Phlex eTMF implementation

Advanced Bio-Logic Solutions Corp•San Francisco, CA

3d•Remote

About The Position

We are seeking a hands-on Business Analyst and Project Manager to support the implementation and optimization of the Phlex eTMF platform. This part-time resource will coordinate implementation activities, gather and document requirements, improve business processes, manage project tracking, and support users throughout the implementation. The ideal candidate has experience supporting eTMF or other clinical technology implementations and is comfortable working independently across business, clinical, technical, and vendor teams.

Requirements

Experience working as a Business Analyst, Project Manager, or combined BA/PM resource.
Experience supporting an eTMF implementation or another clinical technology platform.
Familiarity with Phlex eTMF is strongly preferred.
Experience gathering requirements and documenting business processes and workflows.
Strong project coordination, organization, and follow-up skills.
Experience using Smartsheet for project planning, tracking, dashboards, or reporting.
Experience coordinating user provisioning and system access.
Proficiency with Microsoft OneNote for project documentation and collaboration.
Familiarity with SAS-related processes or systems.
Ability to identify process gaps and recommend practical improvements.
Strong written and verbal communication skills.
Ability to work independently within a flexible, part-time schedule.
Experience in a life sciences, clinical, biotechnology, or regulated environment is preferred.

Nice To Haves

Familiarity with Phlex eTMF is strongly preferred.
Experience in a life sciences, clinical, biotechnology, or regulated environment is preferred.

Responsibilities

Support the planning, coordination, and execution of the Phlex eTMF implementation.
Gather, document, validate, and communicate business and system requirements.
Translate business needs into project activities, deliverables, and timelines.
Review current processes and recommend practical workflow improvements.
Maintain project plans, dashboards, action items, risks, issues, and status reports in Smartsheet.
Coordinate user provisioning, access requests, role assignments, and related documentation.
Maintain meeting notes, decisions, requirements, and project documentation in Microsoft OneNote.
Support SAS-related processes and project activities.
Coordinate meetings and follow-up activities across internal teams and external vendors.
Track implementation dependencies, risks, decisions, and outstanding action items.
Support user readiness, communications, and implementation activities.
Provide clear and timely updates to project stakeholders.
Coordinate Phlex eTMF implementation meetings and follow-up activities.
Gather requirements and document workflows, decisions, and action items.
Update project schedules, dashboards, risks, and issue trackers in Smartsheet.
Work with stakeholders to identify and implement process improvements.
Coordinate new-user access, system roles, and provisioning requests.
Maintain organized project documentation in Microsoft OneNote.
Support SAS-related project needs.
Communicate progress, risks, dependencies, and next steps to stakeholders.