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I am a results-driven project leader with 10+ years of experience managing large, complex global programs in pharma and biotech, coordinating cross-functional teams across Europe, Asia, and the Americas. I excel at translating clinical and manufacturing objectives into actionable plans and fostering clear communication between engineers, scientists, and stakeholders in clinical operations, medical affairs, and manufacturing technology initiatives. I thrive in fast-paced environments that demand quality, timeliness, and regulatory compliance (ICH-GCP). I enjoy mentoring teams, driving process improvements, and delivering high-impact trial outcomes. Outside work, I stay active, enjoy nature, reading, learning, and meditation.…I am a results-driven project leader with 10+ years of experience managing large, complex global programs in pharma and biotech, coordinating cross-functional teams across Europe, Asia, and the Americas. I excel at translating clinical and manufacturing objectives into actionable plans and fostering clear communication between engineers, scientists, and stakeholders in clinical operations, medical affairs, and manufacturing technology initiatives. I thrive in fast-paced environments that demand quality, timeliness, and regulatory compliance (ICH-GCP). I enjoy mentoring teams, driving process improvements, and delivering high-impact trial outcomes. Outside work, I stay active, enjoy nature, reading, learning, and meditation.

Zane Zaleska

Project Manager, Production Manager, Content Producer, +2

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I am a results-driven project leader with 10+ years of experience managing large, complex global programs in pharma and biotech, coordinating cross-functional teams across Europe, Asia, and the Americas. I excel at translating clinical and manufacturing objectives into actionable plans and fostering clear communication between engineers, scientists, and stakeholders in clinical operations, medical affairs, and manufacturing technology initiatives. I thrive in fast-paced environments that demand quality, timeliness, and regulatory compliance (ICH-GCP). I enjoy mentoring teams, driving process improvements, and delivering high-impact trial outcomes. Outside work, I stay active, enjoy nature, reading, learning, and meditation.…I am a results-driven project leader with 10+ years of experience managing large, complex global programs in pharma and biotech, coordinating cross-functional teams across Europe, Asia, and the Americas. I excel at translating clinical and manufacturing objectives into actionable plans and fostering clear communication between engineers, scientists, and stakeholders in clinical operations, medical affairs, and manufacturing technology initiatives. I thrive in fast-paced environments that demand quality, timeliness, and regulatory compliance (ICH-GCP). I enjoy mentoring teams, driving process improvements, and delivering high-impact trial outcomes. Outside work, I stay active, enjoy nature, reading, learning, and meditation.

Available to hire

I am a results-driven project leader with 10+ years of experience managing large, complex global programs in pharma and biotech, coordinating cross-functional teams across Europe, Asia, and the Americas. I excel at translating clinical and manufacturing objectives into actionable plans and fostering clear communication between engineers, scientists, and stakeholders in clinical operations, medical affairs, and manufacturing technology initiatives.

I thrive in fast-paced environments that demand quality, timeliness, and regulatory compliance (ICH-GCP). I enjoy mentoring teams, driving process improvements, and delivering high-impact trial outcomes. Outside work, I stay active, enjoy nature, reading, learning, and meditation.

Language

English

Fluent

German

Fluent

Latvian

Fluent

Russian

Beginner

Work Experience

Senior Clinical Trial Manager at SixPeaks Bio

May 1, 2025 - Present

Day-to-day operations and oversight of a clinical trial set-up to ensure high quality deliverables, adherence with timelines, budget and compliance with ICH-GCP guidelines and SOPs. Co-leading the set-up of First-in-Human Phase I clinical trial in metabolic disease area. Management, oversight and monitoring of CRO and ESP deliverables and performance. Development of trial-specific plans, timelines, risk management and quality plans. Trial Master File oversight for audit/inspection readiness. Drug supply co-forecasting with CMC team. Study-related meetings leadership. Cross-functional alignment among clinical, pre-clinical, quality, CMC, vendors.

Group Fitness Instructor at ProSenectute

December 1, 2024 - Present

English and Science Teacher for Secondary Levels at Sandgruben

February 1, 2025 - May 31, 2025

Global Project Manager at Roche

April 1, 2020 - April 30, 2023

Development and maintenance of comprehensive project plans, including budgets and timelines to ensure successful completion of deliverables for priority technology initiatives, projects and programs. Leading large project meetings, preparation of agendas, minutes, action items. Management of project data. Stakeholder management and analysis. Communication of project plans to leadership in a cGMP environment. Key projects included offgas-based pH reference method in Drug Substance and piloting of glove-less robotic isolators / modular fillers in Drug Product networks.

Global Trial Manager at Johnson & Johnson (Janssen Medical Affairs Operations)

March 1, 2017 - December 31, 2019

Global trial management and leadership of Ph. IIIb and IV clinical trials, including set-up, conduct, close-out and regulatory submissions. Management of CROs, budgets, risks and timelines. Preparation of health authority, ethics committees, supplier and pharmaceutical company inspections. Conduct of on-site reviews and audits of clinical trial documentation (p/eTMF) at CROs.

Biomarker Operations Project Manager at Roche

January 1, 2011 - August 31, 2016

Biomarker operations project and vendor management for PoC, IND-enabling and Ph Ib-III oncology clinical trials (HER2 therapies, cancer immunotherapy, hemophilia). Development and delivery of training in biomarker activities to junior staff and site personnel at investigator meetings globally. Subject matter expert of biomarker operations in cross-functional teams for business process analysis, optimization and SOP development.

Clinical Logistics Manager at Novartis

February 1, 2009 - December 31, 2010

Coordination and shipment of clinical and biological samples. Processing of biological samples in the laboratory. Development of blood donor databank and biological fluid banks.