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AHRM Inc - Director, Clinical Services & Project Management Resume Example

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DIRECTOR, CLINICAL SERVICES & PROJECT MANAGEMENT
Licenses

Certified Clinical Research Professional (CCRP)

Skill Highlights
  • Strong background in FDA drug safety guidelines

  • Experience in Phase I - IV clinical trials
  • Project Management

  • Experience in HEOR
Professional Experience
Director, Clinical Services & Project Management
March 2008 to Current AHRM Inc － Buffalo, NY , Raleigh, NC
  • Provide/Oversee Project Management for Phase I-IV Clinical Trials and HEOR Studies
  • Attend conferences, symposiums and workshops relevant to specific therapeutic areas
  • Implement and oversee clinical trial protocols at study affiliated sites
  • Request, collect, organize and complete all necessary documents for IRB submission
  • Establish/implement guidelines for the collection of clinical data and/or administration of clinical trials
  • Develop Informed Consent/Assent Forms, (e)CRFs/CRFs, SOPs, Site Qualification Surveys, Data Management Manuals, Site Manuals, Data Dictionaries and Monitoring Plans
  • Develop and maintain PI and site databases
  • Write/review/approve publications Develop and Implement Patient Reported Outcomes Forms and Questionnaires
  • Coordinate the ongoing analysis and modification of protocols as appropriate
  • Perform site qualification, site initiation, and interim monitoring visits
  • Coordinate/establish clinical trials schedules, task assignments, and allocation of resources to ensure conformance with specified objectives
  • Prepare reports reflecting progress and/or adverse trends and make appropriate recommendations
  • Perform/oversee MedDRA and WHO-DD coding
  • Write/review edit checks and logical checks and create associated reports
  • Create ad hoc reports to identify and resolve potential data issues
  • Assist with the development and implementation of operating policies and procedures and ensure compliance with established practices
  • Oversee the identification and reconciliation of SAEs
  • Manage CRAs, Data Managers and Project Managers
  • Responsible for hiring and training of new staff
  • Held previous positions as CRA and Senior Project Manager with this company
Coordinating Data Manager
October 2003 to March 2008 Frontier Science and Technology Resource Foundation － Amherst, US, New York
  • Coordinated all data management aspects of an international clinical breast cancer trial involving 8,000 subjects and five sub-studies
  • Supervised nine data managers, including the SAE reconciliation team
  • Met all deadlines associated with database freezes and locks
  • Supervised data flow and implemented changes when necessary
  • Assessed the minimal daily data volume required to meet upcoming deadlines
  • Communicated with vendors to identify specific SOP requirements for data transfer files, including file format and transfer request submissions
  • Arranged and conducted weekly meetings with internal/external study team members
  • Developed/reviewed protocols, handbooks, manuals, monitoring plans, informed consent documents, CRFs, and SOPs
  • Prepared reports during database freeze to identify outstanding critical queries requiring resolution
  • Coordinated the maintenance/operation of relational databases, query reports and forms requests, data transfers, database freeze and database lock procedures
  • Resolved conflicts both trial wide and center specific, as well as issues with vendors
  • Delivered presentations at international annual meetings (St.
  • Gallen, Switzerland and Nice, France)
  • Collaborated with the Biostatistics Department to write/implement data checks and resolve data discrepancies
  • Co-chair, Team Building Committee and Chair, Staff Development Team.
  • Held previous positions as Protocol Data Manager and Lead Data Manager with this company
Intake Coordinator
June 2001 to August 2003 Cradle Beach Camp － Angola, New York
  • Specialized residential summer camp integrating children with disabilities and those who are economically disadvantaged.
  • Recruitment, assessed and determined eligibility of potential campers
  • Processed camper applications and assessed appropriate placement
  • Maintained camper database which included over 2000 records.
  • Prepared statistical, demographic and financial reports for private and government funding sources
  • Coordinated services based on individual camper needs and collaborated with other service providers to determine the appropriate camper/staff ration
  • Developed/delivered presentations to promote the awareness and programs of Cradle Beach Camp.
Research Assistant
March 2000 to June 2001 Neighborhood Legal Services, Inc － Buffalo, New York
  • Temporary grant position working with individuals with a primary mental health diagnosis
  • Coordinated services for participants in a pilot project to assess the barriers in obtaining and maintaining employment
  • Collaborated with Social Security Administration and NYS Dept.
  • of Labor project personnel
  • Scheduled and conducted individual and group meetings for eligible participants, and obtained informed consent
  • Arranged and conducted weekly meetings with internal/external study team members
  • Entered and maintained participant data in an SPSS relational database
  • Obtained certification as a Benefits Advisor, which provided me with the knowledge of how Social Security Disability and Supplemental Security benefits are impacted by employment.
Education and Training
Bachelor of Science : Human Services, 5/1999 Hilbert College － Hamburg, New York, USA
MBA : Business, 12/2015 Louisiana State University － Shreveport, LA, USA

