Michael W. Kreuter, MS

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

Stroudsburg, PA 18360

570-***-****

Cell: 267-***-****

abhjg5@r.postjobfree.com

EDUCATION: Almeda University, MS Healthcare Administration, Graduate -

2007

Almeda University, BS Healthcare Administration, Graduate -

2005

DoD Human Resources Supervisor Certification Course,

annually 1982-1996

U.S. Naval Drug and Alcohol Abuse Counselors Course, Diploma

- 1982

U.S. Naval School of Advance Health Science, Graduate - 1977

U.S. Naval School of Allied Health Sciences, Graduate -1976

PROFESSIONAL EXPERIENCE:

February 2009 Clinical Outsourcing (Contractor)

to Present Clinical Operations sanofi pasteur, Swiftwater, PA

Responsible for North American Clinical Outsourcing. The Clinical

Duties: Outsourcing Contractor serves as a key team member for the

selection, contract implementation and management of CROs and

Clinical Vendors. By helping facilitate the company's outsourcing

strategy, the primary responsibilities of the Clinical Outsourcing

Contractor is to align the appropriate vendor(s) according to

company's purchasing, financial and legal policies.

Daily responsibilities include: oversight of the outsourcing

budget, provide outsourcing financial data (AED, budgetary, etc

ongoing relationship management of the vendors, support platform

members in CRO management and provide vision for the Clinical

Department on outsourcing strategy. Specifically, outsource the

Clinical Data Management and Biostatistics services using my

experiences in strategic planning for Data Management, SAS

Programming and Biostatistics.

Accomplishment Developed a corrective action plan that cleared a very large

s: backlog of invoices for a strategic partner. Cleared numerous

work order and change orders allowing for contract updates keeping

key studies funded and preventing study slow down.

Maintain and negotiated Strategic Partnerships for Clinical

Activities in accordance with company outsourcing strategy.

Partnership values varied by Department and ranged from $1 M to

$68 M over a three year period.

Took charge of a key program of outsourcing in our newly acquired

company. Implemented financial, contract and reporting

outsourcing activities of the key programs allowing for smooth

transition of the program to sanofi pasteur standard operating

processes and procedures.

Developed new Strategic Partnership for services to meet

Regulatory commitments. Led RFI/RFP, evaluation, and selection

process. Including MSA and Charter authoring and rate and term

negotiations

Integrated Outsourcing Activities from acquired organization into

the sanofi Pasteur outsourcing strategies.

Assisted in the renewal process for key strategic partner.

November 2007

to January

2009 Director, Clinical Data Management

M3 Clinical Research, Hinckley, OH

Developed and implemented business development plan for the

Duties: company's Commercial Division. Implement a marketing strategy in

coordination with the parent company's business strategy in the

government sector. Oversee the day to day operations of the

Clinical Data Management department, including the recruiting,

hiring, and training for data coordinators and data managers.

Determine the implementation of regulated and necessary systems

and programs for the operation of the Data Management Department.

Provide leadership to in-house and regionally assigned personnel

who provide CDM services in programs from NIH, US Military

Research Facilities, academic and pharmaceutical clients. Duties

include but are not limited to creation and monitoring the Data

Management Plan, overseeing EDC, and OC studies.

A specific assignment included the evaluation, development, and

implementation of a corrective action plans for the Quantitative

Health Science department's CDMS which was previously deemed

non-compliant by Regulatory and Sponsor Audits.Establish policies

and procedures to enhance SOPs. Reviewed and modified over 500

edit checks that were not properly described or programmed.

Directed remediation of studies that were deemed non-compliant,

including the quality control and training programs, allowing

developers to implement procedures to prevent further deviation

from the plans.

Assigned as a Director Clinical Data Management to the

Quantitative Health Service of the Cleveland Clinic as a

consultant to inspect, review and develop a remediation process

for the installation and implementation of a validated CDMS.

Completed and trained QHS personnel in six months and completed

assignments.

