Melissa Serrano, MS, PMP

Melissa Serrano, MS, PMP

Senior Project Manager at PPD

Location
Greater New York City Area
Industry
Pharmaceuticals

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Melissa Serrano, MS, PMP's Overview

Current
  • Senior Project Manager at PPD
Past
  • Clinical Research Specialist at Merck
Education
Connections

258 connections

Melissa Serrano, MS, PMP's Summary

PMP certified Global Clinical Trial Manager with over 13 years diverse experience in the areas of clinical science, finance, operations and study management. In-depth knowledge of clinical trials and proven ability to effectively manage multiple studies simultaneously. Effective global team leader that delivers high quality results exceeding timelines and expectations. Recognized for exceptional clinical finance, time and people management capabilities. Experience in Phase I-IV, and therapeutic areas: Diabetes, Endocrinology, Cardiology, and Virology.

Melissa Serrano, MS, PMP's Experience

Senior Project Manager

PPD

Privately Held; 10,001+ employees; PPDI; Pharmaceuticals industry

August 2012Present (2 years 2 months)

Responsible for the overall coordination and management of clinical trials from start-up through close out. Manage direct technical and operational aspects of the project to ensure compliance with FDA regulations and PPD procedures. Work across functional areas to identify and evaluate any issues, interpret data and implement solutions in order to ensure successful completion of trials. Oversee project specific training for project team members. Analyze costs, personnel hours and project needs to determine the most cost effective and efficient means to ensure that all project deliverables meet the client’s needs and adhere to the contract.

Global Studies Manager

Hoffmann-La Roche

Privately Held; 10,001+ employees; Biotechnology industry

August 2008August 2012 (4 years 1 month) Nutley, NJ

Provided operational, financial, and study management expertise and leadership on two Phase IIB/III outsourced cardiovascular imaging studies within Dalcetrapib program and one virology Phase II,18 donor protocol participation, surveillance study within Mericitabine and Danoprevir programs.

Clinical Finance Manager

Merck

Public Company; 10,001+ employees; MRK; Pharmaceuticals industry

20062008 (2 years) Rahway, NJ

Acted as Diabetes and Endocrinology therapeutic area head and manager for 3 direct reports responsible for fifteen Phase III-IV trials. Established clinical financial specialist department at Banyu Pharmaceutical (Merck & Co., Inc. Asia Subsidiary). Trained and mentored new financial specialists.

Clinical Financial Specialist

Merck

Public Company; 10,001+ employees; MRK; Pharmaceuticals industry

20032006 (3 years) Rahway, NJ

Phase I -III lead financial specialist in planning, initiation, maintenance, and closure of clinical trials within Diabetes, Endocrine, Cardiology, Bone and Clinical Pharmacology Departments.

Clinical Research Specialist

Merck

Public Company; 10,001+ employees; MRK; Pharmaceuticals industry

July 2001December 2002 (1 year 6 months)

Phase II and III lead clinical specialist in planning, initiation, maintenance, and closure of trials within Endocrine and Metabolism Clinical Departments. Managed investigator sites participating in clinical trials within PPAR and DPP-IV (Januvia) programs throughout life of each study, ensuring adherence to GCP guidelines, Merck standard operating procedures, and overall protocol compliance.

Melissa Serrano, MS, PMP's Organizations

  • American Diabetes Association

    Member
    • March 2014 to Present
  • Project Management Institute

    Member
    • May 2012 to Present

Melissa Serrano, MS, PMP's Languages

  • Spanish

Melissa Serrano, MS, PMP's Skills & Expertise

  1. Clinical Development
  2. EDC
  3. Therapeutic Areas
  4. GCP
  5. Clinical Monitoring
  6. Clinical Trials
  7. CRO
  8. Clinical Data Management
  9. ICH-GCP
  10. CTMS
  11. Outsourcing
  12. Diabetes
  13. Virology
  14. Endocrinology
  15. Metabolism
  16. Clinical Operations
  17. Direct Line Management
  18. Cardiology
  19. Obesity
  20. PMP
  21. clinical finance
  22. Cross-functional Team Leadership
  23. Drug Development
  24. FDA
  25. Clinical Research
  26. Pharmaceutics
  27. Oncology
  28. Pharmaceutical Industry

View All (28) Skills View Fewer Skills

Melissa Serrano, MS, PMP's Education

University of Medicine and Dentistry of New Jersey

Master of Science, Microbiology and Molecular Genetics

19992001

Franklin & Marshall College

Bachelor of Arts, Biology and Business Administration

19951999

Graduated Pre-Med

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