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Manager Project

Location:
Pennington, New Jersey, 08534, United States
Posted:
April 18, 2018

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Resume:

SUMMARY BIO

Keith is a Clinical Operations and Trial Manager professional who has more than 20 years as a project manager in Global Clinical Pharmaceutical industry for a variety of both large and small companies including CROs. He has been directly responsible for the completion of several large and small global clinical research trials and projects that have contributed significantly portfolios and intended pipelines for continued product development and outsourcing. Most of the success was directly related to skills for leading cross functional teams, planning study execution & deliverables, negotiating grants and contract agreements. This includes agreements with Universities and KOLs, Quality and Risk management, management of projects and professionals and a communication network for a variety outside companies and providers. The experience covers the timely management of these projects and contracts with niche providers, outside vendors, CROs and a global network of vendors, manufacturers, and related affiliates and personnel that share in any part of the assigned project. Keith is proficient in all MS applications and all industry based financial processes. Keith holds a BSN in nursing, and an MBA from Rutgers in BioPharma area and is PMP trained.

Skill sets include, study financing, management of industry niche providers, Biologics manufacturers and CROs, study modeling - business plans - profiling - forecasting, risk assessments, FDA standards and sponsor audit readiness procedures, personnel development, management and administration functions - global partnerships and alliances. BSN from Nursing German University; May 1984. Mini MBA for Global BioPharm Entrepreneurship Rutgers, April 2010. PMP training, Avtech Institute of Technology June 2013. Formal Microsoft Applications training, NJ state EMT license & first responder.

PROFESSIONAL MANAGEMENT

oFinance & Budget Management for planned deliverables and timelines

oManagement of Change Orders

oMaster Service Agreements

oContract Negotiations

oNegotiations with Global CROs

oBudget Forecasting including Resource Planning & Analysis

oPayment Schedule Coordination

oFormal PMP training Avtech Institute

oProficient in all Microsoft applications

o Management of Industry Niche Providers – Central Labs / IRBs / CROs/ IVRS & UATs contracts

oSite Contract Negotiations / Payments

oBudgetary Savings and Legal Applications

oContract and Budget Deviations

oCross Comparison of Industry Budget Standards and Services

oTools and Measures Across all Studies for Future Business Planning

oBiosimilar studies and manufacturing supply chain challenges for strength, purity, quality and scale compared to reference product.

CLINICAL OPERATIONS

oCoordinate Clinical Study Reports for NDAs

oProduce and write Top Line Results

oExecutive Summary reports coordination

oMeaningful Resource Allocation Input

oFDA Briefing Books coordination

oDevelopment of Study Specific Documents and Site Materials for study phase I to IV

Protocol / Manual / Study Log

oRegulatory Document Collection

prior to First Patient In

o Ongoing Study Specific Therapeutic

Training of Staff and Site Personnel for Study Start-Up including nonclinical team support, ISS and NIS studies

oInvestigator Meeting Presentations

Study Processes / Methodologies and labeling, Inspection Readiness for sponsors and CROs

oGCP / SOP Training for CRA’s Site Monitoring

oSupervise Study Completion for all study phases

Clean-Up / Reconciliation / DBL

oProvide Operational Leadership for:

Complex Problem Solving Issues Resolution

INTERNATIONAL - GLOBAL RESEARCH

oWorld Wide Distribution of Clinical Supplies / Packaging / Materials

oCustoms Broker Management

oImport / Export Regulations

oOverseas on-site assignments in Holland Germany and Switzerland

oRegulatory Labeling and 21CFR guide lines

oSite Studies Synchronization

oStudy needs for Site Budgeting

oNeeded Critical Document Translations

DATA MANAGEMENT, BIOSTATISTICS AND PROGRAMMING

oStudy Life Cycle Coordination of all data clinical management, transfers functions / activities & data interpretation and statistical results

oBiostatistical Programming Oversight / Development During Creation Phases

oDatabase lock preparations/line listing review

oTesting / Validation of Empty Database including Query Text / Automation and reporting

oCase Report Form Development

Tracking / Entry, full ongoing data review

DRUG SAFETY AND SAE REPORTING

oCoordinate / Train Industry SAE

Reporting Requirement/Standards

oDocumentation and Leadership of Final Safety Database Reconciliation for a CSR

oGlobal Clinical Safety review and continued Product Risk Management and Reporting

o Pharmacovigilance safety Management activities including lab test results and related systems

oIndividual / Executive Summary, write monthly reports for technical complaints, write

