Diane Shadrach

*** *** ***** ***********, ** ****6

919-***-**** (c)

Objective: To seek a position that utilizes my skills in data validation, user acceptance testing and management of multiple ongoing projects.

Expertise

Over 10 years of database validation and user acceptance testing for clinical trials

Over 10 years of management a data entry group in a clinical research setting

Multitasking, ability to work on and manage multiple projects concurrently

Strong interpersonal and organizational skills

Strong written and verbal communication skills

Ability to work in electronic systems, software systems and web based applications

Ability to work in team environment

Production Quality Management

Management of resources to ensure appropriate allocate based on project

Strong Data Entry Skills 15,000ks/hr

Positive and successful interaction with client

Professional Experience

GLAXOSMITHKLINE Outsource Group/DOCS/ICON, Durham, NC Jan 2015 – Present

Manager/ Quality Control Specialist

Manage team that supports various activities for the clinical data management team

Responsible for resource allocation, quality control, training, and budget oversight

Tracks and documents all testing

Performs test builds of the EDC system.

Submit test builds to Oracle for implementation.

Performs a quality assurance check so the data extraction and transformation output versus the EDC system input.

Generates listings and other supporting documentation related to the other quality control functions.

GLAXOSMITHKLINE Outsource Group/ClinForce, Durham, NC Nov 2009 – Feb 2015

e Clinical Data Specialist

Perform validation and testing of the eCRFs and edit checks.

Enter test data into the EDC (electronic data capture)

Study file archiving for TMF (trial master file)

Working with client data standards group for the creation of study specific variables

QC of test data entry plans to ensure extraction of data in to appropriate datasets

SC Data, Raleigh, NC

Site Manager/Vault Manager 2006 – 2009

Data Entry Coordinator 2001 – June 2006

Data Entry Supervisor 1995 – 2001

Computer Operator 1987 – 1995

Data Entry Lead Operator 1981 – 1987

Data Entry Operator 1979 – 1981

Responsible for the seamless operation of the day-to-day business of the company

Work closely with the company owner to meet staffing, equipment and organizational needs

Train new employees on company operating procedures

Maintain ADT card access, monitor cameras, doors, alarm systems

Discuss with supervisors workflow, and procedures

Assures policies and procedures pertaining to the company is followed

Provide training to entry staff at SC Data

Provide feedback to entry staff on quality and quantity of work to improve the entry process

Primary contact to the sponsor organization

Coordinate with sponsor organization on timelines, guidelines, and auditing

Achieved customer satisfaction by working to proactively resolve issues

Maintain appropriate protocol documentation

Train all data entry operators on new protocols

Oversaw the operation of computer hardware systems, ensuring that these machines were used as efficiently and securely as possible

Communicated well and worked effectively with programmers, users, and other operators

Software Experience

InForm

Oracle Clinical

Microsoft Windows

Office 2013/2016

Education

Bunn High School 1978-1979

Youngsville High School 1975-1978

References

Available upon request

Contact this candidate