1. MARIA BLOODGOOD
202 Turnbridge Court
Avondale, PA 19311
Residence: (610) 268-2860
Mobile: (484) 995-1736
Email: mariabloodgood1965@verizon.net
SUMMARY:
Innovative project & process management professional in the pharmaceutical industry focusing on
Clinical Development, Medical Affairs Laboratory areas for 20+ years. Therapeutic areas of focus
include Gastrointestinal, Cardiovascular, Respiratory, Oncology, Central Nervous System and Pain
& Infection. Recognized for strong interpersonal skills, strategic planning, clinical project
management methodologies, clinical operations, the drug development process and GCP & ICH
guidelines. Proficient at leading global cross-functional teams, regulatory documentation, drug
forecasting, publications, budget management, study milestones and metrics reporting. Proven
contribution to strategy development, feasibility assessment and mitigation activities. Proficient
performance through communication, collaboration, confident assertiveness, positive team-
facilitation and management. Recognized for mentoring peers and junior staff members.
PROFESSIONAL EXPERIENCE:
EUROFINS CENTRAL LABORATORY December, 2014/Present
Project Management – Global Project Manager
Accountable for providing superior sponsor-experience and project performance whilst exceeding
the client’s expectations and specifications. Responsible for superior level of service surrounding
time, quality and budget management of awarded projects. Managing and driving successful
project management surrounding harmonization of all internal and external activities to ensure
smooth, timely and accurate flow of information. Sustain and strengthen client relationships and
support business growth through repeat business.
Key Accountabilities
 At as first point of contact for all assigned studies and sponsors.
 Liaise with internal and external customers to ensure smooth management of study
assignments.
 Consult and provide operational input into quotes / proposal to ensure capabilities and client
needs are aligned.
 Check scope of work and budget accurately reflect protocol and documented client
expectations at all times. Initiate change request/amend project (specs, budget, contract)
with client, proposal team and sales rep for any deviations, keeping all documentations
consistent throughout.
 Define project milestones and check project performance against plan, from signed contract
(budget approved) to invoice paid.
 Ensure the project is conducted in accordance with set global standards and procedures.

2.  Management of budget for assigned studies. External: track budget to burn, and revenue
recognition/invoicing. Internal: make accurate activity and revenues forecasts
 Maintain accurate study files as required for prevailing regulatory inspections (during or
after the study) and support successful client and internal audits.
 Monitor project performance against contract (specifications, time and spend) and
initiate/follow through relevant remedial actions and changes in specifications as related to
the budget and contract.
 Proactively drive to completion all outstanding lab analysis for assigned studies as per
agreed timelines.
 Act as backup PM for colleagues on other global projects during their absence.
PENTICO SOLUTIONS, Berwyn, PA March, 2013/May, 2014
Medical Affairs, Janssen Biotech – Project Manager
Responsible for managing full scope global projects for special identified reports and protocol
development. Accountable for cross-function project team leadership including the facilitation,
agenda and minutes for internal and client team meetings. Responsible for developing and driving
timelines and resource management in accordance with the project Scope. Milestone planning,
monitoring, risk planning, identifying risks and recommending corrective solutions, managing
dependences, managing change, identifying deliverables, risk planning and communication
management through the life of the project. Responsible for building and maintaining positive client
relationships. Maintain current knowledge of company and client SOPs, country regulations, GCP
and ICH guidelines. Positive feedback from management received and contract extended for
additional assignments.
ASTRAZENECA, Wilmington, DE August 1994/July 2011
Clincal Development (2005/2011) / Associate Clinical Project Manager
Phase IV, Post Marketing, Investigator-Sponsored Studies (ISS)
Responsible for the successful and robust program delivery of clinical investigations from study
concept to closeout. Liaison for internal and external key stakeholders. Individual ISS study budget
management and ISS therapeutic area management, risk management and governance activities
while monitoring clinical study protocols, regulatory documentation, study agreements, clinical
drug supply, pure powder requests, recruitment, adverse event reporting, status update reports,
milestones, publications and study closure requirements.
 Therapeutic Areas (TA) managed:
o US & Global Oncology Program – 40+ Studies/250+ Patients (2009-2011)
 Successfully drove 15+ laggard studies to closure within 6 months of TA
assignment
 Reduced overall TA budget by 750K within 6 months.

