Michelle Lynn Mucha

1714 Memphis Street, unit 408

Philadelphia, PA 19126
(c) 215-863-1733
HYPERLINK "mailto:mmf1533a@westpost.net" mmf1533a@westpost.net
OBJECTIVE AND OVERVIEW:
Research professional with ~ eleven (11) years of experience seeking management
role within clinical research development/operational organization. Extensive e
xperience managing headcount, budgets and accruals, generating and reviewing Req
uest for Proposals (RFPs) and facilitating RFP defense meetings; experience mana
ging up to nine (9) FTEs (in-house and regionally placed); strong communication
skills and cross functional management skill set. Domestic and International tr
ial management and execution experience Phase 1 -4 (device and GCP); hands-on ex
perience in protocol writing, execution, site management and Trial Master File c
reation and oversight. Consumer product experience (Strategic Safety and Pharma
covigilance Management, Recall Support, regulatory body/congressional hearing su
pport). Direct technical writing experience as follows: Clinical Study Reports
(full and abbreviated), IND filing, Annual Updates, Clinical Development Plans a
nd Clinical Protocols (GCP and GLP)/ICFs, Summary of Pharmacovigilance Systems.
Above average proficiency in excel, MS Project, Access, PowerPoint, Word, Visio
and Outlook.
WORK EXPERIENCE
Johnson & Johnson
Placement by Kelly Services
01/09 current
Senior Project Manager, Office of Safety & Toxicology, Fort Washington, PA
Operational management of departmental budget, headcount and resourcing for Offi
ce of Safety & Toxicology; operational lead for all Recall-related activities: t
imeline, reports, updates and FDA commitments
Identifies resources needed and assigns individual responsibilities, as needed
Operational support for regulatory inspections, filings and responses
Vendor management; inter-company services and external vendors (eg, analytical d
atabase vendor for Pharmacovigilance analyses)
Supports due diligence efforts to explore and identify alternative, cost efficie
nt, sustainable product vigilance solution for consumer products
Creates and executes project work plans and revises, as appropriate, to meet cha
nging needs and requirements
Manages day-to-day operational aspects of departmental projects, scope and budge
t
Management and oversight of document repository and filing
Product recall support: Adverse Event (AE) data analyses and support for recall-
related activities (all products), data quality checks (QC), report review, pre
sentation preparation, BRM database query management
Responsible for QC processes and documentation surrounding data, data analyses
and reports pertaining to safety
Senior Project Manager, Office of Safety & Toxicology, San Francisco, CA Home Of
fice
Authorship of Summary of Pharmacovigilance Systems for MHRA submission; managed
revisions and updates through submission
Update and generate SOPs under new operating model for the Consumer Organization
with McNeil Consumer, as it pertains to the Office of Safety and Toxicology and
Benefit Risk Management; approximately 10 SOPs to date
Generation, management and review of process flows and documents for new, update
d and/or ongoing Pharmacovigilance processes
Pilot and led user testing for new ePortal Repository for Investigator Initiated
Studies within the Johnson & Johnson Consumer Group of Companies
Clinical Operations Consultant for Advanced Clinical Services
12/08 12/09
Revance Therapeutics, Inc.
