Registered Nurse Manager

Debbie Ruffo

*** ***** ****

Phoenixville, PA ***60

Phone:610-***-****

Email: ***********@*******.***

WORK EXPERIENCE:

Assistant Director I, Global Trial Leader - Neuroscience

Pfizer (formerly Wyeth Research), Collegeville, PA

August 2008 - Present

Responsibilities:

. Plan, manage, and execute the Adult Major Depressive Disorder (MDD)

Program which consists of three large global Phase III studies

(2200 subjects at 220 sites in 18 countries) and a Phase II

Pediatric dose finding MDD study in the US. Enrollment for all

three adult studies has or will close months of ahead of original

projections.

. Ensure regulatory compliance and GCP adherence at the study level

. Create and drive study level timelines

. Take corrective action(s) for major study level issues

. Coordinate, facilitate and conduct training at Investigator

Meetings, Regional Study Manager (RSM) and Site Manager (SM)

meetings

. Develop operational tools for RSMs, SMs and sites.

. Ensure standard processes, tools and procedures used consistently

and globally.

. Coordinate with functional areas and regions for input on study

management - study start up through database freeze

. Write/coordinate review of monitoring plan for entire study, across

all regions.

. Interact with Regulatory organizations at the study level.

. Drive the CTA/IMPD to submission readiness as well as ensuring that

each region has their country specific requirements available for

an accelerated or on-time study start up (ie, required

translations, CMC)

. Drive the development of the study database and coordinate with

Data Management to assure data capture and cleaning is acceptable

with study timelines across regions.

. Provide study progress reports to senior management

. Provide input on the financial forecasts and responsible for the

overall management of the study budget

. Responsible for the selection and management of central vendors

(e.g., labs, raters, etc)

. Facilitate monitoring activities from pre-study to study close-out.

. Participated in a global initiative to identify efficiencies in the

country start-up process in order to reduce the metric from final

protocol to study start-up in all regions

Global Trial Leader (Infectious Disease and Cardiovascular)

Wyeth Research (Collegeville, PA)

December 2007- August 2008

Responsibilities:

. Plan, manage and execute large, global, Phase III studies in

several therapeutic areas in both adult and pediatric populations.

Infectious Disease: Phase 3, sNDA program - Hospital-Acquired

Pneumonia (HAP) approximately 1000 subjects at 308 sites in 43

countries; Community-Acquired Pneumonia (CAP) 400 subjects at 85

sites in US/CA/LA; Diabetes Foot Infection (DFI) which included

approximately 954 subjects at 226 sites in 38 countries ; also

small Phase 2 Pediatric dose finding study, and Hepatitis C Virus

(HCV).

. Coordinate with functional areas and regions for input on study

management - study start up through database freeze

. Ensure standard processes, tools and procedures used consistently

and globally.

. Write/coordinate review of monitoring plan for entire study, across

all regions.

. Interact with Regulatory organizations at the study level.

. Coordinate with Data Management to assure data capture and cleaning

is acceptable with study timelines across regions

. Facilitate monitoring activities from pre-study to study close-out.

Senior Clinical Trial Manager (Infectious Disease and Cardiovascular)

Wyeth Research (Collegeville, PA)

2003-2007

Responsibilities:

. Responsible for leading the study team in the planning and

execution of large, Phase III sNDA Infectious Disease trials in

HAP/CAP and DFI

. Developed and maintained the study execution plan.

. Managed global site selection/start-up process through to study

close out.

. Maintained the study budget and reviewed all study payment and

reconciled with the budget.

. Site management/trip report review

. Track enrollment

. Manage and oversee central labs and CRO's.

. Coordinated data management activities

. On-going recruitment activities for a difficult indication to

enroll

. Road Show to Latin America to present preliminary results of the

CAP studies

Senior Clinical Scientist I

Wyeth Research (Collegeville, PA)

1999 - 2003

Responsibilities:

. Study team leader and protocol author for a Phase II infectious

disease (HCV) study and multiple Phase II cardiac studies

. Participate in the planning, development, implementation and

monitoring of clinical trials.

. Preparation of clinical documents (protocols, protocol amendments,

ICF, study summaries) and other documents, as required.

. Assist in preparation of IND reports and other regulatory

submissions

. Assist with the development of case report forms and data

validations.

. Review clinical trial data, resolve non-medical data queries and

issues, assist medical monitor in resolving medically-related

queries and issues as well as SAE reporting and reconciliation.

. Assist in evaluation for interim and final results of study data

. Evaluate potential study site suitability and conduct study site

initiation and monitoring visits.

. Plan, organize, and present at investigator meetings.

. Track patient enrollment and data entry flow

. Assist in obtaining budgetary information and coordinating payments

. Coordinate activities of ancillary support groups including

statisticians, data management, project writers CROs and assist in

interdepartmental problem solving.

Senior Drug Information Coordinator

Wyeth-Ayerst (Saint Davids, PA)

1998 - 1999

Responsibilities:

. Answer the medical information telephone line. Obtain, through

appropriate questioning and interpretation, pertinent information

with regard to caller inquiry; enter that information into computer

database.

. Obtain adverse drug experience information from consumers and

health care professionals when appropriate.

. Utilize basic medical knowledge; provide answers to medical

information questions.

. Assist Product Information managers in answering medical queries

via assimilation of appropriate information to be used in responses

and by writing initial drafts of responses.

Staff Nurse

Reading Hospital and Medical Center (Reading, PA)

1995 - 1998

Responsibilities:

. Medical and Surgical Telemetry floors & PTCA/Interventional

Recovery Room.

. Participated as a team member in the care of hardwire, telemetry,

cardiac and medical-surgical patients, while providing extensive

pre and post operative teaching for patients who had open heart

surgery.

. Collaborated with physicians and other health care professionals to

optimize patient care.

. Served as Charge/Triage nurse on a rotating basis with

responsibility for organizing and assigning unit workload, as well

as supervising patient care activities.

Charge Nurse

Dowden Nursing and Rehabilitation (Newtown Square, PA)

1995 - 1995

Responsibilities:

. Responsible for administration of all residents' medications, as

well as ordered treatment.

. Sub-Acute Unit - provided skilled nursing care, including care of

ventilator dependent patients.

. Responsible for supervision of LPNs and Nursing Assistants.

EDUCATION:

Currently enrolled in the Masters of Science in Clinical Research

Organization and Management

Drexel University (Philadelphia, PA)

Bachelors of Science in Nursing, 1999

Immaculata University (Immaculata, PA)

Associates Degree in Registered Nursing, 1995

Brandywine Hospital School of Nursing, (Coatesville, PA)

LICENSES/ACCREDITATIONS:

Registered Nurse - Pennsylvania

COMPUTER SKILLS:

Proficient in Microsoft Word, Power Point, Excel, MS Project Timeline,

EDMS, RDC, RAVE

Signature: ___________________________ Date: ______________________

Contact this candidate