Job Summary:
We are seeking a highly skilled Project Manager with in-depth experience in Veeva applications and other essential Life Sciences platforms to manage and optimize our client’s ecosystem for clinical, regulatory, quality, and operational excellence. This role requires experience with complex project planning, strong cross-functional leadership, and a hands-on approach to Veeva RIM, eTMF, QMS, and LIMS, as well as Netsuite ERP, Conga for contract management, and LSAF Biostats analytics.
Key Responsibilities:
- Project Management: Oversee the lifecycle of multiple projects involving Veeva applications (RIM, eTMF, QMS, LIMS) and integrations with other enterprise systems, ensuring projects are delivered on time, within scope, and on budget.
- Veeva Platform Expertise: Lead the implementation, upgrades, and optimizations of Veeva systems, including Veeva RIM (Regulatory Information Management), Veeva eTMF (electronic Trial Master File), Veeva QMS (Quality Management System), and Veeva LIMS (Laboratory Information Management System).
- Cross-Platform Integration: Manage integrations with Netsuite ERP for finance and inventory management, Conga for Contract Lifecycle Management, and the LSAF Biostats analytics platform to ensure seamless data flow and functionality across all systems.
- Stakeholder Engagement: Act as the primary liaison between technical teams and business stakeholders, ensuring alignment with business requirements and fostering strong partnerships across departments.
- Risk and Issue Management: Identify project risks, issues, and dependencies proactively, and develop mitigation and contingency plans.
- Data Migration and Validation: Support data migration, system validation, and testing, especially during upgrades to newer versions of Veeva QMS and integrations with LIMS and other platforms.
- Change Management and Training: Develop and execute change management strategies, including training programs for end-users to maximize adoption and ensure smooth transitions.
- Documentation and Compliance: Maintain detailed project documentation, ensuring compliance with regulatory and quality standards (GxP, FDA, EMA) relevant to Life Sciences systems.
Experience:
- 5+ years of project management experience in the Life Sciences industry, with 2+ years managing projects involving Veeva applications.
- Demonstrated experience with Veeva RIM, Veeva eTMF, Veeva QMS (with upgrade experience), and Veeva LIMS.
- Experience integrating Netsuite ERP (finance and inventory), Conga (Contract Lifecycle Management), and LSAF Biostats analytics platform.
- Technical Skills: Strong familiarity with Veeva, Netsuite, and Conga platforms, as well as experience in data integration, data migration, and system validation.
- Project Management Skills: Proficiency in project management methodologies (e.g., Agile, Waterfall), and in using tools like MS Project, Smartsheet, or Jira.
- Soft Skills: Excellent communication, collaboration, and problem-solving skills, with the ability to influence and manage cross-functional teams and stakeholders.
- Regulatory Knowledge: In-depth understanding of regulatory requirements (FDA, EMA, GxP) for clinical, regulatory, and quality applications in the Life Sciences industry.
Qualifications:
- Education: Bachelor’s degree in Life Sciences, Business, Information Technology, or a related field (Advanced degree or PMP certification preferred).
Preferred Qualifications:
- PMP, PRINCE2, or equivalent project management certification.
- Prior experience with change management and end-user training specific to Life Sciences platforms.
- Knowledge of analytics platforms like LSAF for supporting biostatistics and research workflows.