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I’m Marilena Katsa, a Clinical Data Operations Manager specializing in AI-enabled clinical trials within oncology and immunology. I lead cross-functional teams, optimize workflows, and ensure regulatory compliance to scale data operations with precision and speed. I’ve driven data accuracy above 99% and achieved tangible efficiency gains through SOP optimization and SaaS workflow enhancements. I combine scientific rigor with an entrepreneurial mindset to deliver scalable, compliant clinical data programs aligned with ICH-GCP guidelines. I’m passionate about building high-performing teams, mentoring talent, and partnering with product and engineering to remove bottlenecks and boost trial success. My goal is to continue shaping AI-enabled data operations that accelerate insights while upholding the highest standards of quality and patient safety.…I’m Marilena Katsa, a Clinical Data Operations Manager specializing in AI-enabled clinical trials within oncology and immunology. I lead cross-functional teams, optimize workflows, and ensure regulatory compliance to scale data operations with precision and speed. I’ve driven data accuracy above 99% and achieved tangible efficiency gains through SOP optimization and SaaS workflow enhancements. I combine scientific rigor with an entrepreneurial mindset to deliver scalable, compliant clinical data programs aligned with ICH-GCP guidelines. I’m passionate about building high-performing teams, mentoring talent, and partnering with product and engineering to remove bottlenecks and boost trial success. My goal is to continue shaping AI-enabled data operations that accelerate insights while upholding the highest standards of quality and patient safety.

Marilena Katsa

Data Scientist, Project Manager, AI Engineer, +2

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I’m Marilena Katsa, a Clinical Data Operations Manager specializing in AI-enabled clinical trials within oncology and immunology. I lead cross-functional teams, optimize workflows, and ensure regulatory compliance to scale data operations with precision and speed. I’ve driven data accuracy above 99% and achieved tangible efficiency gains through SOP optimization and SaaS workflow enhancements. I combine scientific rigor with an entrepreneurial mindset to deliver scalable, compliant clinical data programs aligned with ICH-GCP guidelines. I’m passionate about building high-performing teams, mentoring talent, and partnering with product and engineering to remove bottlenecks and boost trial success. My goal is to continue shaping AI-enabled data operations that accelerate insights while upholding the highest standards of quality and patient safety.…I’m Marilena Katsa, a Clinical Data Operations Manager specializing in AI-enabled clinical trials within oncology and immunology. I lead cross-functional teams, optimize workflows, and ensure regulatory compliance to scale data operations with precision and speed. I’ve driven data accuracy above 99% and achieved tangible efficiency gains through SOP optimization and SaaS workflow enhancements. I combine scientific rigor with an entrepreneurial mindset to deliver scalable, compliant clinical data programs aligned with ICH-GCP guidelines. I’m passionate about building high-performing teams, mentoring talent, and partnering with product and engineering to remove bottlenecks and boost trial success. My goal is to continue shaping AI-enabled data operations that accelerate insights while upholding the highest standards of quality and patient safety.

Available to hire

I’m Marilena Katsa, a Clinical Data Operations Manager specializing in AI-enabled clinical trials within oncology and immunology. I lead cross-functional teams, optimize workflows, and ensure regulatory compliance to scale data operations with precision and speed. I’ve driven data accuracy above 99% and achieved tangible efficiency gains through SOP optimization and SaaS workflow enhancements. I combine scientific rigor with an entrepreneurial mindset to deliver scalable, compliant clinical data programs aligned with ICH-GCP guidelines.

I’m passionate about building high-performing teams, mentoring talent, and partnering with product and engineering to remove bottlenecks and boost trial success. My goal is to continue shaping AI-enabled data operations that accelerate insights while upholding the highest standards of quality and patient safety.

Skills

Experience Level

Expert

Expert

Expert

Expert

Intermediate

Intermediate

Intermediate

Intermediate

Language

Greek, Modern

Fluent

English

Advanced

French

Intermediate

Work Experience

Scientific Manager, Clinical Data at Intelligencia.ai

April 1, 2022 - April 1, 2025

Scientific leadership: Managed 2 data teams (14 Scientific Associates) across oncology and immunology clinical data workflows. Oversaw projects from capacity planning to execution, driving a 30% improvement in curation efficiency through root-cause analysis and workflow redesign. Strategic Operations: Represented CDE in forecasting, resource allocation, and risk assessments, ensuring alignment with growth targets. Innovation & Process Optimization: Partnered with Product and Engineering to streamline workflows, integrate SaaS platform enhancements, eliminate bottlenecks and improve scalability. Onboarding & Capability Development: Led a 3-member onboarding team, reducing new-hire ramp-up time by 50% and onboarding 36+ employees with promotions of 8 associates. Documentation & Compliance: Oversaw SOPs and trial process documentation, ensuring GCP/ICH/FDA/EMA compliance. Recruitment & Talent Development: Collaborated with HR to strengthen talent quality and foster accountability and coll

Scientific Associate, Clinical Data at Intelligencia.ai

October 1, 2019 - April 1, 2022

Delivered high-quality clinical data curation (>99%) for oncology and immunology trials, ensuring strict adherence to SOPs and regulatory standards. Collaborated across scientific and operational teams, provided peer mentorship and onboarding support. Identified process inefficiencies and co-designed enhancements that improved accuracy and reduced turnaround time. Maintained SOPs and internal guidance for regulatory adherence.

Co-Owner at Giasemi

August 1, 2022 - Present

Oversee guesthouse operations on Aegina Island, including bookings, guest communication, cleaning coordination, maintenance, and delivering excellent customer service.

Co-Founder at Meleonas Honey

December 1, 2022 - Present

Beekeeping and honey production on Aegina Island, packaging, social media, and sales.