Accomplishment As a result of the remediation process and procedures, all nine

s: studies that had been in a non-compliant status were remediated to

an acceptable status by all clients. The program was completed

eight months ahead of schedule.

Develop submission process for newly developed investigator

initiated studies. Advise Clinic Research Chairman on CDMS

development, requirements, and outsourcing options.

Develop and implement Research Outsourcing and Strategic

Partnership Programs allowing for cost effective and regulatory

compliant trial support to principal investigators and sponsors.

Established and developed evaluation and implementation process

for the installation and use of the OC RDC tool for use by the

in-house teams.

Developed and implemented a Total Quality Assurance plan for a

client that resulted in successfully auditing all vendors for

their drug development program.

August 2007 to Associate Director Operations (Contractor)

November 2007 SDI, Plymouth Meeting, PA

Duties: Directed the design, documentation, testing, and implementation of

clinical data collection studies, and clinical database review.

Collaborated and coordinated with other departments to design and

implement clinical protocols. Directed the implementation of all

study data collection systems. Developed systems for organizing

data to analyze, identify, and report data and trends. Manages

data management issues by reviewing protocols for cross-project

consistency and identifying standard case report from modules to

meet objectives. Developed data quality plans. Responsible for

projects that were contracted to CROs as well as internal

projects. Select, develop, and evaluate personnel to ensure the

efficient operation of all functions. Provided training and

mentorship to staff.

Accomplishment Developed three individual performance improvement plans for

s: employees that were failing to meet the expectations of the

department head prior to my arrival. All three employees

completed their remediation on-time or ahead of schedule allowing

them to return to their teams with the tools they needed to keep

the checks and balances when meeting all tasks that they are

assigned.

Mentored the department head in methods of management that were

less personal to the employee, allowing the manager to improve

communication understanding without losing control of the

situation. Received numerous accolades from executive management

and from Human Resources for the increased productivity and

overall morale improvement while assisting in managing the

department.

Sept 2006 to Sabbatical

August 2007

March 2006 to Director, Clinical Data Management (Oncology)

September 2006 Eisai Clinical Global Development, Ridgefield Park, NJ

Duties: Roles and responsibilities of this position was is to oversee the

day-to-day activities of the Oncology Data Management team.

Including all oncology studies where the data management functions

were being led from the US office. Support the global objectives

of the data management team and all oncology studies. This

included directing studies utilizing in-house systems as well as

CROs and their systems. Developed and implemented reporting

procedures for CROs to report productivity and escalate issues for

resolution. Developed data management techniques and processes.

The clinical development process included IT infrastructure,

knowledge of medical terminology, data acquisition, cleaning and

management techniques.

Accomplishment Developed Bid Costing tool and Bid Analysis tool for Clinical Data

s: Management studies.

Established structure for initiation of third party bids for

in-house studies that were to be outsourced. Assisted in authoring

Charter for Third Party Radiological Reading and Reporting for

pivotal trial. This Charter was submitted to the FDA and approved

on first submission. Managed and led a team of nine Clinical Data

Managers and Clinical Data Analysts. Global Lead Data Manager on

second pivotal trial being run via the UK office. My participation

allowed the aggressive start-up timelines to be met ahead of

schedule.

January 2005 Director, Clinical Data Management

to March 2006 ReSearch Pharmaceutical Services, Plymouth Meeting, PA

Duties: Roles and responsibilities of this position were to oversee the

day-to-day operations of the organization in the area of Clinical

Data Management, Database Administration, and Clinical Database

Programming. Responsible for P&L for the entire CDM Department.

