Education
Hospitals and Health Care
Active

Tomasz Szelag

Clinical Operations, Clinical Development, Clinical Data Management

About Me

Accomplished clinical operations executive with over 20 years of experience in global pharmaceutical and biotechnology industries. Skilled in building and scaling organizations, leading cross-functional teams, and managing complex clinical development programs. Proven expertise in regulatory compliance, vendor and CRO management, and data-driven process optimization. Experienced in oncology research and clinical trial oversight across Central and Eastern Europe, with a strong record of collaboration with global regulatory authorities, investigators, and executive leadership. Certified Professional Scrum Master and university lecturer, passionate about advancing clinical research, patient advocacy, and leadership development in life sciences.

Jurisdiction

Poland | Austria | Belgium | Bulgaria | Canada | Croatia | Cyprus | Czech Republic | Denmark | Estonia | Finland | France | Germany | Georgia | Hungary | Iceland | Ireland | Italy | Latvia | Lithuania | Luxembourg | Moldova | Netherlands | North Macedonia | Norway | Portugal | Romania | Serbia | Slovakia | Slovenia | Spain | Sweden | Switzerland | Ukraine | United States

Notable Employer

  • Head of Clinical Operations at Ryvu Therapeutics
  • Lecturer & External Stakeholders Council Member at Warsaw University of Life Sciences
  • Clinical Operations Leader at Roche
  • Associate Director Clinical Data Review, Global Data Management at Bristol-Myers Squibb
  • Clinical Operations Manager, Site & Clinical Data Quality Management at Bristol-Myers Squibb
  • Clinical Trial Manager at Bristol-Myers Squibb

Experience

Seniority LevelExecutive
Years of Experience20+ years
Current StatusActive
Head of Clinical OperationsNotable
2022 - Present

• Building and managing the clinical operations department • Managing functions like Regulatory, Clinical Finance, Data Management, Site Management and Monitoring, Project Management, Vendor Management, Supply Chain • Effectively scaling up the organization • Budget management and oversight (≈ 60M $) • Acting as program director supporting compound development • Creating SOPs, processes, policies, and working instruction • Interacting with investigators, advocacy groups, and regulators (FDA, EMA), • Very close collaboration with CMO, COO and CEO

Lecturer & External Stakeholders Council MemberNotable
2022 - Present

Lectures about GCP and clinical trials management for Biology, Biotechnology, Medical Technology and postgraduate students • Consultancy in the field of cooperation with business

Director, Study Management
2021 - 2022

• Study Management Leadership team core member • Line management to the team covering a global portfolio operationalization • Operational Management across Study Management

Clinical Operations LeaderNotable
2018 - 2021

leadership and oversight in the delivery of oncology clinical trials in the CEE region (Bosnia, Croatia, Czech Rep., Estonia, Hungary, Latvia, Lithuania, Poland, Romania, Serbia, Slovakia, Slovenia) line managing groups of Clinical Study Managers and Clinical Country Specialist • member of the Regional Leadership Team responsible for building a strategy, managing the whole organization, implementing the goals, improving risk management, and effective decision-making

Associate Director Clinical Data Review, Global Data ManagementNotable
2017 - 2018

building the Clinical Data Review department, shaping the organization, recruiting, and hiring • leading organizations including setting up and monitoring objectives • line managing a group of Clinical Data Reviewers and Lead Clinical Data Reviewers • transforming, optimizing, and simplifying processes in data review (less manual work, more well-programed edit checks, smart listings) • Led global transformational task forces and initiatives like Optimizing Medical Data Review and transformation of clinical data management into a centralized data review model • vendor liaison for clinical data management and clinical trials management

Clinical Operations Manager, Site & Clinical Data Quality ManagementNotable
2013 - 2017

development of projects execution strategies and studies deployment solutions in a Central and Eastern Europe region • leadership and oversight in the delivery of clinical trials in the CEET region (Czech Rep., Estonia, Georgia, Hungary, Latvia, Lithuania, Moldova, Poland, Romania, Russia, and Turkey) • line managing a group of Clinical Site Managers and Clinical Data Quality Managers • vendor oversight and partnership (CRO, phase I units, SMOs, Functional Service Providers) • building a Clinical Site Monitoring team in Hungary

Clinical Trial ManagerNotable
2007 - 2013

• execution of clinical trials in Central and Eastern Europe • project management and coordination of clinical trials activities • monitoring budget and study payment • CRO oversight • CTMS global expert and trainer

Education

Diploma of Finance Management, Post-GraduateWroclaw University of Economics
Present
Diploma of Operational Management, Post-GraduatePolish Open University
Present
Diploma of Medical Law, Law of Bioethics, Post-GraduateWarsaw University
Present
Degree of DatabasesComputer Science College in Warsaw
Present
Masters of Genetics and BiotechnologyWarsaw University of Life Science
Present

Certification

Total Certifications1

ICH GCP R3

Skills

Core skills9
Languages2

Skills

clinical operations
CTSM
clinical data review
Scaling Up
budget and finance
Clinical Operations Leadership
Regulatory & Compliance Expertise
Vendor & CRO Management
Strategic Project & Program Management

Languages

English
Polish

Services