Sr. Manager, Planisware Process & Data Standards Lead

About the Role

Key Responsibilities

• Lead standardized process development and governance for Planisware.
• Oversee change management and chair the FCAC.
• Own data quality, data dictionary (MDM), and governance frameworks.
• Drive cross-functional training and enablement strategies.
• Coordinate system development priorities and manage third-party vendors.

Requirements

• Bachelor's degree in Life Sciences, Business Administration, Information Systems, or a related field.
• An advanced degree (e.g., MBA, MS, or related graduate degree) is preferred.
• Professional certifications in Project Management (e.g., PMP), Lean Six Sigma, Change Management (e.g., Prosci), or Data Governance are a strong plus.
• Minimum 7 years of experience in clinical development, R&D operations, system governance, or data/process management within the pharmaceutical, biotech, or life sciences industry.
• At least 3 years of hands-on experience with Planisware or similar enterprise projects and portfolio management (PPM) systems.
• Proven experience leading process governance, change management, and data governance initiatives in a regulated (GxP/21 CFR Part 11) environment.
• Strong knowledge of Planisware functionality, including configuration, business process mapping, and system governance.
• Understanding of project and portfolio management (PPM) processes and tools, especially in clinical development and R&D environments.
• Experience with User Requirements Specifications (URS) development and version control processes.
• Familiarity with data governance principles, including master data management (MDM) and metadata standards.
• Proficiency in interpreting and applying data dictionaries, business rules, and standardized data definitions across systems.
• Working knowledge of change control processes, including functional change evaluation and documentation practices.
• Experience with system validation, including knowledge of compliance standards such as 21 CFR Part 11, GxP, and audit readiness.
• Competence in tools like JIRA, Confluence, or similar platforms for backlog, change tracking, and collaboration.

Nice to Have

• Advanced degree (e.g., MBA, MS, or related graduate degree).
• Certifications in Project Management, Lean Six Sigma, Change Management, or Data Governance.

Benefits & Perks

• 401K with company matching
• Discretionary Profit Sharing
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule including Summer and Winter Shut-Downs, Sick Days and Volunteer Days
• Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Long-Term Incentives
• Life & Disability Insurance
• Concierge Service
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards