Montgomery Street, San Francisco, CA94105609 Johnson Ave., 49204, Tulsa, OK
H: (555) 432-1000
C:
resumesample@example.com
Date of Birth:
India:
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single:
Experience
Project Director II, 01/2017 - 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
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
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
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 - 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 - 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 - 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 - 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 - 01/2018 SYNEOS HEALTH – Raleigh, NC
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 - 01/2017 PAREXEL INTERNATIONAL – Billerica, 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 - 01/2015 PRA HEALTH SCIENCES – Lenexa, KS
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.
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 - 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 - 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.
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, - HOECHST MARION ROUSSEL, UNIVERSITY OF KANSAS MEDICAL CENTER – Kansas City, Missouri, Kansas
Education
PharmD: Pharmacy, Expected in 2002 - University of Missouri - Kansas City, MO, GPA:
Bachelor of Science: Pharmacy, Expected in 1985 - University of Kansas - Lawrence, KS, GPA:
Associate of Arts: Pre-Pharmacy, Expected in 1982 - Allen County Community College - Iola, KS, GPA:
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. Claire, RPh 28-week comparison of insulin glargine (HOE 901) and NPH Insulin. DIABETES CARE: April 2001, pages 631-636.
Rosenstock, J., Schwartz, S., Claire, 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
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School Attended
University of Missouri
University of Kansas
Allen County Community College
Job Titles Held:
Project Director II
Project Director
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
