Project Manager Management
Resume:
Chris Merriam-Leith, MS, PMP, RAC
*************@*****.***
[pic]
SUMMARY OF SKILLS:
. 17 years as a Consultant and Project Manager within the Biotech,
Pharmaceutical industry
. Demonstrated success in driving change and continuous process
improvement in support of global operations.
. Has successfully led high-performance teams with a demonstrated
success in meeting and creatively solving complex business and
regulatory challenges.
. Solid experience as a consultant developing clinical trial processes
and systems and clinical research operations.
. Understanding of CDISC, eCTD, ICH and other standards
. Strong understanding of Quality Management System (QMS) regulations,
GCPs, GMPs, and GLPs
. Executed QMS / SOP validation requirements for GCP, GLP, cGMP and 21
CFR Part 11.
. Experience drafting QA validation scripts for FDA QMS compliant
systems.
. FDA QMS validation experience (IQ, OQ, PQ) with clinical,
manufacturing systems and LIMS.
. European Union Commission Annex 11, Annex 15, and ISO 9001 compliant
systems and business processes
. 15 plus years' experience with clinical system technologies.
. Experience developing detailed project plans and work schedules to
meet FDA regulatory requirements
. Experience allocating tasks to project team and monitoring quality and
timeliness of required deliverables
. Experience tracking key regulatory milestones and adjusting plans
and/or resources to meet regulatory requirements
. Experience with setting appropriate priorities assigned to critical
regulatory tasks
. Experience with communicating regulatory status and issues for
resolution to appropriate steering and oversight committees
. Experience with managing regulatory direction to ensure that Senior
Management Executives expectations are managed
. Experience with managing regulatory scope through tight control
procedures
. Experience with monitoring project costs to ensure budget adherence
. Experience with performing quality reviews and escalating project
issues as appropriate
. Experience with working with the QA teams to ensure that compliance
requirements are met
. Experience with coordinating the Project Management responsibilities
for related initiatives to manage cross-project dependencies
. Experience with issue resolution and appropriate issue escalation
. Experience with managing for gaps, issues, and risks
. Able to document and lead lessons learned following project completion
and shares results with management
. Able to provide team leadership and team building
. The ability to manage 1-3 large projects of diverse scope across
functional areas or multiple products
PROJECT MANAGEMENT
. Strong verbal and written communication skills.
. Expertise using structured PM methodologies processes and tools.
. Experience w/ MS Project Professional, MS Office Suite and Visio.
. Excellent facilitation, planning, organizational, and coordination
skills.
. Solid experience managing multiple, large-scale projects
simultaneously.
. Effective conflict resolution skills.
. Assertive enough to focus and lead projects, but who is not too
aggressive
. Relationship builder - polite, collegial and professional
. Attention to detail
. Ability to meet the budget and schedule for the project, as well as
manage the project plan.
. Solid experience working as a consultant with fortune 500 clients.
EDUCATION:
M.S. Regulatory Affairs of Drugs, Biologics, and Medical Devices,
Northeastern University
B.S. Business Administration, California State University Northridge
PMP - Project Management Certified, Project Management Institute
RAC - Regulatory Affairs Certified, US and Global, Regulatory Affairs
Professionals Society
Masters Program Work:
. Introduction to Drug and Medical Device Regulation
. Validation and Auditing of Clinical Trial Information
. Human Experimentation: Methodological Issues Fundamental to
Clinical Trials
. New Drug Development: A QA Regulatory Overview
. Biologics Development: A QA Regulatory Overview
. Biomedical Product Development: From Biotech to Boardroom to Market
. Medical Device Development: A QA Regulatory Overview
. Food, Drug, and Medical Device Law: Topics and Cases
. Managing International Clinical Trials
. Regulatory Writing: New Drug Applications
Masters Research Project:
Design and Development of Clinical Trial Management Systems (CTMS) and
Data Management Practices
MOST RECENT PROJECTS:
Some project dates overlap as a result of consulting on multiple projects
during the same time period.
Employer: LRRI Oct 2010
to Jan 2014
Title: Senior Director Business and Regulatory Affairs
Regulatory Affairs - Developed and implemented policies, procedures and
SOP's related to FDA, NIH, and DHHS regulatory requirements. Responsible
for the oversight and implementation of GCP regulatory requirements for
clinical studies involving human subjects. Responded to any regulatory
audits and inspections and then implemented and oversaw any Corrective
Action Preventative Action (CAPA) plans. Responsibilities for
implementing new QMS business processes and improving existing operations
related to GCP and GLP practices. Reviewed and implemented GCP
requirements related to HIPAA and HITECH regulations. Performed audits
and reviewed existing practices and procedures related to Protected
Health Information (PHI) and privacy requirements. Assisted the animal
care staff with interpreting and implementing USDA animal welfare
regulatory requirements. Reviewed and assisted with the implementation
and application of IACUC requirements. Support executive management with
the implementation of organizational wide regulatory requirements.
