Traci Alexander

*** ******* ***

Lansdowne, PA **050

ab85wy@r.postjobfree.com

Home 610-***-****

Mobile 215-***-****

SENIOR CLINICAL DATA ANALYST

An experienced clinical research professional that combines four primary job roles with a high

degree of proficiency and autonomy to excel as a Data Manager.

Subject Matter Expert (SME):

Core knowledge and understanding of medical and pharmaceutical terms, concepts, and data

management guidelines.

Ongoing detailed knowledge of study data requirements to facilitate data reconciliation, coding,

review and clarification activities.

Knowledge and use of clinical data management methodologies.

Data Entry Specialist:

Prepare source data for computer entry by compiling and sorting information; establishing entry

priorities.

Maintain data entry requirements by following data program techniques.

Maintains customer confidence and protects operations by keeping information confidential.

Data Analyst:

Implemented procedures, data standards, and data coding dictionaries across oncology studies.

Performed data management review and reconciliation of patient study data captured during

clinical trial study.

Reviewed data requirements, write detailed specifications, and developed queries to meet project

scope.

Write SQL queries to analyze large data sets for data reconciliation.

Import large sets of data from external vendors to resolve queries in compliance with required

timelines and guidelines.

Data Steward:

Performed all aspects of the data management process, ensuring compliance with FDA

regulations related to data management.

Performed data quality validation, identifying and resolving data discrepancies and

making corrections to data. Managed and reconciled external laboratory data for oncology and

cardiovascular studies.

Data Manager:

Executed data management plans for the design, and implementation of data collection, review,

clarification and reporting systems for clinical studies.

Performed study design, setup and closeout functions as a Lead Data Manager on Phase I &

Phase II clinical trials.

Coordinated the tracking and management of study activities to ensure timely activities and

appropriate collaboration with external vendors, meeting all project deadlines.

Mentored and trained new data analysts on best-practice data management techniques.

Therapeutic Experience: Oncology; Pulmonology; Neurology (e.g. Alzheimer, Sleep Disorders);

Endocrinology Immunology/ Oncology (e.g. HIV); Ophthalmology; Cardiovascular; and

Rheumatology.

EDUCATION

Certification in Web Design/Development, Delaware County Community College, September 2012-

Present

Traci Alexander

Home 610-***-**** ab85wy@r.postjobfree.com Mobile Phone 215-***-****

B.S. Degree in Computer Information Systems, Strayer University, Springfield

Major: Homeland Security, Concentration: Internet Security (Expected Graduation) currently on hold

A.S. Degree in Science for Health Professions, Delaware County Community College Apr 2005

Professional Experience

Contemporary Staffing Inc February 2013-Present

Data Entry Specialist

• Perform data entry and data review of mobile/ medical alert devices into sales force database.

• Review contractual data for any incorrect or missing responses.

• Review credit card information and report any declined or invalid entries.

• Provide excellent customer service with resolving issues and discrepancies.

ExecuPharm, Inc Oct-2011-Jun 2012

CCTR Data Entry Specialist

Clinical Registry

• Review and correct study/center data points in Client Registry as directed by Remediation Lead.

• Write SQL relational queries to choose or select data to be analyzed.

• Prepares source data for computer entry by compiling and sorting information; establishing entry priorities.

• Review required study/center data point information with Remediation Lead and make required

changes/entries to Client Registry.

• Partner with Client registry Business Administrator to override business rules as required.

• Perform relational QC as required between system and documentation as directed by Remediation Lead.

• Verifies entered source data by reviewing, correcting, deleting or reentering data; combining data from both

internal system and registry when information is inaccurate.

• Responsible for meeting client productivity metrics.

• Provide excellent customer when interacting with staff and clients.

• Responsible for review and correction for all non-registry studies. (special project)

• Contributes to team effort by accomplishing related results.

• Provide excellent customer service when interacting with clients and customers.

• Parx Casino Jul-2010-Oct-2011

• Player Services

• Poker Dealer

• Assist poker players in a customer service environment.

• Provide excellent customer service s to staff and clients.

• Answer phones and assist customers with answers to questions concerning casino

• State License Poker Dealer

• Assist staff with keeping the poker room environment in a neat manner.

Traci Alexander

Home 610-***-**** ab85wy@r.postjobfree.com Mobile Phone 215-***-****

• Assist high rollers with any concerns and make sure their visit at the casino meets their expectations.

• QUALITY DATA SERVICES Jul-2008–May-

2009

• Senior Clinical Data Manager/Analyst

• Oncology

• RDC and Inform EDC exp

• Managed daily data operation of Phase I and Phase II Oncology trials to ensure client satisfaction and meet

company goals, including quality, timelines and budgetary milestones. Managed the quality and completeness

of clinical studies databases.

• Developed and reviewed study specific start-up documents, Data Management Plan, eCRF Completed

guidelines, specifications and Data Entry Instructions on EDC studies.

• Designed eCRF using specifications and protocol requirements.

• Assist with development and monitoring of study metrics and status reports.

• Acted as a liaison with sponsor and third party vendors to import and manipulate large data sets, resolve

queries and address study issues.