Oversaw the in-house staff working on traditional CRO initiatives,

staff working in satellite office situations for specific clients,

and staff working within client's offices. Teams and individual

direct reports totaling 87 staff personnel. Prepared proposals

for projects to be conducted in the Biometrics and Clinical Data

Management division including project costing, resource staffing,

contract development, project budget development, revenue

predictions and recognition, invoice approval and expense

reporting. Evaluated and proposed new processes and technologies

for increasing efficiencies within the Biometrics and Clinical

Data Management division. Designed and developed an

infrastructure for the Biometrics division of the Clinical Affairs

department. Primary Operations Contact for Business Development

and Marketing functions as they applied to CDM and Biostatistics.

Accomplishment Consultant activities included: Project Director for a Biotech

s: Firm conducting an e-submission, and for a small CRO in the

establishment and development of a Clinical Data Management

Department. This included the implementation of Oracle Clinical

and its EDC tool. Implementation included loading, validation,

and end user verification. Systems validation of the Data Entry

Tool, Edit Program verifications, discrepancy management, and

medical coding tools.

Consulted with a Biotech on consolidating trials that were not

standardized for an ISS and ISE submission of an NDA. Project was

planned to run for Five months but we completed all tasks in 12

weeks. Client submission resulted in an approval of their NDA.

Key person for biotech Business Development management resulting

in signing of one Key Client to an exclusive Preferred Partner

Initiative.

February 2001 Director Business Development & Associate Director - Director,

to January Data Management

2005 ICON Clinical Research LLC, North Wales, PA

Duties: Assigned as Primary Business Development Representative for all US

based Japanese Pharmaceutical and Biotechnology companies. In

this role I developed a Business Plan to access and develop

business relationships with as many companies as possible in the

concentrated area. While in this role, I made numerous contacts.

I developed five firm relationships which resulted in major

projects being awarded and a Preferred Partner relationship with a

company for all services from Project Management through Medical

Writing.

As a Director, this position was to oversee and direct the Project

Planning and Project Resource Management for the Biometrics and

Data Management Divisions within the organization across all US

based offices. Provided strategic planning and implementation of

new and revised processes and systems. Primary support to the

Business Development Department with focus on sales of Data

Management and Statistical service offerings of the company.

Managed and maintained Biometric and Data Management Budget,

Revenue Recognition and Invoicing. Fiscal accountability for a

budget in excess of 20 M dollars in annual revenue.

Assisted in the review of departmental procedures for four Data

Management Processing Centers across the United States.

Took ultimate charge of the data management teams assigned to

clients and their projects in the areas of Resources, Financial,

and Business Development keeping company objective and business

plans in mind.

As an Associate Director, the position responsibilities included

but were not limited to:

Training and monitoring managers and staff personnel in planning,

implementation, and delivery of projects, processes, and

technologies. Directed effective Management,Development and

Appraisal of staff within Data Management teams. Planned,

researched, and implemented new technologies within the business

plan of the company.

Accomplishment Successfully coordinated Full Service sales in excess of fifteen

s: million dollars in a six month period. Developed four Preferred

Provider Relationships with clients who had not previously worked

with ICON. Developed and oversaw the overall efficiency review

and reengineering of all processes within the Biometrics and Data

Management departments on a global basis. Provided guidance to

the Strategic Planning team for the development of a Biometrics

and Data Management Phase IV Peri-Approval Unit within the U.S

Reviewed and audited 12 EDC vendors and recommended to executive

team the systems to be considered for EDC implementation at ICON.

Developed and implemented an accurate and concise Executive

Reporting tool to keep executives in the Operations, Financial,

and Business Development areas of the company informed of

accomplishments and issues that needed attention. During this

period accepted a temporary assignment to oversee the

reengineering and retooling of the Data Management operations in

the Irvine, CA office. This included management, resource

development, training, fiscal evaluation and the development and

implementation of a successful recovery plan. This plan was to be

accomplished over a nine to twelve month period. Due to the

effective implementation of leadership and team building and

process improvement this task was accomplished in six months.

Accepted role of Global Project Director for a 2,500 patient

rescue study that was not meeting timelines and deliverables.