SAE narratives for final Study Report Safety Section and AE surveillance, SUSAR follow up and Reconciliation

ACQUIRED PROFICIENCIES

oRx to OTC Switch Formulations Development for study in consumer products venue and commercialization for NIS/IIS trials

oPotential Alternate Use of Other Already Approved Drug and for Modeling of biosimilar awareness, manufacturing and market dynamics in other therapeutic areas

oManagement and Training of Many Regional Home Based CRAs

oDevelopment of Feasibility Questionnaires for Use in Third World Countries

o Management of Large Mega trial

Phase IV Drug Study with Over 500 Sites 12,000 Patients, Study close out for CSR

oDevelopment of Class II Drugs via DEA

oManagement of Single Investigator

IND/IIR Studies, ISS for Publications, compassionate use and registry studies

oMany Direct Overseas Assignments for Management and Coordination of Global Research Projects

THERAPEUTIC AREAS OF EXPERTISE

oCardiovascular, women’s health,

Cath lab studies, HIV, CML/CLL

oInfectious disease, cholesterol studies, Hematology/Oncology studies, DNA sampling and collection

oOncology pain, CML & MM, gastroenterology, psychiatric

oADHD in pediatrics, endocrinology, anticoagulant – DV Thrombosis

anti platelet, class II drugs studies.

SECOND LANGUAGE PROFICIENCIES

oGerman Fluent Written and Verbal

EDUCATIONAL RECOGNITION

oBSN Nursing Certified Registered Nurse, Porz Nursing School Germany 1984

Degree approved by Commission of Graduates for

Foreign Nursing Schools Washington, DC

Mini MBA Global BioPharm Entrepreneurship Program, Rutgers University, NJ 2010

Market Place ideas

Business models

Technology for startups BioPharma business Advance planning

Global partnerships

Intellectual Property (IP)

Strategic marketing

US life sciences market

financial forecasting

Enhanced ability to coordinate clinical research projects and associated relationships for global alliances and partnerships for successful business and commercialization for Consumer Products models and biosimilar awareness and marketing, presented to a VC panel “How BioMarkers and DNA sampling will revolutionize personal health care and is the way of the future for treating physicians using Pharmacogenomics”.

oPMP training at the Avtech Institute of Technology, South Plainfield, 2013

oFormal training in all Microsoft applications at Avtech Institute of Technology

oNew Jersey state EMT license (first responder)

PROFESSIONAL EXPERIENCE and ACCOMPLISHMENTS

Clinical Study/ Project Manager for R&D development (Project Consulting Various Companies); Spring 2010 to Present.

Bristol-Myers Squibb 2-2017 to 10-2017; Clinical Manager/ Site and project management for Multiple Myeloma study indications, using multiple combinations of the current standard of care treatments for all of the US sites. Budgets and accruals forecasting and change order management

Merck 9-15 to 10-16; Clinical Manager/ Quality Control Manager Lead; Prepare and lead FDA pre-inspection readiness for all clinical activities in preparation for pending FDA site and sponsor inspections. Organize and lead all related activities during ongoing Sponsor inspections in the prep-room and staff training for both internal and internal roles including CRO involvement to identify any areas of potential risks to the study.

Johnson & Johnson, Ethicon 2015; Clinical/ Regulatory Project Manager in there CoE. Managed Transfer of legal manufacturer of medical devices including re-registration and certification documentation for and 39 products lines, CAPA processing and follow-up documentation, internal ADAPTIV documentation for Change Projects and eDHF construction with deliverables of regulated project documents.

Bristol-Myers Squibb 2014; Clinical Project Manager/ Vendor and study Management In their Phase IV group, vendor management for global study out-sourcing and CRO RFP development and BID defense meetings review and line item negotiations and clinical input for competing contracts in two therapeutic areas of HIV, second line treatment standard and oncology CML non-inferiority study against the more preferred current treatment standard of care.

