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Sophia Anastassova

@sophiaanastassova

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Experienced clinical research professional specializing in global trials, regulatory compliance and pharmacovigilance.

Switzerland

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What I'm looking for

I am seeking a remote or hybrid clinical operations role where I can lead global study start-up, regulatory compliance and pharmacovigilance efforts, mentor teams, and drive high-quality trial delivery.

I am a seasoned clinical research and regulatory compliance specialist with extensive experience supporting global drug safety, study start-up, and trial management for large pharmaceutical sponsors and CROs.

Over more than two decades I have coordinated and managed Phase 2–4 trials, supported global site activation for hundreds of sites, maintained eTMF/CTMS systems, and overseen safety reporting and submissions.

My strengths include regulatory submissions, pharmacovigilance case handling, vendor and supply management, data quality oversight, and mentoring cross-functional study teams in matrix environments.

I bring a detail-oriented, compliance-driven approach, strong communication skills, multilingual capability, and a track record of identifying risks, implementing mitigations, and delivering high-quality results for complex, global clinical programs.

Experience

Work history, roles, and key accomplishments

Current

Lead Global Trials Specialist

Current

Celgene International Sarl

Aug 2017 - Present (8 years 2 months)

Lead Global Trials Specialist supporting study start-up, site selection, supply and vendor management, eTMF/Veeva Vault administration, and data cleanliness to drive on-time study execution for global clinical trials.

Study Start Up Rave Regulatory Submissions Vendor Management Clinical Supply Risk Mitigation

Global Regulatory Compliance Lead

Worldwide Clinical Trials Ltd.

May 2011 - Aug 2017 (6 years 3 months)

Global Regulatory Compliance Lead managing site start-up essential document collection, eTMF/e-TMF compliance checks, and training to prepare 300+ sites for initiation across global clinical programs.

Regulatory Submissions ETMF Pharmacovigilance (ARGUS)CTMS Quality Control SOP GWP

Clinical Trial Coordinator

Novartis Pharma Services

Jun 2010 - May 2011 (11 months)

Clinical Trial Coordinator supporting setup and conduct of Phase 2–3 trials with responsibilities in TMF management, regulatory assistance, site management, and quality/compliance checks.

TMF Site management Regulatory ICH GCP CRF Tracking Quality Control

Sr. Regulatory Submissions Specialist

Pfizer Inc.

Jan 2010 - Jun 2010 (5 months)

Senior Regulatory Submissions Specialist coordinating regulatory dossier preparation and TMF activities for ~16 Phase 2–3 oncology trials, ensuring timely submissions and eTMF quality.

Regulatory Submissions TMF Contract Drafting QA

In-house Clinical Research Associate

Premier Research Group Limited

Mar 2008 - Dec 2009 (1 year 9 months)

In-house CRA supporting Phase 2–3 trials with monitoring support, TMF preparation, safety reporting, drug accountability and regulatory document submission across multiple sites.

Monitoring TMF Pharmacovigilance Regulatory Submissions Drug Accountability

Project Coordinator

PSI Pharma Support Intl.

Nov 2003 - Feb 2008 (4 years 3 months)

Project Coordinator for Phase 2–3 clinical trials overseeing TMF maintenance, regulatory package preparation, safety submissions and coordination of site activities to support study delivery.

TMF SAE SUSAR Reporting Project Coordination