oelle 

Hirthe
84506 Hane Forest 
Phoenix 
AZ 
 
Phone
 +1 (555) 678 5489
EXPERIENCE
Detroit, MI
CLINICAL RESEARCH PROJECT MANAGER
04/2014 – present

 Works with third party vendors to set up the eLearning workspace for raters
according to project specifications
 Working very closely with a small clinical team, apprising senior clinical
management on a daily basis regarding trial status
 Provides complex scientific & technical leadership in determining research
priorities & the plan, design & execution of research projects ensuring that programs
of investigation meet specified objectives
 Strong working knowledge of Good Clinical Practices (GCP), U.S. Food and Drug
Administration (FDA) regulations, and International Committee on Harmonisation
(ICH) guidelines
 The Clinical Research Project Manager (CRPM) is responsible for the overall
coordination and management of clinical projects/studies from start up through
close out activities
 Works with major functional area leads to identify and evaluate fundamental
issues on the project, make good business decisions and ensure solutions are
implemented
 Provides complex scientific and technical leadership in determining research
priorities and the plan, design and execution of research projects ensuring that
programs of investigation meet specified objectives

Dallas, TX
MARKET RESEARCH PROJECT MANAGER
05/2010 – 02/2014

 Setting up new projects, in close coordination with client facing and operations
teams
 Managing multiple projects independently
 Monitoring projects while in field to ensure quality and timely completion
 Coordinating and managing internal data collection activities to client
specifications, on time and on budget
 Preparing analysis and drafting story-driven client facing reports for senior
review
 Interacting with clients and developing relationships with them as a go-to person
on the Kantar Added Value team
 Collaborates in cross-functional project team

Boston, MA
RESEARCH PROJECT MANAGER
11/2004 – 03/2010

 Providing direct input into strategic planning, development management

processes, and project management from conception through development cycle
 Work closely with Regulatory specialists to manage open protocols, perform
continuing reviews and accrual updates
 Develop infrastructure, procedures, and tracking systems for project
management services performed
 Develops costing and provides input into proposals
 Provide guidance to data analysts on analytical plan and conduct data
management for the study, in collaboration with biostatistics and/or a study data
analyst
 Contributes to product development process optimization by sharing best
practice development, lessons learned, resource leveling and process input
 Leads/manages medium to large size projects, leveraging basic project
management tools to deliver results

EDUCATION
Bachelor’s Degree in Public Health
EAST CAROLINA UNIVERSITY
SKILLS

 Five or more years of experience in a healthcare research setting including

experience in budget development, grants management, space management and/or
personnel management.At least three years experience in a scientific laboratory
 Knowledge and experience with longitudinal modeling methods, latent variable
analysis of health care outcomes, transitions and trajectories would be particularly
advantageous as would knowledge and experience with health care policy, health
services research, health outcomes studies, pharmacoeconomics, and
pharmacoepidemiology
 Identifies best practices in investigator-initiated clinical trials and other clinical
research on children with developmental disabilities through discussions with
funding agencies, regulatory officials, and professionals from multi-site study
collaborations
 Strong experience in complex statistical programming of large longitudinal
datasets utilizing SAS and other statistical analysis software. Experience in the
analysis of both qualitative and quantitative data
 Able to demonstrate professional knowledge within a university science
discipline to give advice and guidance to internal and external customers
 Seven Years’ experience of practical data analysis experience and experience
working with end-users to develop reports, dashboard indicators, and key
performance measures using various analytical tools and systems
 Good organizational skills with strong interpersonal, time management, and
analytic skills; the ability to conduct analyses efficiently and expeditiously while
maintaining a high level of accuracy and attention to detail; and the ability to
communicate effectively the results of work to colleagues
 Ability to communicate conceptually detailed and complex information
effectively and professionally with a wide range of people
 Strong attention to details, process oriented, and organized. Lateral thinker and
problem solver
 SAS Macro and SQL experience and experience in analysis of health care claims
data for health services research are highly desirable
 Cordelia 
Kohler
61527 Mayer Vista 
Chicago 
IL 
 
Phone
 +1 (555) 855 0161
EXPERIENCE
Boston, MA
SENIOR RESEARCH PROGRAM COORDINATOR
09/2014 – present

