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clinical project manager

Location:
Fishers, Indiana, United States
Posted:
October 14, 2016

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Resume:

Mary Lou Shepperd

**** * ** *

Lebanon, IN *****

Cell:765-***-****

E-mail: acw169@r.postjobfree.com

EDUCATION

****-**** ******** ***** ********** Stillwater, OK

B.S., Animal Science, minor: Biotechnology

Experience

SPECTRAFORCE TO ELI LILLY 4/14-1/16

Clinical Project Manager

-Provide trial leadership and ownership for a particular trial, set of trials, or programs

-Define the timelines for deliverables and ensure they are delivered to scope, cost, and time objectives

-Budget review and approval

-Coordinate teams across different companies and functional units from around the globe

-Enforce contracts that have been signed previously with a company that was bought by Eli Lilly

-Prepare for FDA and other global agency inspections in keeping with the inspection readiness protocols

-Define Lilly business requirements for the study/program for vendors to deliver

-Project monitoring and quality oversight of sourcing providers

-Review and sign off on invoices from vendors

-Approve or rejecy deliverables

-Work with partners to increase vendor/partner efficiencies

-Negotiation with vendors to gain desired deliverables

-Grant access / Remove access to a Sharepoint Site as an “Administrator”

-Train new project managers that had less in-depth knowledge of clinical trials

-Review of clinical data

-Plan close-outs and start-up of studies and sites

-CRF generation and approval by necessary team members

-Communication with upper management the status of studies and major issues with vendors

INDEPENDENT CONTRACTOR 10/12-4/14

Drug label Editor

-Edit foreign veterinary drug labels for the American market

-Translation of some words from Italian to American English

-Suggest key phrasing used in the American Veterinary market

-Inform the company of US regulations

Note Writer

-Write notes for bestselling books

-Concisely condense a 200 page book down to about 20 pages

GTX – MEMPHIS, TN 03/12 – 10/12

Clinical Safety Manager

-Manage safety vendors

-Interview perspective employees

-Review of vender contracts regarding safety

-Communicate safety needs across departments

-Manage safety for Phases II, III, and IV

-MedDRA coding of terms and WHO coding of drugs

-Interview potential employees

-Train new employees and CROs

-Develop processes

-QC of cases

-AE & SAE sections of DSURs

-PSUR event listings

-Manage protocol deviations worldwide

-Review monitor reports for potential unreported SAEs and Protocol Deviations

-Management and use of ARISg

-Management of all Safety cases

-Review and write informed consent forms (ICFs)

-Write and review protocols

-GCP practices

-Manage the drug safety hotline throughout the day

-Providing documentation for FDA audits

-Participate in FDA audits

-Vendor management

-Data management review and remote monitoring in Target Health and Harrison EDC environments

COVANCE – NASHVILLE, TN 07/05 – 03/12

Clinical Safety Associate

-Manage Drug Safety projects

-Provide updated CVs and signatures for the trial master files

-Answer the drug safety hotline throughout the day.

-MedDRA coding of terms and WHO coding of drugs

-Manage the receipt and processing of all serious adverse event reports reported either spontaneously from any source or from a clinical trial.

-Participate in Covance project teams and client meetings

-Trial master files

-Volunteered in Grants Payments

-Ensure compliant safety reporting in accordance with US and international reporting regulations, Standard Operating Procedures (SOPs) and safety processing guidelines set forth by departmental management team and the client

-Use of SharePoint

-Proficient in several versions of Argus databases

-Use of client’s proprietary safety databases

Clinical Data Coordinator I

-Review clinical trial data utilizing 3 versions of Oracle Clinical

-Multiple studies reviewed at one time

-Reconcile Safety, Lab, and Clinical databases

-Review of data in Electronic Data Capture (EDC) (MediData and Rave)

-Apply Protocol, GCP, and SOP guidelines to data

-Trained on RECIST

-Participate in Covance project teams and client meetings

-Trial master files

-Volunteered in Grants Payments

-Experience in Oncology, Osteoporosis, and IPF

-International study experience

-Train new employees in the use of Oracle Clinical and Data Review, quality assurance of new trainees

-Identify erroneous, missing, incomplete, and/or implausible data

-Generate, resolve, and track queries to address problematic data identified during data review activities

-Call and e-mail clients

-Call clinical sites and monitors

-Data entry for many different protocols

-Occasionally file 1572s, Signature pages, Site CVs, Notes to File, Financial Disclosure Forms, etc.

-Occasionally proof read monitor trip reports

NOVAMED AT ELI LILLY, INDIANAPOLIS, IN 02/05-05/05

Quality Supervisor (this company no longer at this site)

–Resolve quality issues between Novamed and Eli Lilly

–Call customers concerning issues with their pipette calibrations

–Make sure all environmental monitoring devices had preventative maintenance performed on time

–Yearly review of the quality manual and standard operating procedures manual

–Write change controls and deviations

–Cold calling potential customers

ENDOCYTE, WEST LAFAYETTE, IN 10/02-10/04

Animal Biologist

–Manage animal studies in rheumatoid arthritis and oncology.

–Train college students and new employees in lab and animal protocols

–Dose mice IV, Sub-C, and / or IM

–Report and graph data.

–Write FDA clinical trial reports for ELISAs I had run on human patients.

–Process and report Phase 1 clinical samples

–Write SOPs.

–GCP, GMP & GLP training.

–Radioactivity training and studies using radioactivity.

KELLY SCIENTIFIC TO ELI LILLY, INDIANAPOLIS, IN 2/01-7/02

Animal Biologist

–Obesity research utilizing rodents and canines

–Rodent research skills: Dosing sub-C, IM, IV, oral gavage, food intake monitoring, blood collection, 3rd ventricle canula surgery and dosing, oxymax chambers, euthanasia

–Canine research skills: dosing sub-C, IM, and IV catheterization. Vital signs, restraints, and oxymax chambers.

–Lilly training in: radiation, SOA, rodent and canine husbandry, legal, notebook.

–Prep assigned areas for AAALAC and USDA inspection.

–Run Heska blood and Beckman glucose analyzers.

–DEXA of rodents and canines.

–Use of Excel, Sigma plot, Sigma Stat, Word, and Power Point to present data.

SKILLS

–Microsoft Word

–Microsoft Excel

–Microsoft PowerPoint

–Microsoft SharePoint

–Microsoft Project

–Lync

–Safety Databases: ARGUS, ARISg, and proprietary client databases

–Several versions of ORACLE databases for data management

–EDC databases: Rave, MediData, Target Health and Harrison’s EDC databases



Contact this candidate