U.S. FDA - Responsible for the communications with the FDA and DHHS and
other regulatory agencies. Generated and responded to correspondence from
regulatory authorities. Developed and maintained relationships with
regulatory agencies such as FDA, NIH and DHHS. Provided support as a
contact between any business units and any regulatory agency that
involved a compliance related issue.
Compliance - Reviewed the details of any financial conflicts of interest
(FCOI's) for any Principle Investigator involved with a clinical study.
Responsible for reviewing any claims of research misconduct related to
any DHHS funded projects or GLP clinical studies. Drafted informed
consent forms, risk mitigation plans and business associate agreements.
Reviewed protocols, data and reports to ensure the clarity, consistency,
and conformance to regulations, guidelines and regulatory strategy as
well as suitability for submission to regulatory agencies.
Project Management - Provided regulatory management and leadership to the
clinical and research organizations for the development and
implementation of regulatory strategies and processes to gain regulatory
approvals. Responsible for keeping the management team informed of any
significant regulatory related issues.
Manage various projects within established scope, schedule, and budget.
Developed and implemented high-level strategies for accomplishing
specific project objectives. Facilitated and lead project meetings,
managed change and conflicts, and developed resource planning estimates
to manage project workload and productivity. Provided support to the
project management team members to ensure the success of projects while
maintaining strong customer service focus. Assisted with implementing
operational requirements for compliance tracking and records management,
business process analysis. Supported principle investigators (PI's) with
the review of Material Transfer Agreements (MTA's) for the transfer of
Biologics between companies. Negotiated and drafted CRADA's between LRRI
and the NIH and the Harvard Medical School.
Client: Novartis Sept
2009 to Nov 2009
Title: Project Manager / Consultant
Project: Multiple Projects
Worked as an Project Management resource on multiple projects by
assisting internal internal resources with project management
responsibilities during peak project overload phases
. Assisted with the final implementation of the Analytical Workflow
Management System. Coordinated final phase of infrastructure build
and the scheduling for implementation at Emeryville site.
. Assisted with the final deployment of Tibco Spotfire Enterprise
Business Intelligence & Analytics Applications to Emeryville site.
. Initiated and assisted the infrastructure team with a Network
Detransformation Project. Developed project scope statements,
project charter, and initial project schedules. Worked with
external vendor British Telecom to refine SOW and project
requirements statements. Transitioned project to internal team.
. Initiated and assisted with the Compound Management Project. Worked
with internal resources to develop project proposals, scope
statements, scheduling of vendor product demos and internal
communications.
Client: Elan Pharmaceuticals Apr 2008
to Mar 2009
Title: Project Manager / GCP Regulatory Consultant
Project: Multiple Projects
Worked as the regulatory Project Manager and the senior developer on
multiple projects
. Project Manager for the Implementation of a GCP compliant Clinical
Study - Move-IT DMZ, Secure FTP System. Coordinated the activities
with Wyeth to develop and implement new business practices.
Required validation and compliance with 21 CFR Part 11, Digital and
Electronic Signatures.
. Developed SOP's for transfer of Clinical Data between Wyeth and
Elan within QMS standards.
. Developed GCP compliant file transport process for Clinical Data
. Managed the development and implementation of 3 pre-clinical GLP
research applications that included the development of a Plasmid
Tracking management system, a Monoclonal / Polyclonal Antibody
Tracking System and a Cell Line Tracking System.
. Developed detailed project schedules and allocated tasks to project
team members while monitoring quality and timeliness of required
deliverables.
. Perform project estimates, forecasts and tracking for project
financials and reporting.
. Reviewed, consolidate and disseminated risks, issues, changes and
key dependencies across projects and then monitoring their
mitigation and resolution.
. Monitored IT Project Lifecycle methods to ensure that the chosen
process is followed appropriately.
. Project Manager for the Implementation of Symyx - Isentris small
molecule query database management system.
. Project Manager for onsite domestic vendor team - Symyx.
. Facilitated 30 business modeling sessions with end users to design
3rd normal form relational models.