Pfizer x 3 2012 & 2013; Clinical Project Manager Project management COL and site monitoring with QC audits for phase I study startup in oncology standard of care treatment and new dosing regimens as specified by the FDA and, 2nd, Sr. Manager Safety Reviewer and medical writer in Global Medical Affairs, 3RD QQI lead for worldwide site and vendor issue resolution, criteria for protocol violations & deviation, CRO monitoring issues including collection of all administrative and documentation placed in the company RT II system.

ShanghaiBio Corporation 2012; product launch for human genome testing practice using Bio-markers and fund raising presentations for venture capitalist for country wide laboratory construction and set up

Bio Mantra Corporation 2011; Prepared and presented multiple project presentations for an Indian Based company on regulatory affairs submissions, clinical feasibilities, vendor and CRO management, site selection, training and monitoring for a variety of OTC products commonly used for generations in India. ShanghaiBio Corporation; product launch for human genome testing practice using Bio-markers and fund raising presentations for venture capitalist for country wide laboratory construction and set up

Nextwave Pharmaceuticals 2010; development of Protocol documents, CRFs, consent forms, manuals, logs, amendments and long term CRO and data management outsourcing contracts for pediatric CNS studies

Novartis Pharmaceuticals Corp.

East Hanover, NJ,

Expert Clinical Project Manager Consultant,

April 2008 - December 2009 (after one contract extension, contract ended)

Primary responsibilities were to coordinate and chair the completion and close-out of all study related data management activities for an NDA of an international mega trial in acute care Hypertension with 556 sites and 11,505 patients. This included a full safety reconciliation between clinical and the drug safety division for a full FDA clinical Study Report NDA submission

Provided leadership for a full review and reconciliation of all safety related data between Clinical and the Safety Group, all draft tables, listings and figures in preparation for data interpretation & DBL to be included in the regulatory NDA filing

It also included the financial reconciliation and budget management of all outside vendors; i.e. two international CROs, central labs, central IRBs, clinical drug supply reconciliation with two vendors, and a variety of consulting contracts. Coordinate annual safety update for FDA submission.

To provide operational and team leadership for the NDA submission including motivation, construction, makeup, medical education and training of staff and feedback of a full Clinical Study Report and data interpretation and analysis written by outside vendors according to current company template forms, SOPs, publishing criteria and regulatory requirements using the new FDA Electronic Submission Gateway, ESG for a regulatory NDA submission

Additional responsibilities were to support and write core study documents as protocol amendments, consent forms, feasibility questionnaires and pharmacy manuals for a hypertensive study in pediatrics for 6 month to 5 year old children as requested by the EC and FDA.

Ortho-McNeil Janssen Scientific Affairs,

LLC, Titusville NJ,

Clinical Project Manager Consultant,

July 2007-April 2008 (after one contract extension, contract ended)

Primary responsibilities were to provide the operational expertise for the wrap-up of all clinical operations and database functions for the DBL of a phase IIIb psychiatric bipolar study to support a regulatory sNDA submission to the FDA.

To chair and provide leadership for the financial reconciliation of five different outside vendors, two CROs with multiple contract revisions currently in progress, review of all database related queries and biostatistics programming, network communications to the outside public of the positive study results, gantt charting, coordinate the executive summary, top line results and the development of the FDA briefing book with multiple outside vendor’s and medical writers.

Further coordination of the Clinical Study Report including a full QC/QA of the tables, listings and graphs, additional ad hoc summary tables and full internal safety reconciliation including development of comprehensive SAE patient narratives for the actual sNDA

Grunenthal USA, Aachen Germany and Bedminster, NJ,

Clinical Study Manager,

September 2006 - April 2007 (studies did not get approval in the US and PM moved overseas)

Primary responsibilities were the logistical set up of an action and resource plan with outside

vendors for the administration of a novel new opioid study to be used in specific cancer patients on three continents, North America, South America and Europe.

