Peter Michas

** ********** ***.

Marlton, NJ ****3

609-***-****

ac74d2@r.postjobfree.com

Professional Experiences:

Axelon Services Corporation, Performing Services on behalf of Johnson & Johnson R&D Procurement Janssen Research and Development, LLC

Compliance Specialist Oct. 2017 to Present

●Totality and PRIZMA Management:

1.Manage Totality Flex Coordinators (2)

2.Ensure “new Supplier add” in ARAVO is supported

3.Ensure the initiation and completion and lifecycle management of HCC/Totality/PRIZMA (mid 2018) requests and approvals are tracked and accurate

4.Act as SME, liaise or facilitate responses to inquiries from internal and external stakeholders

5.Liaise with key HCC professionals as appropriate

6.Educate/update business partners and supporting staff on contracting compliance

7.Comply with request from QA and auditors

●Maintain CAPA Tracker:

1.Maintain and manage Internal JRP CAPA Tracker

●Approved Supplier List for Client:

2.Facilitate Client ASL Process for Suppliers in ADAPTIV System

3.Liaise with Enterprise model

●Oversight to TPI Due Diligence with KPMG:

1.Oversight to ensure resolution of TPI DD/KMPG escalations

2.Support TPI DD questions for KMPG

●AdHoc projects

1.Follows standard Procurement policies and procedures, Health Care Compliance Policies, for multiple therapeutic areas in various geographic areas

MedAvante, Inc., Hamilton, NJ

Associate Data Manager Feb. 2017 to Jun. 2017

●Manage all aspects of data transfers to sponsors/CROs:

1.Draft/Finalize Data Transfer Plans

2.Create and test data extract files

3.Create and provide sample/test data transfers to sponsors/CROs

4.Perform data extract for periodic/routine data transfers

5.Assist in resolving sponsor/CRO data queries

●Manage Enterprise data (Sponsors, Investigators, Raters and Scales, etc.)

1.Develop Data Conventions for entering, maintaining, cleaning enterprise data

2.Train system users in data conventions

●Manage Item Score repository:

1.Work with Clinical Development to understand ways in which data will be analyzed

2.Work with Operations to clean/complete data

3.Work with IT development team to check/verify continuous integration of enterprise and item score information from source databases

●Implement solutions for handling process changes – through existing or new system features.

●Develop (and/or write requirements for) data management reports/ queries to enable/facilitate data monitoring across all operational systems.

●Run and review results of periodic/routine data checks.

●Resolve/escalate production data issues by researching and identifying the root cause of the issue and working with appropriate resources to fix the issue.

●Work with data owners (and QA) to document circumstances surrounding data discrepancies and solutions to address errors.

●Detect and identify enhancements and improvements that increase the quality and efficiency of data processing.

Covance, Clinical Development Services, Princeton, NJ, USA - Feb. 2013 –Feb. 2017

Associate, Global Site Services Mar. 2016-Feb. 2017

●Collect, review, process, and track regulatory and investigator documents for study site activation in accordance with SOP's, ICH GCP, EU clinical Trial Directive, FDA Regulations, and Investigator Package Plan.

●Assist in review and approval of regulatory and investigator documents for study site activation.

●Assist in preparation for project specific plans.

●Assist in review of core English, Country, and site specific core patient informed consent.

●Maintenance of study personnel

●Maintenance of study amendments.

●Liaise with applicable IRB/IEC regarding investigator submission/approval issues.

Clinical Project Administrator Feb. 2013 -Mar. 2016

●Provide clerical support to project team (e.g., document tracking, word processing, proofreading and editing correspondence, large and small documents, mailings, shipment of study files, fax and photocopy documents, assemble study documents, and arrange meetings, etc.)

●Provide clinical protocol TMF and eTMF protocol compliance

●Provide telephone coverage and related support duties

●Set up and maintain clinical investigator files and documentation

●Prepare investigator budget payments and tracking systems; generate tracking reports as assigned

●Data entry and maintenance of selected study tracking databases

●Prepare monitoring visit documentation for Clinical Research Assistants and above, as requested by supervisor

●Prepare study-related documents and other materials for delivery to archives, at appropriate intervals

●Perform other administrative duties as assigned by management

BioClinica Inc. Newtown, PA Feb. 2000-Oct. 2012

CRO providing clinical trial design and management for pharmaceutical, biotechnology, and medical device companies including Merck, J&J, Novartis, Abbott, Amgen, Eli Lilly, Pfizer & GSK; chiefly focused on Phase II & Ill clinical trials

Data Associate, Clinical Imaging Sep. 2003-Oct. 2012

●Data management activities from study start-up to database lock

●Query data management listings

●Data cleaning

●Receive and import clinical trials imaging data from via web, CD/DVD or diskette sources

●Quality assurance check by verifying patient study date & data transmittal form to ensure compliance with client study protocol

●Quality assurance check by verifying subject, time point, scan date, modality and number of images

●Receive and process client data requests from Project Managers

●Attend internal client kick-off meetings for new and ongoing clinical studies

●Provide input on study timelines, data compatibility

●Confirm status and data capability to Project Manager for reporting back to client

●Provide feedback on status of ongoing clinical studies, time lines or issues

●Conversion of data to DICOM format and uploading into PACS system

●Upload other file formats into network according to protocol

●Query clinical data accirding to study protocol and SOP

●UAT Testing BioPACS, BioTrack

Administrative Associate Feb. 2000-Sep. 2003

●Management of the medical imaging and documentation for onsite and offsite storage through the use of the internal tracking system (Bio-Track)

●Shipment of medical imaging data & supplies to client

Virtua Hospital Marlton, NJ Sep.2001-Dec.2004

Medical Records Clerk (Weekends)

●As sole person in department on weekends; internally tracked, pulled, copied, filed, and assembled medical charts according to Hospital guidelines and SOP's

Education:

DeVry University, Addison, IL

Bachelor of Science in Technical Management Feb.2012

Relevant Course Work:

Data Applications and Health Care Quality, Pharmacology and Medical Treatment, Fundamentals of Pathophysiology, Health Information Processes, Introduction to Health

Technical Experience:

Windows XP, Windows 7, Power Point, MS Excel, Diamond II (CTMS, eTMF, PWF) EDC Bio-PACS, Digital Jacket, Array, Osiris, E-film, and Tomovision

Workshops and Seminars:

Good Clinical Practice (GCP), Regulatory Procedures, Medical Billing and Coding Practices and Procedures, Medical Terminology

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