Clinical Trial Project Manager

We are seeking an experienced Clinical Trial Project Manager to join our Operations team. Reporting to the Vice President of Operations, you will be responsible for managing and overseeing Paradigm Health’s contracted clinical trials from inception to completion, ensuring that all projects are completed on time, within budget, and in compliance with all regulatory requirements. You will coordinate with cross-functional teams and–in partnership with the VP of Operations and other Sponsor Success Managers–serve as a key contact for study sponsors, clinical research organizations, and other stakeholders regarding the status of their sponsored trials. This role requires an individual with exceptional organizational and communication skills. You will be responsible for establishing standard project management templates and processes and work with cross functional stakeholders to align to those processes. As projects unfold, you will be accountable for tracking project progress and KPIs, identifying potential or emerging blockers, coordinating with the key resources within Paradigm Health and client organizations needed to unblock progress, and communicating seamlessly with internal and external stakeholders alike. This role requires someone with a strong track record of successfully driving complex, cross functional projects to successful outcomes (not just completion).

What you’ll do:

Coordinate Execution of Sponsored Trials: 

• Plan, initiate, lead, and manage clinical trials in partnership with a cross functional set of service delivery teams. 
• Develop comprehensive project plans outlining timelines, budgets, resources, and deliverables.  
• Define accurate milestones, timelines, and budget management for projects to ensure delivery against internal goals
• Oversee site selection, initiation, and patient recruitment deliverables. Ensure sites are adequately trained and resourced to conduct trials in compliance with protocols.

Regulatory Compliance: 

• Work closely with Compliance Team to ensure all clinical trials are compliant with regulatory agencies, Good Clinical Practice (GCP) guidelines, and company SOPs. 
• Update guidelines and company SOPs as needed
• Prepare for and participate in regulatory audits and inspections as needed

Communication: 

• Serve as a primary point of contact between sponsors and internal teams in partnership with Sponsor Success Managers. Provide regular updates and progress reports to external and internal stakeholders.  

Support of Sales: 

• Develop strong relationships with current clients to generate new and/or additional business in the future
• Liaise with Sales Team about potential new opportunities and facilitate appropriate introductions to client contacts
• Participate in proposals about potential study opportunities and speak as a domain expert in operationalizing the Paradigm platform in context of clinical trials.

Operational Excellence:

• Establish and maintain best practices for project management, quality assurance, and performance metrics for trials and overall team performance
• Utilize learnings from trial execution to identify opportunities to improve our service delivery model and develop recommendations to address
• Initiate continuous improvement efforts to address
• Drive continuous improvement efforts to enhance operational efficiency, productivity, and customer satisfaction long-term vision

Who you are:

• BA/BS degree with equivalent work experience preferred
• 3+ years in a client-facing role and track record of managing relationships with high-level enterprise clients. 
• Clinical research organization (CRO)/Pharmaceutical and relevant therapeutic experience preferred. 
• Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements
• Exceptional project and program management skills:
• Strong track record of simultaneously leading complex, multi-faceted projects to successful completion
• Experience utilizing broad range of project management tools and techniques to effectively assign, monitor, and unblock key tasks
• Proactive problem solver and driver of work–i.e., not focused just on taking notes and checking boxes
• Ability to communicate clearly and concisely across technology, business, and clinical teams, both a peer and senior level
• Deep comfort with data and reporting systems utilized in tracking project progress–e.g., Databricks, Looker, Tableau
• Deep understanding of digital health technologies utilized by both pharmaceutical and provider sectors
• Ability to maintain strict confidentiality a must
• Previous clinical trial research experience (e.g., within biopharmaceutical or provider organization) a strong plus