Placement by Advanced Clinical Services (ACS)
Clinical Team Lead for sponsor company in Bay Area; cosmetic dermatology program
Operational management of four (4) dermatological clinical trials and study team
s in cosmetic dermatology
Site monitoring of one (1) local Key Opinion Leader (KOL) in the San Francisco a
rea
Execution of all operational deliverables, including but not limited to, program
and team management, Case Report Form (CRF) design, data listing review and rec
onciliation, query management, site monitoring, protocol development, regulatory
submission updates, Informed Consent generation, IRB submission for all central
sites, maintenance of Trial Master File, Standard Operating Procedure (SOP) wri
ting, ClinicaTrials.gov postings for all Phase 2 studies
Clinical support for End of Phase 2 filing with FDA
lan Pharmaceuticals, Inc., South San Francisco, CA
05/08 12/08
Senior Clinical Trial Manager
Project Lead on large Phase 3 Alzheimers Disease program (2 protocols); responsi
ble for CRO and operational management of program, reporting structure for Five
(5) FTEs
Project Lead for 2 additional clinical programs; Phase 1b oncology, Phase 3 GI g
lobal program; including program budget, headcount resources and project plannin
g/global feasibility; management of Clinical Trial Specialists
Execution of all operational deliverables, including but not limited to, program
and team management, Case Report Form (CRF) design, data listing review and rec
onciliation, query management, site monitoring, protocol development, regulatory
submission updates, Informed Consent generation, IRB submission for all central
sites, maintenance of Trial Master File, Standard Operating Procedure (SOP) wri
ting
Coordinated the preparation of study budgets (Grant Plan)
Operational management and execution of global Investigator Meeting (3 meetings)
Managed the overall Investigational product accountability and reconciliation pr
ocess
Oversaw and monitors work done by CROs, central labs and other vendors chosen fo
r clinical development activities ensuring delivery against contract
Operational lead for global Phase 3 gastro feasibility, proposal and executive m
anagement review for label expansion
Participated on Business Practice (BP) Initiative; author of 3 new BPs
Operations representative on CTMS Committee
Laid off in December of 2008; 70% of company released during phased lay offs
Genentech, Inc., South San Francisco, CA
04/07 05/08
Clinical Trial Manager
Performed job duties independently with minimal guidance from the Clinical Progr
am Manager
Led the Protocol Execution Team (PET) to ensure that trial timelines, costs, and
quality metrics are met
Served as primary contact for functional area representatives in managing protoc
ol execution for domestic and rest of world (RoW) programs
Ensured accuracy and timeliness of vendor and site payments
Oversaw forecasting of clinical/non-clinical supplies
Established study milestones and ensures accurate tracking and reporting of stud
y metrics
Managed trial-specific Genentech collaborations with other research entities (e.
g., Cooperative Group Trials, Investigator Sponsored Trials, Global Partner Tria
ls)
Performed ongoing vendor management (e.g., CROs, IVRS, Reading Centers), includi
ng independent negotiation of vendors scope of works and budgets, performance ma
nagement, and issue resolution
Created and manages clinical trial budgets and staffing/resourcing plans
Provided study-specific direction and mentoring to Clinical Site Managers, Clini
cal Trial Associates and support staff as appropriate
Provided support and mentoring to other Clinical Trial Managers
Ensured trial adherence to ICH/GCP/local regulations
Participated in clinical operations initiatives and programs as assigned

Hospira, Inc., Lake Forest, IL

10/05 04/07
Sr. Manager, Global Medical Operations (05/06 04/07)
Ensured that all the functional areas in Global Medical Affairs including: Drug
Development and Medical Services, Device Development and Medical Services, Medi
cation Management Clinical Operations and Training and Compliance plan for and o
perate within budget
Oversaw the tactical execution and timely completion of clinical studies and wit
hin budget
Responsible for the tactical execution of animal/clinical studies within budget
and on schedule; ensure global compliance with applicable GLP/GCP/ICH guidelines
and regulations
Assured that project team is adequately resourced, recommends priorities and rai
ses issues to the appropriate level of management
Accountable for managing departmental budget, space and capital equipment requir
ements; ensure that the department operates within budget and within headcount a
s approved in Plan or Update
Spearheaded initiative to define the collection, processing and management of AE
and SAE identification, reporting and planning from the clinical team to the Sa
fety Organization to ensure timely reporting to Safety Agencies
Clinical liaison between Hospira Safety and CRO Safety; assisted in the developm
ent of the Safety Plans and parameters for Safety Databases
Point person for the escalation of AE and SAEs from investigative sites to spons