Directed the operations of the project including Project

Management, Site Monitoring, Clinical Data Review, Clinical Data

Management, and Database Administration. Because of my management

and client knowledge, we were able to reorganize the efforts and

close the Clinical Database three weeks early; with quality metric

surpassed and the contract expectation accomplished

satisfactorily. This allowed the client to meet an accelerated

timeline closing the project six months ahead of schedule.

Reviewed and approved all business proposals for projects that

were bid witin the Data Management Department.

Authored, reviewed, and approved appropriate SOPs for Data

Management on a local, regional, and global basis. Reviewed and

maintained all project budgets to ensure that all projects were

delivered on-time, under budget and with the highest quality.

Communicated with clients on a regularly agreed schedule to ensure

that all expectations were met on-time and with the highest

quality.

November 1999 Manager, Data Management

to January Covance Peri-Approval Services Inc., Radnor, PA

2001

Duties: Project operational responsibilities included the strategic design

and implementation of innovative data collection and reporting

systems for Phase IIIB and IV international and domestic clinical

research programs. Coordination of project activities included:

Implementation and maintenance of overall strategic project plan.

This included tracking systems, database structures, quality

assurance systems, and all data collection and reporting systems.

Managed the first RDC trial using the Covance tool developed

internally. Activities included In-line review, query generation,

correction validation, medical coding, and line listing reviews.

Accomplishment Developed of study specific procedures, Monitoring project

s: activities, budgets, and timelines. Ensuring all quality control

processes were applied. Track and maintain study Data Management

budgets. Coordination of project activities to insure the

accuracy and reliability of research databases. Preparation of

all client deliverables, including status reports, interim and

final analyses, physician and patient incentive payments.

Insuring all client deliverables are on time.

Interfaced with the client, inter-corporate divisions of Covance,

all subcontractors, and project teams regarding data management

issues. Supervision and training of data management staff.

Review of RFP and Bid Proposals prior to their submission to the

client. Also provided consistent presentation of the data

management capabilities in business development presentations as

well as client presentations. Worked closely with the directors

of Business Development to ensure data management support was

provided.

July 1996 to From Clinical Data Reviewer to Manager, Clinical Data Management

November 1999 Advanced Biologics LLC, Lambertville, NJ

Duties & Responsible for the overall management of the Clinical Data

Accomplishment Management Department including the Forms Designers, Data Entry

s: personnel, Data Coordinators and Data Analysts. Managing the

database responsibilities for seven Phase II and III protocols and

thirteen data management projects, which included database design,

CRF design, database validation, data entry, data analysis, data

queries and training specific to each project or protocol.

Provided primary support for General Capabilities Presentations

and Bid Defenses.

Additional responsibilities included preparing and presenting CRF

completion instructions at investigator meetings and preparing

written guidelines for CRF completion at the investigational

sites. Responsible for training and certification of all

personnel within the Clinical Data Management Department including

Data Entry, Data Coordinators, Data Analysts, Data Coders, Forms

Designers and Database assistants. Assisted Business Development

with Bid preparation, Capabilities presentations and contracts

reviews.

Senior Clinical Data Analyst

Developed Case Report Forms and Databases. Managed the overall

data input, dictionary encoding, database queries, and resolve

issues with investigative sites. Responsible for maintaining

communications with clinical, biostatistical, safety and medical

writing departments. Worked closely with the medical monitors to

ensure that information was accurately recorded in accordance with

Good Clinical Practices. Completed two databases for NDA

submission. Presented CRF process and Database issues at two

investigator meetings. Revise departmental Standard Operating

Procedures. Trained Data Analysts and CRAs. Primary backup for

the Safety and Surveillance Department in preparing IND safety

reports and writing narratives for multiple studies.

Clinical Data Reviewer

Responsible for the Clinical Data Review of two Phase 1 and one

Phase III trials. Reviewed CRFs, online, creating queries,

encoding Adverse Events and Concurrent Medications. Communicated

with investigational sites to resolve CRF issues. Perform

validation checks for database.

