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 workstreams, 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 workstreams.
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
apathak@alphambe.com
Thank you
Anupma Pathak