Chicago, IL)
  • Program Management experience, either having led or supported large scale programs
  • Change Management experience, either having led or supported change management programs

Perks & Benefits

  • Flexible PTO
  • Allocations for continuous learning & development
  • Health & wellness programs


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.