Safety and Surveillance Associate

Received Serious Adverse Event information from investigational

sites. Wrote narratives and communicate with the Safety

Departments of numerous sponsor companies and with the FDA when

appropriate. Queried sites for additional information when

necessary. Developed and maintained company-wide Serious Adverse

Event database and tracking system allowing for accurate reporting

of IND safety report. Authored narratives for several different

ISS reports.

US Naval Medical Service from October 1975 through June 1996

Senior Medical Department Representative (equivalent to civilian PA-C)

United States Navy, Various Global Locations

1989 - 1996 Managed the daily operations of a medical program, which

provided services to over 200 military personnel. Fiscally

responsible for payment and tracking of medical claims,

maintaining medical records and maintaining and updating all

medical databases for all employees. Provided contract medical

management support for 400 Active Duty Navy and Marine Corps

personnel. Responsible for all daily administration and

operations of the office complex. Supervised a staff of 11

personnel. Cited numerous times for outstanding performance and

for outstanding voluntary community support during natural

disasters.

1987-1989 Supervised a two member staff while providing primary care to

students at a Navy Trade School, which taught high-risk

training. Cited for institution and utilization of TQL

principals in establishing AIS programs allowing for safer

training and analyzing potential training hazards. This

initiative was duplicated throughout the Navy's training system.

1980-1987 Supervised 24 health care providers in a primary care setting

with a weekly census of nearly 400 patients. Supervised

technical operations in Medical Administration, Pharmacy

services, Laboratory services and Radiology services, as well as

staffed area for coverage of this seven-day a week operation.

1976-1980 Screen and treat patients in a primary care setting with a

weekly census of nearly 300 patients. Reported directly to the

chairman of the Internal Medicine Department. Provided

emergency room coverage for the Internal Medicine Department as

an on-call provider.

1975-1976 Maintained trial study information for a 1000 subject

vaccination trial. Performed subject questionnaires and

maintained all study files for a one year vaccination trial.

Trial sponsored by the NIH and NIAD

MILITARY AWARDS AND HONORS

National Defense Medal

Good Conduct Award (4 Yr) - 5 Times

Navy Achievement Medal - 3 Times

Military Volunteer Medal

Expeditionary Medal 3 Times

Sailor of the Quarter (4 Times)

Sailor of the Year 1992, 1994

Reserve Good Conduct Award (10 yr) 2 times

Regional Sailor of the year (5 times)

United Nations Service Award

THERAPUTIC EXPERIENCE

Anti-Infective

Anti-Infective -Ophthalmic

Anti-retroviral

Cardiovascular

Dermatology

Endocrine Diseases

Gastrointestinal

Neurology

Oncology

Ophthalmic Device

Reproductive systems

Respiratory

Urology

Vaccine

Vascular Surgery Devices

SYSTEM TECHNOLOGY EXPERIENCE

Oracle Clinical V.3.2 through 4.5

Oracle clinical RDC

DataFax

Clintrial 4.0 & InForm

Medidata

Datalabs

CRF Express

MS Access

SAS Viewer

MS Excel

MS Word

MS Project

WHO DD

MedDRA

Costart

WHOARD

PUBLICATIONS, ARTICLES & PRESENTATIONS

Communications Standards in Practice, AMSUS - June 1994

Standardizing CRF Designs, SCDM March 1999

Enabling the Adult Learner, Co Author B.J. Moore, M.W. Kreuter. DIA June

1999

Teamwork for Success - SMI, London - June 2002

Effective Team Communications - SMI, London - September 2003

Privacy issues US versus EMEA - SMI London - September 2005

PROFESSIONAL AFFILIATIONS

Society for Clinical Data Management - Member 11 years

Drug Information Association - Member 14 years

DIA - CDM (SIAC) - Member

American Red Cross - National Board of Directors - Board Member - Emeritus

Association of Military Surgeons of the United States - Associate Member

References Available Upon Request.[pic][pic]

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