• Interfaced with external data vendors as well as IT staff to ensure query resolution in compliance with

required timelines.

• Performed project management duties to include study budget, site training and monitoring.

• Oversee study-specific global listing review and database closure activities.

• INC RESEARCH Nov-2006–Jul-

2008

• Clinical Data Analyst/Lead Data Manager

• Oncology

• Oracle RDC and Meta Rave EDC experience

• Performed as a Lead Data Manager on Phase I, Phase II, Phase III, Clinical Trials Remote Data Capturing

Studies and Electronic Data Capturing studies. Worked directly with clients to prepare and agree on all

specifications.

• Developed study-specific plans (i.e. data management plans, data validation plan including edit check writing,

data quality plans, data entry, data entry guidelines, data tracking guidelines, TMS, CRF completion

guidelines and electronic data interchange plans).

• Represent Data management at internal/external meetings.

Traci Alexander

Home 610-***-**** ab85wy@r.postjobfree.com Mobile Phone 215-***-****

• Understand sponsor contracts with regards to Data Management activities.

• Provide feedback o client and senior management in the development of timelines and changes as

appropriate.

• Assist with the development and validation of CRF’s and Electronic Case Repot Forms.

• Create and wrote SQL queries accurately to analyze large data sets for generating in data queries to resolve

data discrepancies and provide proble resolution.

• Appropriately address responses related to data queries and accurately update the clinical data as needed.

• Interface with external data vendors as well as IT staff to extract and manipulate large sets of data for query

resolution.

• Independently and accurately prepared database test documentation and tested data entry screens.

• Performed User Acceptance Testing (UAT) and analysis of Data Entry Screens.

• Worked with Project Managers in translation of customer needs in terms of study presentation and system

functionality.

• K-FORCE Clinical Research- Contracted to Aug-2006–Nov-

2006

• PharmaNet Clinical Research

• Data Analyst

• Oncology-Clintrial/Oracle experience

• Updated data management files and SOP’s for ongoing oncology studies.

• Perform UAT testing on data entry screens.

• Write SQL queries to select raw data to be analyzed and cleaned.

• Performed data review, query generation and resolution, and database closure activities.

• Perform Lab reconciliation

• Tracked milestones and provided updated reports to project team and other data analysts.

• Adverse and Serious Adverse Event reconciliation.

• K-Force Clinical Research- Contracted to

SANOFI--AVENTIS PHARMACEUTICAL COMPANY Jul-2005–Aug-

2006

• Data Analyst, Clinical Data Coordinator

• Clintrial exp

• Ran validated edit check programs, and defined and proposed any necessary edit updates

• Provided quality data review for completeness, inconsistencies, erroneous and missing data according to data

review plan.

• Reviewed DCF/sDCF and updated database; re-queried as needed.

• Created listing for Adverse and Serious Adverse events reconciliation and reconciled any third party data (i.e.)

EKG and laboratory data

• Perform AE and Conmed reconciliation.

• Perform UAT Testing.

Traci Alexander

Home 610-***-**** ab85wy@r.postjobfree.com Mobile Phone 215-***-****

• ICON CLINICAL RESEARCH Sep-

2003–Jun-2005

• Clinical Data Coordinator

• Oncology and Pulmonary exp

• Oracle and Clintrial exp

• Reviewed and maintained protocol documentation

• Developed and obtained required approvals of data validation guidelines for appointed studies.

• Annotated Case Report Forms and participated in database design.

• Created data specifications and design documents. Reconciled external data (Labs, EKG).

• Reconcile Adverse and Serious Adverse Events

• Perform data reconciliation including labs and conMeds.

• KELLY SCIENTIFIC RESEARCH (contracted to Merck Pharmaceutical) Dec-2002–

Aug-2003

• Data Management Associate

• Performed data management, data quality activities, and database updates on Endocrinology (Diabetes)

studies.

• Monitored external EKG and Labs.

• Perform data review and reconciliation.

• Perform QC listings review.

• GLAXO SMITHKLINE (formerly Smith Kline Beecham) Mar-1993–Nov-2002

• Clinical Project Leader/ Clinical Trials Coordinator (1993–1999)

• Promoted through a series of increasingly responsible positions. Managed clinical trials studies from start-up

to final data transfer for various therapeutic units.

• Perform data review /reconciliation on Endocrinology studies (diabetes).

• Ran validated edit check programs, and defined and proposed any necessary edit updates.

• Adverse and Serious Adverse Event reconciliation.

• Executed clinical data management duties; including, tracking of clinical database, requisition preparation,

center assignment, and delivery of laboratory testing supplies, and client services.

• Acted as liaison with investigators, clinical units, and clinical data management department with the goal to

familiarize them with clinical laboratory processes and testing procedures.

• Performed all aspects of project management including forecasting, tracking and meeting timelines, and

supervising and mentoring new staff.

• Technology Profile

• Clintrial, Oracle Clinical, RDC, EDC 4.50 including Datatrak, Medidata Rave, Inform and home based EDC

systems. SQL, SAS data sets exp. CTMS

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