Contract negotiations with many niche providers for IVRS, Central Lab, Central ECG, Central IRB, Invivodata, Allmac Packaging and clinical supplies management and distribution, Pharmlink Consulting, two CROs, contractors and other Personnel management firms.

Other responsibilities were SOP development, IOP development, Import/Export regulations and feasibility coordination and distribution for site training and country selection between a geographically diverse team.

The Medicines Company, Parsippany, NJ,

Clinical Project Manager,

June 2003 - September 2006

(left due to company instability)

Primarily responsible for the management, development and execution of up to 15 acute care Cath Lab based phase IIIb/V publication studies using the anticoagulant Angiomax.

These acute studies included PCI short and long term outcomes compared to the standard of care of Heparin in combination with a GP IIb/IIIa.

The timely completion and subsequent publication of the results was important while keeping up with the evolving technology being developed in the Cath Lab.

I was also responsible for developing good business relations with key opinion leaders and outside vendors in the industry that lead directional changes in the Cath Lab.

I worked very closely with our publication department, data management, finance, biostatical, legal, drug safety, regulatory and senior management to identify which proposals warranted further consideration and funding.

Created and managed a clinical supplies pool to support multiple single investigator IND studies in compliance with OIG regulations.

Ingenix Pharmaceutical Services, Basking Ridge, NJ

June 2000 – June 2003

Primarily responsible was for the management, execution and staff and site training of multiple research projects for a variety of pharmaceutical companies in Cardiovascular and Endocrinology therapeutic areas for phase II, III and IV studies.

Also made proposal and presentations to potential pharmaceutical clients on internal capabilities, operations and procedures to gain new work orders.

Clinical Research Associate Manager,

Quintiles, Advance Phase Solutions, Cranford, NJ

November 98 - June 2000

Primary responsibility was to manage 35 CRAs regionally based across the country, which

included any and all personnel, human resources, promotions, medical education, salary and hiring issues.

Additionally, I managed three ongoing research projects in Oncology, Hematology and

Gastrointestinal therapeutic areas including timeline development, budgeting, protocol and

CRF development, database setup and staffing.

Other areas of responsibility included working with financial development and forecasting, business development for future projects, client contact satisfaction, organized and implemented several key internal organizational programs to better help administrate the department.

Clinical Research Consultant Manager,

October 1996 - November 1998

Projects included site management, data collection, grant negotiations and payments, preparations

for FDA and QA audits, adverse event reporting, global clinical supplies management and distribution, medical education and training, site closeouts and final study reports for

anti-cholesterol drug in phase II development and the management of Rx to OTC switch studies using different formulations.

Data review and cleanup in preparation for data lock for a worldwide study of Schering Plough’s cardiovascular platelet inhibitor drug based in Rotterdam, Holland.

Roche’s global development program for studies of a novel cardiovascular drug, endothelin

antagonis based in Basel, Switzerland. Alteon’s data cleanup for a new diabetic drug.

Administrative study startup work for Innovex’s pain studies and pre-study visits for a Class II drug development program.

Sandoz Pharmaceutical Corporation,

Clinical Research Associate II,

East Hanover, NJ

Cardiovascular Department - January 1991 - October 1996

Primary responsibility was the management of all existing clinical data and review of all statistical listings for the Fluvastatin Rx to OTC NDA submission planned for the 4th quarter 1992.

Other responsibilities included the monitoring of three different research protocols on an RDE

system and the development of new data collection methods involving a Co A reductase inhibitor (anti-cholesterol drug).

In addition, trained other research consultants and study coordinators, identified new investigators, negotiated and tracked clinical grants, budgets and contracts, collection of regulatory documents, coordinate investigator meetings, study reports and new protocols.

Ortho Pharmaceutical Corp, Biotech Div.,

Raritan, NJ

Clinical Research Associate,

May 1986 - January 1991

Responsible for multiple research sites conducting clinical studies using recombinant human Erythropoietin for several anemia indications.

Organized and started up multiple sites for several different protocols for pre-dialysis, frank AIDS, and HIV - indications.

Additional responsibilities were all study related administrative documentation, i.e., research grants and budgets, site and in-house study files and all FDA documentation.

Monitored all aspects of ten different protocols.



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