Consultant (Project Management) - CDMS Services (Remote)

Veeva is a mission-driven organization that aspires to help our customers in Life Sciences and Regulated industries bring their products to market, faster. We are shaped by our values: Do the Right Thing, Customer Success, Employee Success, and Speed. Our teams develop transformative cloud software, services, consulting, and data to make our customers more efficient and effective in everything they do. Veeva is a work anywhere company. You can work at home, at a customer site, or in an office on any given day. As a Public Benefit Corporation, you will also work for a company focused on making a positive impact on its customers, employees, and communities.The RoleVeeva Vault Clinical Data Management System (CDMS) is changing the way clinical data is collected, managed and reviewed in the industry. Vault CDMS combines EDC, coding, data cleaning and reporting in one application. Gone are the days of complex integrations that limit clinical data availability, now research teams can make faster and more informed decisions.Veeva Systems is looking for a Consultant with extensive project management and clinical trial expertise and a passion for helping customers transform the way they manage their clinical trial data and content with Vault CDMS.As a key member of our CDMS Professional Services team, you will be at the forefront of our mission with customers and responsible for a range of tasks and activities. You will work to understand our customers’ data management challenges and clinical needs, establish and maintain project scope and timelines, project financials, and facilitate project communication to ensure a successful implementation based on the customers’ requirements.You will also be leading and mentoring talented project team members implementing and configuring the solution. Becoming a customer advocate, working closely with other Veeva teams (Product, Sales, Strategy) to ensure customer success today and in the future will also be an essential part of your role at Veeva.Opportunities are available across Europe for this role. The work location is remote within the EU. Qualified EU-based candidates are encouraged to apply.

What You'll Do

• Primary customer liaison managing communication between the project team, customer and internal stakeholders,
• Track and communicate project status, plans issues, timelines, action items, and budgets,
• Manage project scope respecting the customer team and Veeva needs,
• Assess and track project risk and develop mitigation plans as necessary,
• Work with the project team to scope required effort and define timelines,
• Lead the customer in the rapid configuration and implementation of applications to support clinical trials with the Vault CDMS platform as per our execution methodology,
• Work closely with the customer and project team to identify and ensure delivery against key business drivers,
• Support pre-sales activities from a services perspective, including defining customer needs, scoping engagements, and delivering Statements of Work,
• Mentor project team and junior consultants in the CDMS Services organization,
• Ensure customer success from beginning to end of the project life cycle,
• Ensure process compliance with all regulatory and Veeva procedural requirements,
• Identify and contribute to opportunities for process improvement of Veeva’s CDMS delivery methodology and process

Requirements

• 5+ years direct experience working with EDC clinical software solutions in clinical operations, and/or trial management role in a project management capacity
• Working knowledge of Clinical Trial processes across pharmaceuticals, device and/or biotech sectors, specifically as they relate to document and data collection,
• Proven track record leading high-impact global system implementation programs for life sciences as a consultant, business or IT lead and/or business sponsor for clinical systems,
• Proven ability to manage diverse stakeholders, and ensure delivery to a high degree of satisfaction,
• Ability and willingness to “roll up your sleeves” to implement a clinical solution,
• Ability to quickly understand business requirements,
• Proven ability to work independently in a dynamic, fast-moving environment, but also as part of a team,
• Logical approach to problem-solving and excellent eye for detail,
• Ability to manage multiple tasks and project deliverables,
• Proven track record of meeting project timelines/deliverables and attention to detail, process, deadlines, and quality results,
• Excellent verbal and written communication in English,
• Strong interpersonal and presentation skills,
• Expert on life sciences compliance and computer systems validation requirements,
• Ability to travel 25-30% (may include international),
• 4-year degree required

Nice to Have

• Computer Science, Life Science or related degree preferred,
• Familiarity with MedTech industry standards and regulatory requirements (e.g.: QSR, ISO13485, 2017/745, 2017/746),
• Direct experience with regulated systems or data-driven applications such as Veeva Vault solutions, SharePoint, NextDocs, Documentum, FirstDoc /FirstPoint, Trackwise, Medidata, Liquent Insight…
• SaaS/Cloud delivery experience,
• Experience in Services Delivery Management or Pre-Sales presentations and demonstrations

Perks & Benefits

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