or Medical Director and other appropriate cross functional team members; ensure
appropriate communication regarding each event
Spearheaded initiative to capture protocol deviation and waivers to Inclusion /
Exclusion criteria via the CRF
Assisted in the review and assessment of product severity assessments, under the
management of Associate Medical Director, for device development
Responsible for nine (9) direct reports as of 2006 June
Clinical Project Manager (10/05 05/06)
Assumed lead role in project planning for assigned studies to include assessment
of clinical team headcount, project timelines and effective utilization of budg
et
Execution of all operational deliverables, including but not limited to, project
and team management, Case Report Form (CRF) design, data listing review and rec
onciliation, query management, site monitoring, protocol development, regulatory
submission updates, Informed Consent generation, IRB submission for all central
sites, maintenance of Trial Master File, Standard Operating Procedure (SOP) wri
ting
Management of Clinical Research Associates to include project assignment, profes
sional development, performance management, coaching and mentoring
Effective communication of project related information including the planning an
d execution of meetings and presentations
Managed outsourcing activities including Clinical Research Organizations, vendor
s and consultants, which includes review of proposals, contracts and budgets (in
cludes ex US bids)
Clinical liaison between Sponsor Safety and CRO Safety; assisted in the developm
ent of the Safety Plans and parameters for Safety Databases
Point person for the escalation of AE and SAEs from investigative sites to spons
or Medical Director and other appropriate cross functional team members; ensure
timely communication to team for each event
Assisted in the review and assessment of product severity assessments, under the
management of Associate Medical Director, for device development
SCIREX Corporation, Bloomingdale, IL
09/04 10/05
Project Manager; new onset epilepsy study / Project Manager; pediatric epilepsy
study
Project Lead for large scale, Phase IIIb and Phase II epilepsy projects
Managed six (6) Regional Clinical Research Associates (CRA) and two (2) Adminis
trative Assistants
Informed Consent Form and Assent generation (4 total) per client and protocol pa
rameters; minimum 2 drafts per document
Budget negotiations, per client guidelines
Worked closely with Medical Monitoring, daily (CRO and client Medical Monitoring
) to assess subject eligibility, waivers, violations and safety-related events,
i.e., out of range labs, event reporting
Approved protocol waivers regarding inclusion / exclusion and visit windows, und
er supervision of Medical Monitor, when needed
Daily project management of study, sites and client, SCIREX core departments, CR
As
Site monitoring as required
Developed and monitored Clinical, Monitoring and Recruitment Plan for projects a
nd sites
Essential document review and approval
Drug release tracking and oversight
Amendment writing for new onset epilepsy study
Informed Consent review and revisions; site specific as per current Package Inse
rts for Local IRB requests
Manage timelines and client goals via close relationships with Statistics, Data
Management and Medical Monitoring
Reported monthly revenues and projections to upper management
Completed employee reviews
Developed Action Plans / Development Plans when appropriate
Facilitated indication training on an as needed basis
Vendor management i.e., Central Lab, CRF vendor, IRB(s)
Trip Report review, approval and version control per SCIREX Standard Operating P
rocedures (SOPs)
Expense Report review and approval
Liaison between Sponsor Safety Team and CRO Safety; assisted in the development
of the Safety Plan
Participated in the reconciliation of CRO and Sponsor Safety Databases; final an
d interim analyses
Point person for the escalation of AE and SAEs from investigative sites to spons
or Medical Director and other appropriate cross functional team members
ClinPhone Inc., Northbrook, IL
09/03-09/04
Clinical Project Manager
Project Manager for leading IVRS Services Provider to the Pharmaceutical Industr
y; responsible for the direct management of a minimum of five (5) studies concur
rently
Developed Project Specification and coordinate timelines for IVRS Platform desig
n for pharmaceutical and biotech companies
Designed user friendly IVRS Programs (randomization, medication assignment and d
iary)
Coordinated client and internal validation (creation of validation plan, testing
and reports for IVRS)
Investigator Meeting presentations
Oversaw and review data set releases for clients
Managed studies with complex randomization schedules (multiple stratum), med man
agement, diary calls, diary data collection
Responsible for knowledge and adherence to 21 CFR PART 11
TAP Pharmaceutical Products Inc., Lake Forest, IL
04/03-09/03; short term contract
Clinical Research Associate (CRA)
CRA for large-scale Phase III trial within the GI Team at TAP Pharmaceutical Pro
ducts, Inc.
