This document provides a summary of Maria Bloodgood's professional experience and qualifications. She has over 20 years of experience in project management roles in the pharmaceutical industry, focusing on clinical development and medical affairs. Her most recent role is as a Global Project Manager at Eurofins Central Laboratory, where she is responsible for managing projects and ensuring they are completed on time, on budget, and meeting quality standards. She has extensive experience managing clinical studies and programs across multiple therapeutic areas.
I am writing in regards to the Clinical Research Associate position that is open with your company at this time. I am an experienced CRA with over three years in clinical trials with broad background in clinical trials management of Phase II/III trials in various indications including the implementation of study protocols, monitoring of study sites and on-site data management and collection of study-related documents. With excellent organizational skills and a profound background of working in a managerial capacity, along with my ability to learn rapidly and proficiently, will allow me to be a valuable part of your team as well as contribute to your constant success.
After reviewing the FDA regulations on Risk Based Monitoring, review the details on how to put the principles into action! We include two reference documents to help you get started... and to make it a success.
How engaged are the stakeholders in your clinical data management projects?
As you know that the engagement level of stakeholders play an important role for the success of the clinical trial. The attached article explains the importance and processes of managing stakeholders’ engagement in clinical data management. We hope that you find this useful. Connect with us to hear more from our experts in this area.
Risk-based Monitoring Strategies for Improved Clinical Trial PerformanceCognizant
To address draft regulatory guidance for risk-based clinical trial monitoring, sponsors should consider strategies that utilize social, mobile, analytics and cloud technologies to create responsive methodologies that satisfy both the spirit and the letter of these new guidelines.
The Integrated Early Drug Development Platform White PaperCovance
Is it possible to deal with the explosion of complexity in the early clinical development space? Is the traditional clinical pharmacology unit obsolete? The answers are yes and no, respectively. The optimal engine for early clinical development in the modern era is an integrated early drug development platform.
ExL Pharma Clinical Trials Phase I and Phase IIa Conference Brochure: Phase 1...bryonmain
There is a pill or treatment for almost everything, or at least, that is how it seems. However, the amount of effort that goes into a pill or treatment before it is launched is extensive, expensive and often inefficient.
Efficiency and innovation go hand-in-hand with R&D and the development of clinical trials, however, FDA regulations and clinical trial standardization end up stifling these two key factors. This leads to drawn out processes that cost companies hundreds of millions of dollars before the drugs hit the market. Efforts have been made to increase efficiency in phase I/IIA with some companies changing their clinical trial manifestos to suit the available patient population at clinical sites, but more emphasis should be placed on creating more efficient processes for first in human studies by optimizing pharmacokinetics/pharmacodynamics, dosage selection, technological advancements to improve efficacy and structured patient mapping to increase successful trial and patient recruitment opportunities.
This program will give delegates the opportunity to share proven strategies between companies to help increase efficiency in this space and streamline processes to cut down costs. This event will bring together large and small companies and experts in this space to share best practices to decrease the financial drain theses phases have on the overall clinical trial budget. Life science corporations need the most up-to-date tools and practices to increase success by streamlining processes, sharing successful biomarker strategies, anticipating dosing quantities, and optimizing healthy or specialty patient recruitment and retention. Current strategies include patient mapping before organizing and setting up a clinical space, tailoring early phase clinical trials to patient populations, purchasing biological samples from collection companies, and trying to accelerate the process by submitting for breakthrough therapy designation.
Top Reasons To Attend
Identify Compound Development Strategies to Optimize Success in Clinical Trials
Learn Best Practices for Early Decision-Making Through Analysis of Biomarker Utility in Drug Development
Utilize Analytical Technology to Evaluate Multiple Configurations of a Small Molecule to Increase the Feasibility of Drug in Clinical Trials
Implement Adaptive Design in Proof of Concept Studies to Increase Efficiency, Decrease Time and Decrease Overall Cost
Explore the Seamless Development of Phase I to Phase II in Clinical Trials
NINE Case Studies and a Panel Session on Early Phase Clinical Trial Strategies
Developing and maintaining strong relationships between the Sponsor and the selected CRO can make or break a clinical study. In this webinar, two experts with experience managing clinical programs from both a CRO and a Sponsor perspective provide tips and strategies for optimizing these relationships using real world examples.
I am writing in regards to the Clinical Research Associate position that is open with your company at this time. I am an experienced CRA with over three years in clinical trials with broad background in clinical trials management of Phase II/III trials in various indications including the implementation of study protocols, monitoring of study sites and on-site data management and collection of study-related documents. With excellent organizational skills and a profound background of working in a managerial capacity, along with my ability to learn rapidly and proficiently, will allow me to be a valuable part of your team as well as contribute to your constant success.