 Manage projects and work with the PI to convene working group to examine
pediatric palliative care issues (will include handling day to day issues)
 Works with the study team on approved concepts to help write the clinical
research protocol and informed consent document using the TBCRC standardized
templates. Assists the study team with the protocol review process, mainly creation
of slide presentations and preparation of a formal response to any issues raised
during the protocol review meeting. May also assist in the creation of study-related
research documents (eg, project SOPs, procedure manuals, CRFs, etc.)
 7) Analyze data, perform literature searches, abstract data from literature
searches and index gathered data, and contribute to the draft/sections of scientific
manuscripts
 8) Conduct in-person interviews and record reviews with families as part of the
evaluation of home visiting program services
 10) Knowledge of local culture and health, family, support, and education
services and organizations
 13) Participate in monthly and quarterly meetings with various project study
partners and stakeholders
 14) Build rapport with all home visiting program models and maintain effective
working relationships

Los Angeles, CA
RESEARCH PROGRAM COORDINATOR GASTROENTEROLOGY
DAYS MSH
05/2007 – 04/2014
 Provides assistance to the Principle Investigator or Research Manager on grant
applications
 Provides assistance and consultation on basic research or clinical trials
methodologies and statistical analysis issues
 Develops policies and procedures within area of responsibility. Writes and
amends protocols as necessary
 Develops consent forms, screens and enrolls patients, follows patients through
course of study, collects and analyze data. (Clinical Research Only)
 Performs other related duties
 Supervises subordinate personnel and offers guidance on research methods and
techniques
 Assists in the development of budgets for research projects. Completes grant
applications and proposals by developing pilot studies and generating pre-clinical
data

Houston, TX
RESEARCH PROGRAM COORDINATOR
08/2001 – 11/2006

 Collaborate with the principal investigator (PI) and study team on all aspects of
research program development and management
 May assist the Program Manager with conducting affiliate audits
 Works closely with the Research Nurses and Research Assistant to accomplish
the team goals and objectives
 Maintain records of project time and assist with effort allocations
 Assist with testing of research participants
 Develop, design, and implement research projects
 Develop research stimuli for data collection

EDUCATION
Bachelor’s Degree in Related Discipline
UNIVERSITY OF VIRGINIA
SKILLS

 Knowledge of basic project management tools and techniques

 Ability to manage multiple projects at once to ensure all details are being covered
 Excellent written and verbal communication skills as well as impeccable
organizational skills
 Effective communicator with excellent written, verbal, and interpersonal skills
 Ability to work independently as well as part of two research teams. Interpersonal
skills to interact with research participants
 Knowledge of MS Office suite (Word, Excel), email software (MS Exchange or
similar), Adobe, internet browser, web content management system (WordPress or
similar), electronic IRB software
 10% Utilizing working knowledge will assist in study design, will contribute in the
development of standard operating procedures, and will recommend changes to
operational procedures based on results and goals of a study(s)
 10% Using data collection instruments and protocols developed in collaboration
with study investigators, supervise all data collection with study participants at
multiple study sites
 10% Utilizing working knowledge of study(s) will participate in meetings to
provide operational updates, report on any operational issues, and make
recommendations for resolutions to new/outstanding operational issues
 Manage the purchasing process for the UX Research team – work with external
vendors, process SOWs, POs, and resolve issues and answer questions about the
purchasing process

RANDALL LITTLE
26711 Vandervort Inlet,  Boston, MA
+1 (555) 533 4125

WORK EXPERIENCE

CLINICAL PROJECT MANAGER

03/2016 - PRESENT
Dallas, TX

 Responding to inquiries in a professional, courteous and timely manner

 Reading, understanding and adhering to organizational Standard Operating
Procedures (“SOP”)
 Establishing and enforcing departmental standards
 Reviewing and updating company SOPs related
 Collaborates with Vendor Management, clinical team and regional groups to identify
vendors and provides oversight of CRO performing the clinical operations functions
for the clinical trials within the program
 Ensures that the study logistics related to vendors (IVRS/ Central Lab etc) in
protocol, are consistent with other study documents
 Communicates the timeline and deliverables to the vendors
  Establishes the budgets for each of the studies within the clinical program with
assistance from finance, the regional group and in collaboration with the operational
center
 Participates and/or Arranges for the Protocol Feasibility within GCO