Client: Genentech
Title: Project Manager / GLP Regulatory Consultant
Project: Transgenic Laboratory Information Management System (LIMS)
Nov 2004 to Aug 2009
Worked as the Project Manager and consultant on multiple GLP compliant
projects
. Performed Business Analysis, conducted JAD sessions, performed
business modeling, designed and built logical and physical database
models,
. Using agile methods developed user interface and reports, developed
system to system interfaces.
. Implemented advanced security and encryption technology, bar code
technology, genetic pedigrees.
. Designed and developed GLP compliant relational database schemas
for LIMS systems that included the development of a transgenic
animal management database system, and colony management system.
. Facilitated 20 business modeling sessions with end users to design
3rd normal form relational models.
. Project Manager for the implementation and integration of the
Laboratory information management system.
. Perform project estimates, forecasts and tracking for project
financials and reporting.
. Reviewed, consolidate and disseminated risks, issues, changes and
key dependencies across projects and then monitoring their
mitigation and resolution.
. Monitored IT Project Lifecycle methods to ensure that the chosen
process is followed appropriately.
. Technologies: Oracle 9i. Toad, MS Access 2002. Visio 2002, Visual
Basic for Applications. DAO, ADO.
Client: Takeda Pharmaceuticals
Title: Project Manager / GCP Regulatory Consultant
Project: Clinical Study Drug Product Tracking System
Mar 2007 to July 2007
Worked as the Project Manager on a Trackwise and GCP - Clinical Trails
Materials Tracking System. The client had a need to automate the tracking
of clinical trial materials and their associated extension dates. Capture
and manage key data related to packaging, labeling, and kitting of
clinical trial materials. Improve the identification and tracking of
clinical trial material review dates materials released by the Quality
Assurance department. Create and track the Blinded Clinical Study
Tracking numbers.
. Designed a QMS - Clinical Trail Materials Tracking Process and
System to integrate with Trackwise.
. Integrated with and validated Trackwise interfaces and processes
under QMS requirements.
. Performed a formal GCP systems validation process of IQ/OQ/PQ for
FDA 21 CFR Part 11.
. Performed GCP data migration and FDA validation of QMS regulated
clinical trials data
. Facilitated 15 business modeling sessions with end users to design
relational models.
. Performed Business Analysis, conducted JAD sessions, performed
business modeling, designed and built logical and physical database
models,
. Using agile methods developed user interface and clinical tracking
reports, developed system to system interfaces.
. Performed Business Analysis, Business Process Modeling, Conducted
JAD sessions, performed business modeling, designed and built
logical and physical database model, developed user interface,
. Hosted applications on internal cloud physical and virtual servers
using MS Server 2003 with Citrix Winframe.
. Technology: MS Project, Oracle, MS Access, Citrix, Visio, Visual
Basic for Applications, DAO
Technology: Oracle 10g, MS Access 2003. Citrix, Visio 2002, Visual Basic
for Applications, DAO
Client: Biogen Idec
Title: Project Manager / GMP - GCP Regulatory Consultant
Project: GMP - Monoclonal Cell Culture Bioreactor Manufacturing Process
System Jun 2006 to Dec 2006
Assisted in the implementation of the Aegis Discoverant Software to
capture data from a Monoclonal Cell Culture Bioreactor manufacturing
process
. Implemented multiple versions of Oracle RDBMS, 9i, 10g.
. The project required an understanding and knowledge of 21 CFR Part
11, FDA Regulations, and GxP Standards.
. Designed and implemented detailed processing workflows using batch
manufacturing processes
. Performed a full GMP, and GCP QMS systems validation process
IQ/OQ/PQ.
. The system integrates powerful statistics, graphics, and visual
analytics to provide direct, read-only access for real time
analysis of process manufacturing data.
. Required a full ETL process to integrate and map operational data
between several existing systems that included a LIMS, PI, SCADA,
EBR/MES, ERP and data input from manual batch records.
. Technologies: Oracle 8.2, 9i, and 10g, Toad, MS Access 2002,
Discoverant
Client: Sanofi Aventis
Title: Project Manager / Consultant
Project: Transgenic Laboratory Information Management System (LIMS)
Sept 2002 to May 2005
Worked as the regulatory Project Manager and the senior developer
. Designed and developed relational database schemas for a Laboratory
Information Management System (LIMS).
. Facilitated 25 business modeling sessions with end users to design
3rd normal form relational models.
. Project Manager for the implementation and integration of the
Laboratory information management system.
. Performed Business Analysis, conducted JAD sessions, performed
business modeling, designed and built logical and physical database
models
. Using agile methods developed user interface and reports, developed
system to system interfaces.
