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Project Director II Resume Example

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PROJECT DIRECTOR II
Experience
Project Director II, 01/2017 to 01/2018
University Of Massachusetts Medical School – Shrewsbury , MA
  • Spearheaded project planning, implementation, and resource allocation supporting three full-service studies with orphan status in rare liver diseases, Primary Biliary Cholangitis and Primary Biliary Atresia
  • Directly supervised Project Managers and Clinical Operations Lead to enhance team performance
  • Assigned time-sensitive project activities and routinely provided mentorship and evaluation driving productivity improvements
  • Maintained strict oversight and accountability for clinical study; expertly tracked resources and expenditures alongside budget accountability totaling $53 million
  • Facilitated seamless transition of study responsibilities and documentation for up to 15 vendors for two ongoing global studies (163 sites/31 countries, 50 sites/9 EU countries) with each two years behind in enrollment, as well as a 50-site global study in start-up
  • Led weekly production and operations contractor meetings, facilitating stronger communication and helping to resolve critical issues
  • Monitored, coached and supervised team of three employees in 2018
Project Director, 01/2015 to 01/2017
Ergomed – Waltham , MA
  • Served as U.S. Project lead and functional manager monitoring project goals, timelines, and deliverables for two projects on Nonalcoholic Steatohepatitis / Nonalcoholic Fatty Liver Disease (NASH/NAFLD) pharmaceutical product development
  • Supervised Sr/Project Managers, five of which were leading oncology studies
  • Was directly involved in pharmacy manual development, timeline development, budget negotiations, weekly safety meeting attendance/documentation for two of the five referenced oncology studies
  • I was responsible for ensuring quality project implementation according to clearly delineated contract expectations and requirements as well as serving as a Sponsor interface along with the Project Manager
  • Partnered with investigators and clinical staff to ensure proper training and comprehension of clinical trial processes and protocols
  • Credited for project data quality and compliance by routinely monitoring Project Manager activities and providing effective coaching
  • Collaborated with cross-functional teams including the Ethics Committee and regulatory staff to devise innovative solutions for clinical study and pharmaceutical trial-related issues
  • Successfully co-developed site responses for third party and FDA audit findings
Project Director, 01/2010 to 01/2015
Ergomed – Cary , NC
  • Orchestrated implementation of clinical projects in indications of Chronic Insidious Constipation, Pediatric Chronic Pain, and Amyotrophic Lateral Sclerosis and the rare disease, Pompe Disease
  • Established reputation for resourcefulness
  • Inspired and trained cross-functional teams enabling completion of time-sensitive, compliant deliverables
  • Commended for skillful management of budgeting, targeted timeline improvements, and allocation of resources for clinical projects
Senior Director/Director/Program Director/Assistant Director, 01/1999 to 01/2010
Dell – Somerdale , OH
  • Promoted through roles of increased scope and accountability for exemplary performance including Senior Director leadership for four consecutive years
  • Directed global studies focused on various clinical indications, including a cardiovascular mega-trial as well as central nervous system (CNS) psychiatric diseases and Parkinson's Disease studies in the U.S
  • And Europe; schizophrenia research in the U.S., Europe, and Latin America; depression in the U.S
  • And a chronic spinal cord injury project in the U.S., Western Europe, India, Australia, and New Zealand
Senior Director, 01/2008 to 01/2010
  • Adeptly delegated priorities for project management team with as many as 15 direct reports (Assoc
  • PM to Sr
  • Director), supporting professional development regularly and consistently encouraging open communication and mentoring which resulted in team-engagement survey scores as high as those across all therapeutic areas in Project Management
  • Constructed and delivered global workshop on employee engagement and participation benefits for more than 120 CNS study staff across Europe and the U.S
  • Screened prospective CNS Project Management candidates for U.S
  • Region partnering with internal recruiter to vet and select qualified talent for the interview process
  • Executed business plans and developed [Type] tools to facilitate project initiatives, trainings and administrative activities
Senior Program Director/Program Director/Director, 01/2003 to 01/2008
NA – City , STATE
  • Executed operational leadership support and guidance for global, multi-center schizophrenia, osteoporosis and antibiotic clinical projects, a chronic spinal cord injury study, a mega-trial for ST-elevated MI which enrolled 20,400 patients globally across approximately 650 sites in 48 countries across North America, Europe and Asia and a US-based study in Parkinson's Disease
  • Interviewed and hired talented [Job title]s with expertise in [Area of expertise] to increase [Type] strengths within already gifted department
Director/Assistant Director/Director, 01/1999 to 01/2003
Quintiles, Inc – City , STATE
  • Facilitated operations for research sites, including selecting and maintaining sites, and served as primary point-of-contact for contract research organizations and other third party vendors
  • Contributed valuable solutions as participant in several task force initiatives, such as providing subject area-expertise for the Clinical Management Plan template SOP review and updates and a manual for successful collaboration with CROs
  • Co-authored Clinical Study Reports and safety sections of special interest of two NDAs
  • Both compounds were approved by FDA
Manager/Assistant Director/Senior Clinical Research Associate, 05/1985 to 12/1999
Quintiles, Inc. – City , STATE

Additional experience as Manager/Assistant Director/Senior Clinical Research Associate, Clinical Operations, HOECHST MARION ROUSSEL, Kansas City, Missouri, and Outpatient Staff Pharmacist,
UNIVERSITY OF KANSAS MEDICAL CENTER, Kansas City, Kansas.

