Melissa J.

Melissa J.

Clinical Operations Consultant

About

*PMP-Certified pharmaceutical industry profession with over 20 years of experience which includes over 10 years of Clinical Project Management experience and over 5 years of Clinical Monitoring experience *Participated in and provided direction and leadership throughout Phase I-IV of clinical research in many therapeutic areas *Experienced Clinical Project Management experience within small niche Sponsor/CRO companies as well as large Sponsor/CRO companies *A successful leader able to drive a cross-functional clinical team ensuring robust project and risk management planning as well as delivering studies on time and within budget *Consistently relied upon to prepare quality deliverables to adapt quickly to shifting priorities, and to provide insight and suggest solutions to strategic challenges *Experienced with both functional and line management Therapeutic Experience: *Oncology *Rare Disease *Vaccines *CNS * Autoimmune * Endocrinology *Respiratory *Infectious Disease

Country

United States

City

Washington DC-Baltimore Area

Industry

Pharmaceuticals

Skill

Institutional Review Board (IRB), Vendor Management, Clinical Protocols, Research Skills, Presentations, Written Communication, Program Implementation, Teamwork, Multi-national Experience, Critical Thinking, Outsourcing, Timelines, Regulatory Guidelines, Microsoft Excel, Problem Solving, Site Selections, Skill Development, Microsoft Office, Supplier Evaluation, Data Integrity

Experience

Apis Cerana Clinical, LLC

Clinical Operations Consultant

Apis Cerana Clinical, LLC

2023-8 - Present · 3 yrs 2 mos

Washington DC-Baltimore Area

uniQure

Senior Clinical Trial Manager

uniQure

LinkedIn
2024-6 - 2025-3 · 10 mos

Operational oversight for Phase 1b/II Huntington’s Disease Gene therapy study

Immunomic Therapeutics, Inc.

Senior Clinical Project Manager

Immunomic Therapeutics, Inc.

LinkedIn
2022-9 - 2023-8 · 1 yr

United States

Daiichi Sankyo US

Senior Clinical Trial Manager

Daiichi Sankyo US

LinkedIn
2020-8 - 2022-7 · 2 yrs

United States

Sarah Cannon Cancer Network

Senior Clinical Project Manager

Sarah Cannon Cancer Network

LinkedIn
2019-8 - 2020-8 · 1 yr 1 mo

United States

Merck

Senior Study Manager

Merck

LinkedIn
2016-8 - 2019-5 · 2 yrs 10 mos

Washington D.C. Metro Area

Sigma-tau

Senior Clinical Research Manager

Sigma-tau

LinkedIn
2014-9 - 2016-8 · 2 yrs

Washington D.C. Metro Area

Astellas Pharma

Clincal Study Manager

Astellas Pharma

2012-6 - 2014-7 · 2 yrs 2 mos

Greater Chicago Area

MedImmune

Project Manager

MedImmune

LinkedIn
2009-9 - 2012-5 · 2 yrs 9 mos

Washington D.C. Metro Area

Premier Research

Project Manager

Premier Research

LinkedIn
2008-7 - 2009-9 · 1 yr 3 mos

Raleigh-Durham, North Carolina Area

Education

Medical University of South Carolina

Medical University of South Carolina

LinkedIn

Health/Health Care Administration/Management

College of Charleston

College of Charleston

LinkedIn

History

Melissa J.'s Contact Information

Email

******@***.com

Phone

(**) *** ****

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