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Emmanouil Volikos

@emmanouilvolikos

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Results-oriented leader with 10+ years in pharmaceutical project management.

Greece

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What I'm looking for

I am looking for a role that fosters collaboration, innovation, and growth opportunities in the pharmaceutical sector.

I am a results-oriented leader with over 10 years of experience in the pharmaceutical and life sciences industry. My expertise lies in project management, client engagement, and regulatory affairs, where I have consistently delivered complex projects on time and within budget. I am passionate about leveraging data and technology to accelerate drug development and improve patient outcomes.

Throughout my career, I have successfully managed cross-functional teams and built strong relationships with internal and external stakeholders. My role as a Project Manager at Accelsiors has allowed me to lead teams in delivering clinical trials that exceed client expectations. I have a proven track record in regulatory compliance and strategic planning, ensuring that all project deliverables meet the highest standards.

Experience

Work history, roles, and key accomplishments

Current

Project Manager - Clinical Team Manager

Current

Accelsiors

Jul 2022 - Present (3 years)

Led cross-functional teams of 10+ members to deliver complex clinical trials on time and within budget, consistently exceeding client expectations. As the primary owner of all project deliverables, prepared project plans and ensured timelines were met.

Project Management Clinical Trials Team Leadership Client Engagement Regulatory Affairs Budget Management Stakeholder Management Risk Management Strategic Planning Data Analysis

Clinical Manager

Creative Pharma & HR Services

Apr 2018 - Present (7 years 3 months)

Managed a team of in-house and outsourced associates, overseeing clinical project start-up activities and ensuring regulatory compliance. Supported cross-functional business development activities, contributing to departmental and overall business annual targets.

Regulatory Compliance Team Management Mentoring Business Development Client Relationship Management Risk Mitigation Change Management Quality Assurance

Regulatory Affairs Manager

AstraZeneca

May 2015 - Present (10 years 2 months)

Supported the development program of FASENRA (Benralizumab) primarily in the EU within a global regulatory program management role. Prepared and delivered regulatory, operational, and risk mitigation plans for MAA application preparations.

Regulatory Affairs Program Management Drug Development Risk Mitigation MAA Cross Functional Collaboration

Regulatory Consultant

GlaxoSmithKline

Jan 2014 - Present (11 years 6 months)

Led global regulatory projects for Clinical Trial Applications, planning workload for initial CTA submissions, deficiency responses, and amendments. Ensured regulatory compliance across a range of markets and led the update of the regulatory compliance database for FASENRA.

Regulatory Project Leadership Clinical Trial Applications (CTA)Regulatory Compliance Quality Assurance Project Timelines Database Management Departmental Objectives Quality Improvement

Sr Regulatory Associate

PAREXEL International

Aug 2012 - Present (12 years 11 months)

Served as Global Regulatory Project Lead on clinical research projects, managing regulatory strategy plans and executing them on time, quality, and cost. Provided input into financial forecasting and managed budget allocation for participating countries.

Regulatory Project Leadership Clinical Research Regulatory Strategy Budget Management Financial Forecasting Client Facing Matrix Environment Quality Control Cost Management

Clinical Trial Specialist II

PAREXEL International

Oct 2010 - Present (14 years 9 months)

Responsible for study start-up activities of Phase I-IV clinical trials, medical device, and non-interventional studies. Led a team of 5 as the UK Study Start-Up (SSU) coordinator for Pfizer Strategic Partnership, ensuring timely completion of activities.

Clinical Trials Study Start Up Team Leadership Performance Management Medical Devices Client Expectations Pfizer Partnership Project Coordination

Clinical Research Officer

UCLH NHS Trust

Jun 2008 - Present (17 years 1 month)

Developed the Multiple Myeloma clinical trials portfolio and project managed the start-up of an Investigator-initiated phase II clinical trial. Contributed to the advancement of clinical research in oncology.

Clinical Research Project Management Oncology Multiple Myeloma Study Start Up Medical Research Healthcare

Clinical Trials Coordinator

NWLH NHS Trust

Jun 2007 - Present (18 years 1 month)

Planned the care and support of patients according to trial protocols in oncology and hematology. Autonomously managed a caseload of patients within a multidisciplinary team.

Patient Care Clinical Trials Oncology Hematology Caseload Management Patient Support Healthcare Clinical Coordination

Scientific Officer

Cancer Research UK

Oct 2002 - Present (22 years 9 months)

Planned and conducted laboratory-based research projects, managing databases relevant to laboratory research. Conducted Bioinformatics data analysis and prepared data for presentations and publications.

Bioinformatics Data Analysis Database Management Scientific Writing Presentation Publications Research

Education

Degrees, certifications, and relevant coursework

Imperial College London

MSc, Human Molecular Genetics

Activities and societies: Indicative Course: Statistical Programming

Completed a Master of Science in Human Molecular Genetics at Imperial College London. Focused on advanced topics in genetics, including statistical programming.

Wolverhampton University

BSc, Genetics & Molecular Biology

Obtained a Bachelor of Science in Genetics & Molecular Biology from Wolverhampton University. This program provided a foundational understanding of genetic principles and molecular biological techniques.

University of Wales, Cardiff

BSc, Genetics

Activities and societies: (Completed @Wolverhampton Univ)

Undertook a Bachelor of Science in Genetics at the University of Wales, Cardiff, with the degree completed at Wolverhampton University. This coursework laid the groundwork for further studies in genetics.