Technical Writer Resume

SUMMARY

Strict attention to details
Team player
Quick learner
Extensive knowledge regarding data management and clinical trial management
Proficient on various computer systems, including MAC OS, SAP, MS Office, DataFax, OC RDC, UNIX, Siebel CTMS
Experience with InForm, Medidata RAVE
Highly effective, efficient data manager with over 10 years experience in clinical data management, analysis and supply chain.
Focused on the details and importance to having accurate data for reporting and reacting accordingly with team and organizational objectives.
Achieved Master of Science in Information Technology specializing in Health Information Management Systems.

PROFESSIONAL EXPERIENCE:

Technical Writer

Confidential

Responsibilities:

Updated user document into CDISC language
Collaborate with team members for details needed in documents
Create, draft and finalize sponsor defined training and other informative documentation for team development

Clinical Data Coordinator

Confidential

Responsibilities:

Clinical Data Analyst

Confidential, MA

Responsibilities:

Increased responsibilities with regard to tracking of data issues and trends
Lead Clinical Device Manager for several studies
Monitor and track site discrepancies, following through to resolution
Provide increased input for job aides to assist training of new team members
Developed relationship with an internal business group for a global collaborative work - force
Increased responsibilities with development, coordination, and close-out procedures for system User Acceptance Testing

Senior Clinical Trial Coordinator

Confidential

Responsibilities:

Senior Clinical Trial Coordinator

Confidential

Responsibilities:

Perform device accountability of all available and expiring devices
Conduct expiring device return coordination with warehouse
Conduct shipments of devices to clinical trial sites
Verify sites have accurate numbers of devices and update database accordingly
Assist with tracking and filing of study documents
Coordinate the processing of device usages in the database, and completing reconciliation by ensuring clinical study sites are resupplied accurately

Assistant Consultant

Confidential

Responsibilities:

Senior Clinical Data Manager

Confidential

Responsibilities:

Clinical Data Specialist

Confidential

Responsibilities:

Lead Data Manager on all studies
Produce data management documentation including Data Management Plans Validation Procedures, and Work Instructions
Developed Cytyc’s Data Management Training curriculum
Assist Manager with auditing of several studies
Assist Manager and Director of Clinical Affairs with the locking of studies
Archive old data records and maintain record keeping of those archived folders
Perform study setup of all incoming studies
Assist Clinical Data Associate with CRF Design and Edit Check definitions
Respond to questions regarding CRF completion (CRAs and Study Site Coordinators)
Produce study reports as requested by team
Update CRF Completion Guidelines for ongoing studies
Create CRF Completion Guidelines for new studies
Assist Manager with preparation of data for the DSMB meetings

Clinical Data Manager

Confidential, MA

Responsibilities:

Assist Query Lead with prepping, sending, and receiving of CRF data queries
Assist team with query integration
Query Lead
SAE Lead
Electronic Data (Lab/ECG) Lead
Resolution of Medical Review Listings
Developed SQL scripts to search CRF for data
Assist Database Manager with loading of electronic data from FTP file to VMS server
Assist Data Managers with auditing of CRF data
Perform CRF data checks daily to meet set metrics
Assist Primary CDM with data point listings
Assisted Coding Lead with coding of Adverse Event terms
Perform device accountability of all available and expiring devices
Conduct expiring device return coordination with warehouse
Conduct shipments of devices to clinical trial sites
Verify sites have accurate numbers of devices and update database accordingly
Assist with tracking and filing of study documents
Coordinate the processing of device usages in the database, and completing reconciliation by ensuring clinical study sites are resupplied accurately