. Perform project estimates, forecasts and tracking for project
financials and reporting.
. Reviewed, consolidate and disseminated risks, issues, changes and
key dependencies across projects and then monitoring their
mitigation and resolution.
. Monitored IT Project Lifecycle methods to ensure that the chosen
process is followed appropriately.
. Technologies: Oracle 9i. Toad, MS Access 2002. Visio 2002, Visual
Basic for Applications. DAO, ADO.
Client: Mentor Pharmaceutical Corporation
Title: Project Manager / Developer / GMP - GCP Regulatory Consultant
Project: Clinical Study Tracking System
Nov 2001 to March 2004
Worked as the QMS regulatory Project Manager and the senior developer
. Designed and developed relational database schemas for a Clinical
Study Tracking System.
. Facilitated 15 business modeling sessions with end users to design
3rd normal form relational models.
. Performed Business Analysis, conducted JAD sessions, performed
business modeling, designed and built logical and physical database
models,
. Using agile methods developed user interface and reports.
. Technologies: MS SQL Server 2000. MS Access 2002. Visio 2002,
Visual Basic for Applications. DAO, ADO.
Client: Mentor Pharmaceutical Corporation
Title: Project Manager / GMP - GCP Regulatory Consultant
Project: Adjunct Clinical Study System
Feb 2002 to May 2003
Worked as the regulatory Project Manager and the senior developer on 20
year clinical study tracking system
. Designed and developed relational database schemas for a Breast
Implant Adjunct Clinical Study Tracking System.
. Performed data migration and conversion of regulated clinical trial
data
. Facilitated 20 business modeling sessions with end users to design
3rd normal form relational models.
Client: Exelixis Biotechnology Corporation
Title: Project Manager / GLP Regulatory Consultant
Project: Transgenic Laboratory Information Management System (LIMS)
Dec 2003 to July 2004
Worked as the regulatory Project Manager and the senior developer
. Designed and developed relational database schemas for a Laboratory
Information Management System (LIMS).
. Facilitated 20 business modeling sessions with end users to design
3rd normal form relational models.
. Project Manager for the implementation and integration of the
Laboratory information management system.
. Performed Business Analysis, conducted JAD sessions, performed
business modeling, designed and built logical and physical database
models
. Technologies: Implemented database design on Oracle 9i.
Client: Mentor Pharmaceutical Corporation
Title: Project Manager / GMP - GCP Regulatory Consultant
Project: Patient Services System
Sept 1997 to Nov 1999
Project: Brachytherapy Inventory System
Aug 1998 to May 1999
Project: Business Planning System
Mar 1998 to Apr 1999
Project: QRIS Customer Lead Tracking System
Oct 1999 to Nov 1999
Project: Legal System Data Conversion to SQL Server:
July 1999 to Oct 2000
Project: Product Management System: Sept
1999 to May 2000
Developed Brachytherapy Inventory System. Developed Patient Services
System. Business Planning System Conducted series of 10 to 15 JAD
Sessions performed business modeling, for user group ranging between 3 to
15 members. Extracted requirements for system design. Used CASE tool,
Iterative Prototyping Techniques. Designed, Developed, Tested,
Implemented, and Trained.
Performed business systems analysis, conducted JAD sessions, performed
business modeling, designed and built logical and physical database
model, developed user interface.
Client had an outdated Legal and Litigation Tracking System. They had
purchased a new application that would replace the legacy system. They
needed all of the historical data migrated to the new system.
. Performed GCP data mapping and ETL of legacy data.
. The new system was relational based and therefore all of the
Primary and Foreign Keys had to be set during the ETL process.
Client: Health Net Corporation
Title: Project Manager / Regulatory Consultant
Project: Physician Profile Reporting System
July 1996 to Aug 1997
Project: G/A Cost Allocations System Aug 1998
to May 1999
Developed Cost Allocation System. Developed Physician Profile Reporting
System. Developed PMG Key Indicators Reporting System. Developed
Physician Member Access Reporting System. Imported data from various
legacy based mainframe systems into PC based MS Access Database System.
Created multidimensional OLAP analysis within the relational model. Used
VBA, and DAO. Each system was very mathematically intensive.
Developed Remote Customer Order Entry System. Using MS Access 95
developed client/server application that was used to transmit orders from
40 remote laptop systems. Data was replicated from the laptops into a
centralized Win NT Server at company headquarters. Once data was
consolidated it was then uploaded into an IBM AS400 for processing. Used
RAS, Replication, DAO, EDI. Assisted with the design of the LAN, Shiva
Communication Server and Client/Server architecture.
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