Robert Wroblewski Email & Phone Number

• Proactively manage project level operational aspects of Clinical Research Team (CRT) including management of trial timeline, budget, resources, and vendors.• Provide efficient updates on trial progress to the Clinical Program Manager (CPM) and/or Chief Technology Officer, with respect to vendor selection, project plans, trial budget and timeline management, quality standards and risk mitigation.• Lead sponsor study startup process, including but not limited to conduct of the Trial Kick-off meeting, the set-up of trial master file (TMF), site selection and finalization of site and vendor Clinical Trial Agreements and budgets.• Ensure effective project plans are in place and operational for each trial and work proactively with the Clinical Research Team (CRT) to set priorities in accordance with applicable project plans, company standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements.

Lakeville, Minnesota, United States

Effectively organize and coordinated players to improve skills, mindsets, and knowledge.✓ Creates and executes practice and game plans to develop player skill and knowledge✓ Relays information in multiple ways to individuals and groups to ensure understanding and retention✓ Assesses player knowledge and abilities to uncover flaws and correct faults

United States

Clinical Portfolio and Project Management - Built opportunity pipelines, identified service prospects, managed programs, and heavily contributed to business and account development to introduce the Core Clinical Solutions/Internal CRO service capabilities to Operating Unit stakeholders.✓ Led the operationalization of service delivery and service design by improving proposal creation, presentations to partners, and connecting with functional SMEs to develop innovative solutions for service planning.✓ Developed and managed strategic collaboration initiatives to strengthen internal partnerships.✓ Helped resolve a director-partner conflict and developed a strong partnership by facilitating communication and integrating diverse perspectives into an action plan, and presenting risk mitigation strategies while securing buy-ins on both teams.✓ Worked with stakeholders to analyze concerns and address root causes, transformed communications from reactive to proactive, and helped communicate value and overcome the negative perception of specific internal functions to drive collaboration.

United States

Clinical Project & Trial Management | Clinical Site Development - Developed and executed clinical strategies to assess and increase the performance of the ongoing evaluation of product safety and effectiveness following market release and next-generation device for premarket approval (PMA).✓ Collected and integrated clinical data to generate insightful and actionable reports and recommendations.✓ Managed multiple projects with a focus on meeting federal regulatory requirements, expediting timelines for deliverables, and coordinating activities with clinical affiliates.

Mounds View, Mn

Clinical Project & Trial Management | Clinical Site Development, Management, and Monitoring - Served as the Subject Matter Expert for diverse stakeholders to drive center performance and foster strong customer relationships.✓ Spearheaded research programs to build relationships with KOLs, PIs, and other parties, consult with underperforming sites to identify and mitigate root causes, and develop new research sites.✓ Oversaw the studies and collaborated within cross-functional teams to ensure project deliverables, including contracting, budget negotiations, site activation, data collection, site/study closure, etc.✓ Performed data review and oversight and resolved monitoring action items.✓ Developed and implemented new protocols while promoting the latest methodologies and industry best practices compliant with global regulations.

Bloomington, Mn

Organized and coordinated clinical research studies while building relationships as the primary patient contact.✓ Effectively managed multiple studies while following FDA, ICH, and GCP protocols, rules, and regulations to ensure compliance.✓ Trained Investigators, technicians, and new team members on clinical protocols and techniques to increase team performance.✓ Gathered, entered, processed, and analyzed complex study data using the latest data analytics tools and technologies.