Project Manager GxP​/Clinical Operations

About the Role

We are seeking a highly motivated Project Manager with extensive experience leading GxP-compliant projects, ideally within Clinical Operations. This role requires strong leadership, organization, and communication skills to effectively manage multiple work streams, budgets, stakeholders, and vendors in a regulated environment.

Location: Remote (Must work East Coast Time Zone hours)
Job Type: Long term contract
Industry: Pharmaceutical / Life Sciences / Clinical Research

• Lead and manage multiple GxP-compliant projects from initiation through closure, ensuring on-time and high-quality delivery.

• Collaborate with cross-functional teams (business and technical) to gather and document requirements.

• Develop and maintain project plans, timelines, and risk mitigation strategies.

• Oversee vendor selection, qualification, and management, ensuring alignment with compliance standards and project goals.

• Manage project budgets, track expenses, and provide regular financial updates to leadership.

• Ensure GxP compliance throughout the project lifecycle in accordance with company policies and regulatory standards.

• Prepare and deliver project status reports to stakeholders, leadership, and steering committees.

• Facilitate key meetings including stakeholder workshops, project reviews, and alignment sessions.

• Coordinate resources across multiple projects or small programs, ensuring effective prioritization and delivery.

• Identify and mitigate project risks, proactively resolving issues as they arise.

• Apply best practices in both Agile and Waterfall project methodologies.

• Demonstrate flexibility and step into additional responsibilities as needed to support project success.

• Strong understanding of clinical trial management processes and experience managing both business and technology work streams.

• Proven experience delivering GxP-compliant projects in a regulated environment.

• Excellent organizational, time management, and problem-solving skills.

• Proven ability to manage multiple projects simultaneously with attention to detail and prioritization.

• Exceptional communication and interpersonal skills to engage with stakeholders at all levels.

• Proficiency in project management tools (e.g., Microsoft Project, Smartsheet).

• Hands-on experience with Agile (Scrum) tools including JIRA, Confluence, and QTest.

• Familiarity with GxP-compliant systems, validation practices, and electronic documentation.

• Understanding of the Software Development Life Cycle (SDLC) and change control processes.

• GxP / Pharma Experience: Required

• Project Methodology: Agile & Waterfall

• Work Hours: Must be available to work in Eastern Time Zone

• Location: Remote

If you’re a detail-oriented, proactive Project Manager with a passion for life sciences and regulatory compliance, we encourage you to apply on

Benefits:
We offer a competitive compensation package that includes:

• Pay Rate: $70 - $90 per Hour
  • 
    
    Note:
    
    Pay rate will be commensurate with experience.
• Medical for full time employees
• Dental, and Vision Insurance
• Life Insurance, Short-Term Disability, Long-Term Disability, etc.

Thank you
Anupma Pathak