3. o US & Global Gastrointestinal Program – 120+ Studies/2000+ Patients (2008-2011)
 Upon assignment of TA successfully drove 40+ studies to closure and reduced
budget by over 250K.
o US Cardiovascular Program – 70+ Studies/1000+ Patients (2008-2010)
 Successfully drove 20+ studies to closure upon assigned TA of laggard studies.
 Reduced overall TA budget by 200K within 3 months.
o US Central Nervous System Program – 120+ Studies/1200+ Patients (2005-2007)
 Successfully drove 25+ studies to closure within first year with budget reduction
of over 500K.
 Led cross-functional study teams from strategy through execution within a matrix environment
 Collaborated with Therapeutic Brand Leader on program strategy, feasibility assessment and
protocol development
 Drove the process to ensure study milestones and program deliverables were met within Brand
Team timelines
 Provided quarterly status updates to the US Brand Team and global counterparts as appropriate
 Monitored and tracked clinical study protocols, regulatory documentation, drug supply,
enrollment, study payments, SAEs and study closure documentation.
 Forecasted and process requests for clinical drug supply with IPS or Commercial Operations
 Managed external service providers and liaison for Investigators, Associated Staff and Regional
Scientific Managers
Medical Affairs
Senior Inquiry Management Associate 2001/2005
Liaison between Medical Research (MR), Information Center, Regulatory Affairs, Field Sales,
Medical Affairs , and Records Management departments, providing support for the Central Nervous
System, Pain and Infection and Respiratory therapeutic areas. Also, as Inquiry Management
Project Lead, led partnership between software development vendor and Information Services Team
to design and create training documents for internal end users on new application to support
Professional Information Resources (PIR) daily activities. Subsequent system release resulted in
50% improvement in productivity. Also, Team Lead on Operational Optimization effort to
streamline process workflow. Identified needs, developed plan, influenced stakeholders, managed
budget and communicated team progress to stakeholders.
Major Responsibilities: Address and track to completion, requests by Medical Research (MR) to
augment PIR system capabilities, calculate and report specified metrics and provide trend analysis
related to inquiries. Also, develop Standard Operating Procedures (SOP’s) and training programs
for internal and external customers.

4. Inquiry Management Associate 1999/2001
Lead on Y2K project, partnered with Information Systems, Records Management and Site Services
to develop a Medical Research Contingency Plan. Also, Liaison supporting the merging of the
Astra and Zeneca legacy organizations providing support for a change management effort designed
to harmonize and implement effective process integration. Provided metrics, developed training
program and trained IM team on new business systems and processes resulting in successful team
system and process integration.
Document Administrator 1994/1999
Departmental Point Person charged to provide support for necessary post Astra Merck and Astra
merger activities. Provided support for the change management process integration effort.
Specifically, developed a training program and trained IM team on new processes and represented
IM on a field sales training program. Also, partnered with vendors, internal and external customers,
to develop and implement a field sales training program that educated the field on MR services.
Facilitated 12 sales force training sessions delivering MR knowledge. Utilized survey results to
assess program success and reported metrics to leadership.
EDUCATION:
Bachelor of Arts, Organizational Dynamics
Immaculata University, Immaculata, PA
Gastrointestinal Preceptorship
Medical College of Wisconsin, Milwaukee, WI
(Program focused on diagnostic technologies (CAT scan, pH monitoring, endoscopy, etc.) used in
treating Gastroesophegeal Reflux Disease, ulcers and other gastric conditions/diseases).