PHARMA background (NOT healthcare)

NEED to go onsite 2 days a week in Cambridge, MA (no exceptions)

Would be open to hands on Business Analyst as well

7-10 years' experience inj project management in a GxP environment

Proven experience with numerous Clinical Informatics, Lab applications and Lab Automation

Working knowledge of CSV concepts for SaaS GxP applications

***they need a true PM, someone who has worked with internal stakeholders or vendors, someone who can set up a project plan from ground zero. They have a lot of diff projects going on, so they need someone who knows how to deploy a project, figure out what it needs to move forward. Think true hands on PM***

Project Manager/Business Analyst

As a Project Manager, you will be spearheading the execution of critical projects in support of ambitious clinical digital roadmap. In this role, you will connect and lead various stakeholders and contributors to collaborate on digital clinical projects.

Here’s What You’ll Do:

• Define and lead Digital Clinical Biomarker projects
• Coordinate and participate in requirement gathering and definition (Business Analysis)
• Establish Project Charter and manage project timelines and project deliverable
• Ensure project goals and means meet business objectives and deliver value in a timely fashion
• Work collaboratively across the organization to gain alignment on project objectives and deliverables
• Engage with Computer Systems Validation lead to support appropriate validation activities
• Report on project progress and status

Here’s What You’ll Bring to the Table:

• 7-10 years' experience in digital project management in a GxP environment
• Proven experience with numerous Clinical Informatics, Lab applications and Lab Automation
• Working knowledge of CSV concepts for SaaS GxP applications
• Tangible track record in using Agile approaches in a regulated environment
• As a technologist, you know your craft and, you are fluent in the digital world. You have first-hand knowledge of SaaS technology in a GxP environment and practical understanding of data integrity requirements for systems used in the conduct of clinical trials.
• You have a working knowledge of clinical operations, clinical lab systems and regulatory in a drug development context
• You work independently yet engage proactively with team members, colleagues and stakeholders to get alignment and drive projects forward.
• You don't hesitate to dive in and work alongside your team. You can effectively manage conflicting priorities in a fast pace environment, and you can navigate ambiguity and lead a team effectively
• You put team before tasks by collaborating actively with all team members and supporting them.
• Bachelor's degree in Computer Science, Biotechnology or equivalent required. Master's preferred.