Worked closely with Clinical Study Manger to manage pre-study processes, study i
mplementation and closeout
Protocol development
Informed Consent Form development
Managed site selection process and oversight of forty (40) sites
Negotiated site budgets/Investigator Grants per TAP Corporate Compliance Guideli
nes
Interacted and guided study monitors and individual sites regarding experience,
capabilities, protocol adherence and required site infrastructures
Strategize recruitment program for selected sites
e-CRF scoping and approval
Source Document Creation
Investigator Meeting organization
Managed study under guidance of Clinical Study
Manager
Liaison between Sponsor Safety Team and CRO Safety; assisted in the development
of the Safety Plan
Successfully completed five (5) day Clinical Monitoring and R &D Orientation Tra
ining
AmericasDoctor, Inc., Gurnee, IL
04/01-04/03
Project Manager
Lead Project Manager for Therapeutic Areas of Urology and Womens Health
Managed small and large scale, Phase II-IV trials: site selection, budget discus
sions, site capabilities per protocol (Device studies as needed)
Tracked Project Updates, Study Surveys, Enrollment Performance Index and revenue
projections for upper management
Revised Informed Consent Documents per AmericasDoctor, Inc Guidelines/SOPs clien
t/IRB approval required
Oversaw/managed regulatory document completion, collection and submission throug
hout trial
Communicated with IRBs regarding study review and approval
Lead Project Manager for herbal supplement and nutricuetical projects (Non-IND r
esearch projects)
Informed/educated clients regarding protocol (revisions to existing document), e
lements of Informed Consent (document generation/review), GCP/ICH responsibiliti
es
Lead Project Manager for AmericasDoctor, Inc Guideline Committee: generated, rev
iewed and critiqued new and existing Standard Operating Procedures and Guideline
s
Mentored new members to the Womens Health Network
Northwestern University, Chicago, IL
Department of Preventive Medicine
08/99-04/01
Study Coordinator/Research Technician
CRF entry for ongoing, longitudinal Cardiovascular Study (CARDIA) for young adul
ts within the Department of Preventive Medicine
Responsible for query resolution and Informed Consent process
Coordinated the CARDIA ancillary study, sub-study within the Department of Preve
ntive Medicine
Responsible for team and subject adherence to protocol, CRF entry, determined su
bject eligibility, informed consent process, staff oversight, data collection an
d lab processing
Managed lab, lab staff, supply orders and weekly shipments to lab for processing
(incoming and outgoing)
Processed and stored lab samples
Generated weekly status reports to the MacArthur Foundation regarding enrollment
metrics and data updates via conference calls
Communicated and worked with Local IRB Coordinators regarding submission, review
and revisions to study protocol (on behalf of the MacArthur Foundation) and adv
ertising materials
Lead Research Technician for epidemiological, community research grant within th
e Department of Psychiatry; conducted site [multiple] interviews (data collectio
n) with parents and children participating in HeadStart Sites throughout Chicago
area and CRF entry of collected data
Recruited parents and children for participation in a healthy eating and exercis
e program
Managed the following clinical data points: anthropometric variables (height, we
ight), data collection and CRF scanning, query resolution, subject recruitment,
and tracking and data entry (CRF entry)
Managed Patient Retention Program (i.e., weekly and monthly correspondences rega
rding adherence to program parameters)
EDUCATION
The University of Illinois at Chicago
Bachelor of Liberal Arts, 08/94-05/98
AFFILIATIONS
EMPIRE WHOS WHO; member since 2005
DIA Panel Member, Boston 2008 Annual Meeting
Volunteer: Homeless Cat Network