After reviewing the FDA regulations on Risk Based Monitoring, review the details on how to put the principles into action! We include two reference documents to help you get started... and to make it a success.
How engaged are the stakeholders in your clinical data management projects?
As you know that the engagement level of stakeholders play an important role for the success of the clinical trial. The attached article explains the importance and processes of managing stakeholders’ engagement in clinical data management. We hope that you find this useful. Connect with us to hear more from our experts in this area.
Risk-based Monitoring Strategies for Improved Clinical Trial PerformanceCognizant
To address draft regulatory guidance for risk-based clinical trial monitoring, sponsors should consider strategies that utilize social, mobile, analytics and cloud technologies to create responsive methodologies that satisfy both the spirit and the letter of these new guidelines.
The Integrated Early Drug Development Platform White PaperCovance
Is it possible to deal with the explosion of complexity in the early clinical development space? Is the traditional clinical pharmacology unit obsolete? The answers are yes and no, respectively. The optimal engine for early clinical development in the modern era is an integrated early drug development platform.
ExL Pharma Clinical Trials Phase I and Phase IIa Conference Brochure: Phase 1...bryonmain
There is a pill or treatment for almost everything, or at least, that is how it seems. However, the amount of effort that goes into a pill or treatment before it is launched is extensive, expensive and often inefficient.
Efficiency and innovation go hand-in-hand with R&D and the development of clinical trials, however, FDA regulations and clinical trial standardization end up stifling these two key factors. This leads to drawn out processes that cost companies hundreds of millions of dollars before the drugs hit the market. Efforts have been made to increase efficiency in phase I/IIA with some companies changing their clinical trial manifestos to suit the available patient population at clinical sites, but more emphasis should be placed on creating more efficient processes for first in human studies by optimizing pharmacokinetics/pharmacodynamics, dosage selection, technological advancements to improve efficacy and structured patient mapping to increase successful trial and patient recruitment opportunities.
This program will give delegates the opportunity to share proven strategies between companies to help increase efficiency in this space and streamline processes to cut down costs. This event will bring together large and small companies and experts in this space to share best practices to decrease the financial drain theses phases have on the overall clinical trial budget. Life science corporations need the most up-to-date tools and practices to increase success by streamlining processes, sharing successful biomarker strategies, anticipating dosing quantities, and optimizing healthy or specialty patient recruitment and retention. Current strategies include patient mapping before organizing and setting up a clinical space, tailoring early phase clinical trials to patient populations, purchasing biological samples from collection companies, and trying to accelerate the process by submitting for breakthrough therapy designation.
Top Reasons To Attend
Identify Compound Development Strategies to Optimize Success in Clinical Trials
Learn Best Practices for Early Decision-Making Through Analysis of Biomarker Utility in Drug Development
Utilize Analytical Technology to Evaluate Multiple Configurations of a Small Molecule to Increase the Feasibility of Drug in Clinical Trials
Implement Adaptive Design in Proof of Concept Studies to Increase Efficiency, Decrease Time and Decrease Overall Cost
Explore the Seamless Development of Phase I to Phase II in Clinical Trials
NINE Case Studies and a Panel Session on Early Phase Clinical Trial Strategies
Developing and maintaining strong relationships between the Sponsor and the selected CRO can make or break a clinical study. In this webinar, two experts with experience managing clinical programs from both a CRO and a Sponsor perspective provide tips and strategies for optimizing these relationships using real world examples.
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Tutorial Membuat Banner (small banner linked to blog), pertama kali dipresentasikan pada event Ngobrol Cantik ala Blogger Perempuan di Bogor 9 Juli 2015.
Banner dalam konteks ini ialah gambar kecil yang mewakili blog kita (bisa berupa logo atau lainnya) yang mengandung link URL blog Jika banner ini dipasang di blog lain akan berfungsi sebagai backlink. Backlink merupakan salah satu faktor penentu Domain Authority (DA). Jika banner blog kita terpasang di banyak blog/website lain, DA blog kita akan semakin baik.
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LOOKING BACK TO LOOK FORWARD
The Marc Jacobs brand is the brainchild of renowned designer and the brand’s namesake, Marc Jacobs. The Marc Jacobs brand creates beautiful, high-fashion shoes and clothing.
Customisation in the future of retail is going to be built around experience. Collaboration, experimentation, individuality and comfort all provide the consumer with a new innovative way to interact with the product. In the future companies will need to assist their consumers in the design of the product. The resurgence of an independent consumer will bully the market into having to appreciate the fact that, the consumer always knows best and force selling will cease to exists.
Key steps, rules and laws for achieving personal happiness and staying happy. Every slide presents a specific step, rule or law. These steps, rules and laws are universally applicable regardless of nationality, race, religion, income, etc.
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).