Work History
Project Director II, 01/2017 to 01/2018
HOECHST MARION ROUSSEL, UNIVERSITY OF KANSAS MEDICAL CENTER – City , STATE
  • Spearheaded project planning, implementation, and resource allocation supporting three full-service studies with orphan status in the rare liver diseases, Primary Biliary Cholangitis and Primary Biliary Atresia.
  • Directly supervised Project Managers and Clinical Operations Lead to enhance team performance.
  • Assigned time-sensitive project activities and routinely provided mentorship and evaluation driving productivity improvements.
  • Maintained strict oversight and accountability for clinical study; expertly tracked resources and expenditures alongside budget accountability totaling $53 million.
  • Facilitated seamless transition of study responsibilities and documentation for up to 15 vendors for two ongoing global studies (163 sites/31 countries, 50 sites/9 EU countries) with each two years behind in enrollment, as well as a 50-site global study in start-up.
Project Director, 01/2015 to 01/2017
Company Name – City, State
  • Served as U.S.
  • Project lead and functional manager monitoring project goals, timelines, and deliverables for two projects on Nonalcoholic Steatohepatitis / Nonalcoholic Fatty Liver Disease (NASH/NAFLD) pharmaceutical product development.
  • Supervised Sr/Project Managers, five of which were leading oncology studies.
  • Was directly involved in pharmacy manual development, timeline development, budget negotiations, weekly safety meeting attendance/documentation for two of the five referenced oncology studies.
  • I was responsible for ensuring quality project implementation according to clearly delineated contract expectations and requirements as well as serving as a Sponsor interface along with the Project Manager.
  • Partnered with investigators and clinical staff to ensure proper training and comprehension of clinical trial processes and protocols.
  • Credited for project data quality and compliance by routinely monitoring Project Manager activities and providing effective coaching.
  • Collaborated with cross-functional teams including the Ethics Committee and regulatory staff to devise innovative solutions for clinical study and pharmaceutical trial-related issues.
  • Successfully co-developed site responses for third party and FDA audit findings.
Project Director, 01/2010 to 01/2015
Company Name – City, State
  • Orchestrated implementation of clinical projects in indications of Chronic Insidious Constipation, Pediatric Chronic Pain, and Amyotrophic Lateral Sclerosis and the rare disease, Pompe Disease.
  • Established reputation for resourcefulness.
  • Inspired and trained cross-functional teams enabling completion of time-sensitive, compliant deliverables.
  • Commended for skillful management of budgeting, targeted timeline improvements, and allocation of resources for clinical projects.
Senior Director/Director/Program Director/Assistant Director, 01/1999 to 01/2010
Company Name – City, State
  • Promoted through roles of increased scope and accountability for exemplary performance including Senior Director leadership for four consecutive years.
  • Directed global studies focused on various clinical indications, including a cardiovascular mega-trial as well as central nervous system (CNS) psychiatric diseases and Parkinson's Disease studies in the U.S.
  • And Europe; schizophrenia research in the U.S., Europe, and Latin America; depression in the U.S.
  • And a chronic spinal cord injury project in the U.S., Western Europe, India, Australia, and New Zealand.
Senior Director, 01/2008 to 01/2010
  • Adeptly delegated priorities for project management team with as many as 15 direct reports (Assoc.
  • PM to Sr.
  • Director), supporting professional development regularly and consistently encouraging open communication and mentoring which resulted in team-engagement survey scores as high as those across all therapeutic areas in Project Management.
  • Constructed and delivered global workshop on employee engagement and participation benefits for more than 120 CNS study staff across Europe and the U.S.
  • Screened prospective CNS Project Management candidates for U.S.
  • Region partnering with internal recruiter to vet and select qualified talent for the interview process.
Senior Program Director/Program Director/Director, 01/2003 to 01/2008
  • Executed operational leadership support and guidance for global, multi-center schizophrenia, osteoporosis and antibiotic clinical projects, a chronic spinal cord injury study, a mega-trial for ST-elevated MI which enrolled 20,400 patients globally across approximately 650 sites in 48 countries across North America, Europe and Asia and a US-based study in Parkinson's Disease.
Director/Assistant Director/Director, 01/1999 to 01/2003
  • Facilitated operations for research sites, including selecting and maintaining sites, and served as primary point-of-contact for contract research organizations and other third party vendors.
  • Contributed valuable solutions as participant in several task force initiatives, such as providing subject area-expertise for the Clinical Management Plan template SOP review and updates and a manual for successful collaboration with CROs.
  • Co-authored Clinical Study Reports and safety sections of special interest of two NDAs.
  • Both compounds were approved by FDA.
Manager/Assistant Director/Senior Clinical Research Associate, Company Name – City, State
Education
PharmD: Pharmacy, 2002
University of Missouri - City
Bachelor of Science: Pharmacy, 1985
University of Kansas - City
Associate of Arts: Pre-Pharmacy, 1982
Allen County Community College - City
Summary

Director of Project Management/Clinical Operations Profile Highly-skilled Project Management/Clinical Operations leader with demonstrated success conducting Phase IIa - IIIb clinical research and directing clinical projects for drug development advancement within pharmaceutical and CRO companies. Thrive in fast-paced, highly-regulated environments requiring meticulous attention to detail. Excel in project management and motivating cross-functional teams supporting global clinical studies. Adept at leveraging extensive education and experience in pharmacology to propel comprehensive research initiatives dedicated to quality patient care.