Community Service

Make-A-Wish - Eastern NC Chapter

Habitat for Humanity

Freedom 4 24

Velo for Yellow

Professional Affiliations

National Headache Foundation

Society for Clinical Research Associates Society for Clinical Trials

Women in BIO

Business and Professional Women of Raleigh

National Association of Women MBAs


Publications

Manuscript submitted: CLARITY: Evaluation of the effectiveness and durability of benefit of onabotulinumtoxinA in adults with chronic migraine: a pilot study - The Journal of Headache and Pain Blumenfeld A, Inocelda A, Purdy C, Dalfonso L, Magar R (2015).


Blumenfeld, A. M., Inocelda, A., Purdy, C., Dalfonso, L., & Magar, R. (2015). The durability of onabotulinumtoxinA for the treatment of chronic migraine: CLARITY Pilot Study. Toxicon, 93, S11.


An Inquiry Into Prophylactic Treatment Patterns by Migraine Diagnosis: The AMEND Study- AAN 2015 Reddy A, Policastro A, Reppine A, Sekab J, Purdy C, Dalfonso L, Magar R Reddy A, Policastro A, Reppine A, Sekab J, Purdy C, Dalfonso L, Magar R


Assessing Migraine: An Enquiry into Prophylactic Treatment Patterns by Diagnosis: The AMEND Study - April 6, 2015 84:14 Supplement P3.042; 1526-632X


A. Gupta, H. Lehman, L. Dalfonso, C. Gressani, C. Purdy, L. Wetzel, R. Magar Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research 1 May 2014 (volume 17 issue 3 Page A179 DOI: 10.1016/j.jval.2014.03.1045)


Blumenfeld, A, Inocelda A, Cunanan C, Purdy C, Dalfonso L, Magar R. (2014). Long-term treatment of chronic migraine with onabotulinumtoxinA: CLARITY pilot study. The Journal of Pain, Volume 15, Issue 4


Blumenfeld, A., Inocelda, A., Cunanan,C., Purdy, C., Dalfonso, L., & Magar, R. (2014). The Durability of OnabotulinumtoxinA for the Treatment of Chronic Migraine: CLARITY Pilot Study (P7. 186). Neurology, 82(10 Supplement), P7-186.


The Durability of OnabotulinumtoxinA for the Treatment of Chronic Migraine: CLARITY Pilot Study - DHCREF 2014 Blumenfeld A, Inocelda A, Purdy C, Dalfonso L, Magar R


The Durability of OnabotulinumtoxinA for the Treatment of Chronic Migraine: CLARITY Pilot Study - PAINWeek 2014 Blumenfeld A, Inocelda A, Purdy C, Dalfonso L, Magar R


A Non-Interventional Retrospective Evaluation of Resources Consumed During the Provision of Care for Overactive Bladder Syndrome: A Real World Evaluation: German Perspective (The Reduce Study) M. Indig, C. Purdy, R. Magar, L. Dalfonso, C. Walters, J. Nazir. Value in health: the journal of the International Society for Pharmacoeconomics and Outcomes Research 1 November 2013 (volume 16 issue 7 Page A632 DOI: 10.1016/j.jval.2013.08.1880)


A Non-Interventional Retrospective Evaluation of Resources Consumed During the Provision of Care For Overactive Bladder Syndrome: A Real World Evaluation (The Reduce Study - Interim Analysis) Gärtner M, Petzel M, Kublanck A, Eckert R, Schmidtke M, Purdy C, Magar R, Dalfonso L, Walters C (2013) Yoelin S, Caulkins C, Magar R, Purdy C, Dalfonso L.


Interim Analysis of A Non-Interventional Observational and Medical Records Review of Patient Outcomes with Bimatoprost Ophthalmic Solution 0.03% for the Treatment of Hypotrichosis of the Eyelashes. Presented at World Congress of Dermatology Seoul, Korea, May 2011


A full listing of publications is available upon request SELECT

Skills

ad, Benefits, cancer, Clinical Research, clinical trials, conferences, Data Management, data transfer, databases, database, diagnosis, edit, financial reports, Forms, GCP, government, hiring, Team Building, meetings, mental health, 2000, Nice, Notary Public, personnel, policies, presentations, coding, progress, Project Management, protocols, publications, Recruitment, relational database, relational databases, Research, SOP, SPSS, Staff Development, Surveys, workshops

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Resume Overview

Companies Worked For:

School Attended

  • Hilbert College
  • Louisiana State University

Job Titles Held:

  • Director, Clinical Services & Project Management
  • Coordinating Data Manager
  • Intake Coordinator
  • Research Assistant

Degrees

  • Bachelor of Science : Human Services , 5/1999
    MBA : Business , 12/2015

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