SENIOR CLINICAL PROJECT MANAGER

01/2010 - 01/2016
Houston, TX

 Participates in the review of the protocol and provides input from an operational
perspective Distributes study protocol to the CRO or all participating countries &
related parties. Collects and communicates reasons for a protocol change to
responsible author on behalf of GCO
 Approves final case report form design
 Reviews and approves Clinical Trial Agreements and other contracts required to
conduct programs that cannot be completed by the vendor
 Provides/Establishes parameters for the final investigator fees and Pass Through
expenses
 Leads the vendor selection team and works closely with Strategic Sourcing personnel
to identify and manage CROs, vendors, and consultants
 Reading, understanding and adhering to organizational Standard Operating
Procedures (SOPs)
 Participating in the modification of company SOPs and/or Process Documents
related to the therapeutic team
 Reviewing and providing recommendations to management on operational
procedures, and by participating in process improvement initiatives
 Communicating job expectations to APM’s

ASSISTANT CLINICAL PROJECT MANAGER

04/2005 - 11/2009
Los Angeles, CA

 Responsible to ensure sites are ‘GCP’ compliant and following local and regulatory
guidelines
 Good project management skills thorough knowledge of Good Clinical Practice,
clinical trial design, statistics, regulatory processes, and global clinical development
process
 Resolve issues with minimal supervision and understand when to escalate.
Willingness to act accountably in project / trial management
 Demonstrated leadership skills and the ability to solve problems proactively
 Equivalent level of education and experience
 Clinical Monitoring or Data Management experience required
 Excellent and demonstrated verbal and written communication and presentation
skills
 Work independently, prioritize and work with in a matrix team environment is
essential
EDUCATION

GRAND VIEW UNIVERSITY

2000 - 2005
Bachelor's Degree in Life Sciences

PROFESSIONAL SKILLS

 Demonstrate excellent multiple tasking skills in a matrixed team environment with

the ability to shift priorities effectively
 Demonstrate excellent critical thinking, time management and organizational skills
to meet multiple deadlines, conflicting priorities and demanding workload
 Proven leadership skills, executive presence, maturity, emotional intelligence, and
written/oral communication skills
 Interpersonal skills, including ability to build strong working relationships and
effectively manage and resolve conflict
 Strong prioritisation, problem solving and time management skills
 Proven complex problem solving and decision making skills
 Demonstrated strengths in planning, organizational, analytical skills, time
management, problem solving, and attention to detail
Project Assistant ROBERT SMITH Phone: (123) 456 78 99 Email: info@qwikresume.com Website:
www.qwikresume.com LinkedIn: linkedin.com/qwikresume Address: 1737 Marshville Road, Alabama.
Objective Highly qualified Project Assistant with experience in the industry. Enjoy creative problem
solving and getting exposure on multiple projects, and I would excel in the collaborative environment on
which your company prides itself. Skills MS Word, Excel, Outlook, Internet Explorer. Maxwell,
QuickBooks, Timberline, Great Plains Accounting Software. Work Experience Project Assistant ABC
Corporation  August 2000 – August 2005  Prepared Schedule of Values for billing purposes.  Created
spreadsheets for special billing forms, releases, etc.  Coordinated, tracked and processed AIA billings
for all projects including support documentation of costs.  Tracked job cost estimates of change orders
and processed for billing.  Processed and distributed submittals to meet contractual deadlines.  Set
up and maintained equipment sheets for each project tracking equipment purchased, lead times,
release dates and delivery dates.  Prepared and maintained RFI forms and logs. Project Assistant ABC
Corporation  1998 – 2000  CEC Construction Management - Lancaster, CA (Outpatient Imaging Center
at Antelope Valley Hospital) Assisted Project Management Company with administrative tasks on large
hospital project.  Transcribed meeting minutes and distributed via Email transmittal.  Reviewed
Payment Application submitted by contractor for accuracy and correct percentage of completion. 
Received and coordinated RFI distribution.  Transmitted submittal documents to Architect for review
and followed up for timely return.  Ordered and distributed Project Plans.  Assisted Project Manager..
Education High School Diploma in Secretarial/Clerical - (Emmaus High School - Emmaus, P