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Karlin Karlmark

@karlinkarlmark

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I lead global clinical trials from start-up through close-out across regulated markets.

France

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What I'm looking for

I'm looking to lead global clinical trials in regulated pharmaceutical or biotechnology environments, with responsibility for study delivery, cross-functional teams, vendors, risk management, and quality-driven outcomes.

I led a multicenter global Phase IIb clinical trial for Sanofi across eight countries, from study start-up through database lock and draft clinical study report delivery. I managed global teams, vendors, budgets, contracts, risk plans, and regulatory and ethics submissions.

At Syneos Health, I managed early-phase clinical and biomarker R&D studies, overseeing timelines, resources, sponsor communication, site monitoring, vendor contracts, and financial closeout. My proactive risk mitigation reduced study delays by 25%, while targeted site training reduced protocol deviations by 15%.

My background also spans biochemistry, biotechnology, genomics, preclinical R&D, and clinical research platforms. I bring eight years of international clinical research experience across EU, US, Canada, LATAM, India, Japan, and Australia, working within FDA, EMA, ICH-GCP, and health-authority requirements.

Experience

Work history, roles, and key accomplishments

Trainee - Oncology Monitor (CRA)

Viares Academy & University of California, San Diego

Feb 2026 - May 2026 (3 months)

Completed clinical oncology monitoring training program, mastering safety reporting, tumor response evaluation, and data integrity compliance.

CTCAE V6.0 RECIST 1.1 RECIST GCP SDV E CRF Monitoring Visits

Global Clinical Study Operations Manager

Aixial Group

Mar 2023 - Nov 2025 (2 years 8 months)

Managed end-to-end project management for a multicenter global Phase IIb clinical trial for Sanofi, ensuring ICH-GCP compliance and achieving recruitment targets.

Clinical Trial Management ICH GCP Risk Management Vendor Management TMF CAPA Investigator Meetings AI DHT EConsent UAT

Project Manager - Early Phase Clinical

Syneos Health

Oct 2019 - Nov 2022 (3 years 1 month)

Managed early phase clinical trials and biomarker R&D studies, overseeing planning, execution, and vendor contracts.

Clinical Project Management Regulatory Submissions Risk Management Vendor Management CRO Oversight Budget Management

Senior Project Manager - Biochemistry & Biotechnology

Mars Global Services

Jun 2018 - Sep 2019 (1 year 3 months)

Managed projects under ISO standards, overseeing budgets, contracts, and vendor quality audits.

ISO 21500 ISO 17025 GMP Vendor Management Quality Audits Stakeholder Communication

Project Manager - Alternative Methods Unit

Mars Petcare - Royal Canin SAS

Mar 2016 - May 2018 (2 years 2 months)

Managed project planning, method development, and validation for R&D quality and food safety.

Project Planning Method Development Validation CAPA KPIs Budget Forecasting

Platform Manager

INSERM

Jan 2013 - Feb 2016 (3 years 1 month)

Managed a human genomics clinical research platform, ensuring data integrity and GCP compliance.

Genomics GCP Data Integrity Team Supervision

Post-Doctoral Fellow - Department of Dermatology & Allergology

Medical University of Marburg

Sep 2010 - Dec 2012 (2 years 3 months)

Worked on preclinical R&D and clinical projects on a rare autoimmune skin disease.

Preclinical Research Clinical Research Autoimmune Diseases

Post-Doctoral Fellow - Department of Internal Medicine

RWTH Medical University of Aachen

Dec 2009 - Aug 2010 (8 months)

Worked on projects related to liver inflammation and fibrosis.

Internal Medicine Liver Inflammation Fibrosis

Research Associate - Department of Molecular Cell Biology

DSM Biologics & University of Groningen

Jun 2005 - Jul 2006 (1 year 1 month)

Worked on projects related to industrial production of Penicillin antibiotics.

Cell and Molecular Biology Penicillin Production

Research Associate - Department of Pediatrics

AKH-Medical University of Vienna

Feb 2004 - May 2005 (1 year 3 months)

Worked on projects related to proteomics on prenatal diagnostics and amniotic stem cells.

Proteomics Prenatal Testing Stem Cells

Education

Degrees, certifications, and relevant coursework

Viares Academy & University of California, San Diego

Trainee - Oncology Monitor (CRA), Oncology

2026 - 2026

Completed clinical oncology monitoring training program, gaining knowledge in oncology clinical trial monitoring. Course covered safety reporting, tumor response evaluation, data integrity, and clinical reporting.