Ed Potero

About Ed Potero

I am a driven Project Management professional with extensive and diversified experience across therapeutic areas and Health Outcome Research modalities. I have demonstrated leadership in coordinating and leading multiple system launches and enhancements enterprise-wide. I utilize excellent communication, problem solving, and team building skills that influence cross-functional teams and harmonized new business lines to grow the organization, as well as improve customer service and quality outcomes. As Director, I have recruited top talent to support new business and increase bottom line or revenue.

Experience

1. Associate Director, Eclinical Implementation - Clinical Data Management

   Biogen

   Apr 2022 — Present · Cambridge, MA, US

   accountable for the performance and results in this space and line management of associated FTE and/or FSP staff and vendor teams.* collaborate with internal Biogen stakeholders and external vendors teams in the vendor selection, implementation strategy, and business plan development related to leveraging eClinical and sensor data through the portfolio.* interpret internal/external business challenges and recommend best practices to improve products, processes, or services.* Engages external industry experts and evolving technologies assessing risk/benefit for potential implementation into future portfolio studies.* Develop cross-functional processes, industry best practices and drive organizational learning to ensure consistent adoption of eClinical technology with a focus on cost and operational efficiency, quality, data integrity, and user (site/patient) experience.* Responsible for Biogen Portfolio level eClinical assessments planning and for providing a framework for Program/Study level planning to ensure robust data quality and compliance with regulatory requirements including regulatory submissions.* Provides process and guidance to program and study teams (insourced and outsourced) on eClinical implementation.* Creates and maintains Communication Framework (stakeholder engagement) for information sharing/training, feedback for continuous improvement with stakeholders on Program and Study level, and maintaining SOPs.* Drive cross functional collaboration to develop best practice and functional accountability to influence leadership to adopt eClinical assessment technologies at a controlled pace ensuring process and quality measures are implemented in parallel.* Works with preferred vendors to drive standardization of documents, training and processes. Develop and monitor performance and quality metrics and compliance with agreed turnaround times with Vendors. Acts as escalation point for operational performance with Contracts Group.

Education

• Temple University

  BS, Exercise Science and Leadership

  1990 — 1993

• East Stroudsburg University of Pennsylvania

  MS, Cardiac Rehabilitation and Exercise Science

  1993 — 1994

Skills

• Communication
• Cross-Functional Team Leadership
• Software Documentation
• Sdlc
• Edc
• Therapeutic Areas
• Ctms
• Regulatory Affairs
• Lifesciences
• Process Improvement
• Dedicated Professional
• Management
• Clinical Development
• Onboarding
• Leadership
• Cross Functional Team Building
• Organization & Prioritization Skills
• Clinical Data Management
• Employee Training
• Oncology
• Protocol
• Forecasting
• CRO
• Project Management
• Change Management
• Clinical Trials
• Staff Development
• Cross-Functional Problem Solving
• Medical Devices
• Clinical Research
• Hiring Personnel
• Staff Management
• Cross-Functional Initiatives
• Pharmaceutical Industry
• Sop
• Fda
• Validation
• Cross-Functional Coordination
• Quality Assurance
• Team-Oriented