Project Manager Management
Resume:
LAURA L. HILL, MBA
******@*****.***
Paoli, PA 19301
OBJECTIVE: To obtain a position in which my previous experience will be
enhanced and applied to support initiatives.
EDUCATION: The Pennsylvania State University, Malvern, PA, June, 2011
Master of Business Administration: Biotechnology and Health
Industry Management
The Pennsylvania State University, University Park, PA, May,
2005
Bachelor of Science: Biobehavioral Health; Minor: Health Policy
Administration
THERAPEUTIC AREAS: Biomarkers, Cardiovascular (Myocardial Infarction,
Cardiac Device), Immune System Disorders (Autoimmune Disease, Arthritis),
Imaging (X-Ray, CT, Positron Emission Tomography, MRI, Ultrasound),
Immunotherapies, Neoplasms- Benign, Malignant and Unspecified (Breast
Cancer, Head/Neck Cancer, Lung Cancer/Non-Small & Small Cell Lung Cancer,
Lymphoma, Melanoma, Myeloma).
EXPERIENCE:
ICON Clinical Research, North Wales, PA: June 2011- present
Clinical Data Lead II: August 2012-present
. Supervise and develop team- lead and motivate staff according to
organizational goals
. Lead Data Management point of contact for day to day activity on study
for internal and external partners
. Oversee and coordinate tasks delegated to the study team members both
locally and in other offices
. Identify and prioritize resource needs and daily activities of
clinical trial team
. Plan, implement, and deliver clinical trial projects in accordance
with contracted requirements
. Identification and review of change orders for the budget
. Ensure standard metrics and status reporting are set up and maintained
on study
. Represent DM at Bid Defense meetings as requested and provide input in
support of Business Dev activities
. Develop and deliver internal/external presentations and training.
Attend and present at international investigator meetings
. Lead the development of specifications, implementation, testing of
eCRF or paper CRF edit checks and data review, overview listings.
. Assist with development, review, and modification of applicable
Guidance, WP's, and SOP's
Data Management Project Leader: June 2011- August 2012
. Plan, implement, and deliver clinical trial projects in accordance
with contracted requirements
. Deliver project to quality, timeline, and budget requirements. Manage
resources and costs
. Lead Data Management point of contact for day to day activity on
study, overseeing and coordinating tasks
. Assist with the management of the day-to-day activities of the Data
Management study team.
. Ensure all necessary study specific training is provided to study team
to improve performance and knowledge. Provide coaching / mentoring as
necessary
. Develop and deliver internal/external presentations and training
. Assist with development, review, and modification of applicable
Guidance, WP's, and SOP's
. Coordinate and develop team capability
. Maintain and develop processes and systems
American College of Radiology (ACRIN), Philadelphia, PA: May 2006- June
2011
Data Management Study Lead/Project Manager
. Coordinate data management/project management activities for The
National Lung Screening Trial, including:
o Managing priorities and providing supervisory leadership to NLST
data managers/trial support
o Coordinating medical records collection, coding, and
reimbursement for primary analysis
o Processing of over 100,000 validation errors on over 130 case
report forms for an early database lock
. Interact with patient advocacy groups, investigators, and disease site
teams to promote and encourage accrual
. Present and train principal investigators/providers at ACRIN
Investigator meetings and during study set-up
. Communicate timelines and organize meetings with study protocol teams,
scientific leadership, and statistical department to maintain
timelines for database lock, interim analysis, and reporting
. Run financial management/reimbursement of clinical trials, including
budget planning, resource allocation and preparation of quarterly
reports
. Support ACRIN core laboratories and assists radiologists in producing
quantitative/qualitative endpoints
. Conduct reader training and monitors onsite assessments/reads
. Assist in transition and implementation of department transition to
Medidata Rave electronic data capture
. Serve as key department liaison for training new employees,
statisticians, imaging, and study coordinators
. Verify electronic medical data/coding with regard to compliance and
consistencies for final data analysis
. Function as lead data manager/coordinator/on-site CRA on ACRIN
diagnostic and image-guided therapy studies
. Authors and reviews various departmental SOP's, Work Instructions, and
Data Management Plans
Centocor Research and Development, Inc., Malvern, PA
Johnson and Johnson Co-op: June 2004-Sept 2004, June 2005-Dec 2005
. Responsible for the receipt, processing, and tracking of all clinical
trial samples
. Implemented a new process for sample storage following a move of the
clinical pharmacology department that reduced receipt and processing
time by over 50 percent
. Educated departmental staff on sample tracking and storage by creating
a standard orientation module
. Trained in Good Laboratory Practices (GLPs) and SOP compliance
. Attended quarterly conferences and round tables relating to clinical
pharmacology studies
Family Life Project, University Park, PA: 2004
. Utilized strong team work skills to complete over 5,000 research kits
in under a month's time
. Lead weekly team meetings to discuss current genetic and hormonal
research
. Coordinated dissemination of research kits to participating families
in Center County, PA
. Gained valuable lab experience working with several university-lead
epidemiology studies
. Participated in concept and protocol reviews for up and coming
department studies
CERTIFICATIONS: Certified Clinical Data Manager (CCDM). Competencies
include: data management, project management, medical coding, clinical
database design, query resolution and tracking, adverse event
reconciliation, database lock, knowledge of FDA Code of Federal Regulations
and ICH Good Clinical Practice (GCP).
SKILLS: Excellent verbal and written communication, Presenter at
international client Investigator meetings, Member of the Society for
Clinical Data Management; four-time VISTA award winner for outstanding
teamwork and achievement, great interpersonal skills; strong organization
with great attention to detail; ability to work as a team leader and
individually on multiple client projects, extensive knowledge of medical
terminology, oncology and the clinical trial process; advanced computer
skills: Windows/Microsoft Office(PowerPoint, Excel, Word, Outlook), Adobe,
Application Xtender Document Management System, Clinical Trial Management
Systems, SAS, Medidata, RAVE, Oracle Clinical, SPSS data processor,
Minitab.
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