Medasource is seeking a Project Manager to lead the migration of regulated documents and data from newly acquired companies into the client’s core systems. The role involves coordinating with various stakeholders to ensure efficient and compliant data migrations in a fast-paced integration environment.
Responsibilities:
- Coordinate the migration of regulated documents and operational data from acquired companies’ source systems into the client’s internal platforms following acquisition announcements
- Facilitate planning for how, when, and where documentation should be transferred while minimizing disruption to ongoing clinical trials and development activities
- Ensure migration activities align with defined integration timelines and regulatory requirements
- Operate within a cross-functional matrix structure involving Clinical Operations, Regulatory Affairs, Safety, IT, and other core functions
- Partner with the ATT “Jump Team”, a group of subject matter experts from core functions responsible for acquisition integration
- Serve as a coordination point between ATT and drug development teams, helping align priorities for data and document migration
- Lead and facilitate internal meetings, document decisions, and track action items to ensure progress toward integration milestones
- Develop and maintain integration project plans, timelines, and dashboards (e.g., using Smartsheet or similar tools)
- Track migration progress and proactively identify risks, dependencies, and gaps across functions
- Drive prioritization discussions with development teams regarding which systems, datasets, or documents must be migrated first
- Provide meeting facilitation, documentation, and follow-through on action items to keep integration workstreams on track
- Prompt and guide stakeholders through required steps to ensure timely completion of migration activities
- Coordinate with vendors and CROs to facilitate transfer of clinical and safety data into client’s systems
- Advise functional partners on migration processes and potential risks related to system transitions or trial operations
- Ensure appropriate access and collaboration tools (e.g., SharePoint) are established and maintained for integration teams
Requirements:
- Bachelor's degree in Life Sciences, Clinical Research, Project Management, or a related field
- Demonstrated project management experience in pharma or biotech environments, particularly within clinical development or regulated data environments
- Experience working in cross-functional matrix organizations with multiple stakeholders and priorities
- Strong facilitation, organization, and communication skills with the ability to drive decisions and next steps
- Ability to work independently with minimal oversight and quickly establish structure in ambiguous or fast-moving environments
- Experience coordinating activities with external partners such as CROs or vendors
- Experience with clinical development systems:
- Clinical Trial Management Systems (CTMS)
- Regulatory information management or Regulatory Electronic Management (REM) systems
- Safety databases
- Statistical analysis or clinical data repositories
- Familiarity with Quality Management Systems (QMS) and Veeva platforms
- Experience supporting system migrations or data transfers regulated environments
- Proficiency with project management tools (Smartsheet, dashboards, integrated project plans)
- Understanding of clinical development processes, including trial sponsorship transfer and regulatory documentation management