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External Protocol Data Manager

Location:
Levittown, PA, 19056
Posted:
October 02, 2018

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Resume:

Erica Musser Resume

Erica Musser

** **** ****

Levittown, PA 19056

215-***-****

ac685f@r.postjobfree.com

Summary

• As an ePDM, supporting the collection and management of externally sourced data from study maintenance through database lock and submission to ensure efficiency and quality throughout the life of the clinical trial. Prior Research Associate with 12 years of pre-clinical pharmaceutical research experience. Performs well in a detail oriented, fast pace environment. Understands the importance of working individually or in a group setting. Exhibits exceptional organization skills promoting work and project efficiency. Thrives on and values quality work.

EXPERTISE/PROFICIENCIES

• Oracle Clinical

• JReview

• SQL

• Requisearch

• ICOLAB

• TAO

• Standard Operating Procedures (SOP)

• Good Laboratory Practices (GLP)

• Institutional Animal Care and Use Committee (IACUC)

• Microsoft Office

• Trackwise QMS software

• Provantis software

• 6400 Computer Systems

External Protocol Data Manager (ePDM)

DOCS on Assignment with Bristol-Myers Squibb

2018 – Present

• Coordinates all collection and review activities related to external vendor laboratory or modality data. Serves as liaison between BMS and vendor data management teams. Erica Musser Resume

• Provides scientific and technical expertise in developing data and transfer requirements for a wide variety of specimen results.

• Demonstrates a strong understanding of the overall project goals. Develops project plan. Evaluates potential problems and risks. Communicates deliverable strategies and timelines to stakeholders to ensure objectives are met.

• Reviews transferred data for quality and validity. Proactively resolves data, vendor and investigative site issues. Assures complete sample collection and metadata accuracy.

• Effectively uses available tools (e.g. JReview, Study Management Tools, eDM, RAVE, SQL, TOAD, Spotfire) to gather information needed to manage study activities.

• Drives quality through partner vendor workshops, process improvement and best practice initiatives.

• Provides on-going training and mentoring to team members through mentoring process using informal and/or formal presentations.

• High level of competence using computer systems and applications such as Oracle Clinical, RAVE, SAS, SQL, JReview, Spotfire.

• Comprehensive understanding of clinical drug development process, including PK, PD and Laboratory testing terminology. Strong analytical skills to facilitate detecting and resolving data problems.

• Experience in management of multiple simultaneous projects in a matrix environment. Research Associate, Blood Coordinator

Charles River Laboratories, Horsham, PA

2013 – 2018

• As Research Associate, exercise judgment within defined Standard Operating Procedures and practices to determine appropriate action.

• As Blood Coordinator oversee and facilitate highly specialized techniques required during study conduct regarding Blood Collection and Blood Processing. Certified IATA and HazMat shipper playing essential role all In Life Sample Shipments.

• Integral in standardizing generic wording for protocols and display knowledge in protocol and SOP revision.

• Study forecast/Protocol review - Routinely communicate with Study Directors involving protocol wording and study design. Participate in correspondence with study sponsors and study monitors.

• Train blood related procedures/techniques

• Integrate contributor in developing/utilizing Tail Snip, a non-terminal blood collection route of juvenile rodents

Erica Musser Resume

• Investigate/Trial routes of collection not established for upcoming studies

• Review blood collection/Processing data – address deviations

• Create sample manifests, Specimen Packing Lists and International documents needed for shipment. Communicate with sample recipient to obtain confirmation of shipment as well as address any discrepancies/questions/concerns (regarding labels, packing list, data, etc.)

• Discard/Archive samples as per Study Director request

• Maintain inventory and ordering all supplies used for blood collection and processing

• Maintain inventory of ~50 micropipettes used for In Life and Necropsy department. Assign pipettes for use on study.

• Maintain inventory of ~20 centrifuges. Assign to study weekly. Complete non-routine maintenance request if applicable.

Research Technician IV

Charles River Laboratories, Horsham, PA

2010 – 2018

• Served as lead technician for many complex Reproductive Toxicity Preclinical studies. Responsibilities including test article administration, sample collection, generating data, handling/restraining/providing care for animals.

• Ensures raw data records are accurate, complete, and meet protocol specifications, Good Laboratory Practices, and/or Standard Operating Procedures with minimal supervision.

• Obtained Behavior Certifications including Morris Watermaze (Rat and Mouse) and Functional Observational Battery testing in company with numerous routes of test article administration and blood collection in rats, mice, and rabbits. Specialty areas consist of Neonatal test article administration and natural delivery.

• Additional routes of test article administration in multiple species (rats, mice, and rabbits) include gavage, intravenous (bolus and infusion), intraperitoneal, intramuscular, subcutaneous, dermal, and intradermal. Additional behavior certifications include Passive Avoidance Testing, Watermaze Testing, Reflex and Physical Development Testing (Air Righting, Auditory Startle, Eye Opening, Hair Growth, Negative Geotaxis, Pinna Unfolding, Pupil Constriction, Surface Righting and Tooth Eruption.

• Routes of Blood Collection certifications include auricular artery and marginal vein (rabbit), lateral tail vein (mouse and rat), vena cava (mouse and rat), tail snip (mouse and rat).

• Further certification consists of Cholinesterase Blood and Brain sample processing, milk collection (rat and rabbit), blood processing, micropipette and repeater pipette verification and use, and estrous smear evaluation.

• Quickly and precisely, respond to internal and external quality assurance audits. Erica Musser Resume

Research Technician III

Charles River Laboratories, Horsham, PA

2008 – 2010

• Performs clinical observations, sample collection and monitor food consumption of animals assigned to study

• Reviews study protocols and provides recommendations to study director and study supervisor on technical logistics and protocol design

• Ensures raw data records are accurate, complete, and in order, meet protocol specifications and/or GLP requirements.

Research Technician II

Charles River Laboratories, Horsham, PA

2007 – 2008

Research Technician I

Charles River Laboratories, Horsham, PA

2006 –2007

Education

University of Rhode Island, 2004

Kingston RI

B.S. in Animal Science

Minor in Psychology



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