Publications
Julio Rosenstock, MD, Sherwyn L. Schwartz, MD, Charles M. Clark, MD, Glen Park, PharmD, David W. Donley, PhD, Mike B. Edwards, RPh 28-week comparison of insulin glargine (HOE 901) and NPH Insulin. DIABETES CARE: April 2001, pages 631-636. Rosenstock, J., Schwartz, S., Edwards, M., Donley, D. Efficacy and Safety of HOE 901 (Insulin Glargine) in Subjects with Type 2 DM: A 20-Week Randomized, NPH insulin-controlled Trial. DIABETES: A Journal of the American Diabetes Association, Volume 48, Supplement 1, May 1999, page A100, Abstract 432. Continued. Continued.
Highlights
  • Data Management
  • Pharmacovigilance
  • Staff Development
  • Biostatistics
  • Medical Writing
  • Project Management
  • Ongoing data trend analysis
  • Operational Effectiveness
  • Draft protocol review
  • FDA and EU Regulatory Requirements
  • Vendor Selection, Contracts, and Management
  • Financial Accountability
  • Safety Monitoring
  • Timeline Management
  • Full- service team leadership
  • Benefits, Quality
  • Biostatistics, Recruiter
  • Budgeting, Research
  • Budget, Safety
  • Clinical study, SOP
  • Coaching, Staff Development
  • Contracts, Trend
  • Data Management
  • Documentation
  • Driving
  • Financial
  • Functional
  • Latin
  • Leadership
  • Team leadership
  • Director
  • Mentoring
  • Negotiations
  • Oncology
  • Processes
  • Product development
  • Project lead
  • Project Management
  • Project planning
  • Project restructuring
  • Board of directors support
  • Conceptualizing development projects
  • [Type] directories
  • IIS server configuration
  • Software projects
  • Vocal projection
  • Project specifications
  • Project foreman
  • Test Director 8.0
  • IIBA methodologies
  • Infrastructure projects
  • Project management specialist
  • Project quoting
  • Community project development
  • Project requirements
  • Basel III
  • Project Outreach Plans
  • Transportation Project Planning
  • Project Proposal Creation
  • Project Tracking Database Technology
  • Residential and commercial projects
  • Project creation
  • Capital building projects
  • Bridge and highway projects
  • Search directories
  • Project estimation
  • Multimedia project development
  • Injury and Illness Prevention Program (IIPP)
  • Market projections
  • Special projects
  • Commercial project expertise
  • Growth projections
  • NCAA Division III, NEAC and CSE Rules knowledge
  • Active Directory
  • E20-II HAP software platform
  • Licensed Funeral Director in [State Name]
  • Planned and directed full testing lifecycle for [Type] projects
  • New project development
  • Fiscal balances projection
  • Flooring project management
  • Project assistance
  • Project Variance Audits
  • Project Setup Sheets
  • Forensic Project Analysis
  • Project Roadmap Design
  • Project-Level Hardware Planning
Skills
  • Data Management
  • Pharmacovigilance
  • Staff Development
  • Biostatistics
  • Medical Writing
  • Project Management
  • Ongoing data trend analysis
  • Operational Effectiveness
  • Draft protocol review
  • FDA and EU Regulatory Requirements
  • Vendor Selection, Contracts, and Management
  • Financial Accountability
  • Safety Monitoring
  • Timeline Management
  • Full- service team leadership,
  • Benefits, Biostatistics, budgeting, budget, clinical study, coaching, Contracts, Data Management, documentation, driving, Financial, functional, Latin, Leadership, team leadership, Director, mentoring, negotiations, oncology, processes, product development, project lead, Project Management, project planning, protocols, quality, recruiter, research, Safety, SOP, Staff Development, trend
  • Additional Information
    • Registered Pharmacist (RPh), State of Kansas Pharmacist License 1-10857
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    Resume Overview

    School Attended

    • University of Missouri
    • University of Kansas
    • Allen County Community College

    Job Titles Held:

    • Project Director II
    • Project Director
    • Senior Director/Director/Program Director/Assistant Director
    • Senior Director
    • Senior Program Director/Program Director/Director
    • Director/Assistant Director/Director
    • Manager/Assistant Director/Senior Clinical Research Associate

    Degrees

    • PharmD : Pharmacy , 2002
      Bachelor of Science : Pharmacy , 1985
      Associate of Arts : Pre-Pharmacy , 1982

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