SUMMARY

• Fifteen years of experience working in the Pharmaceutical industry and with Confidential Organizations ( Confidential ), expertly gathering and analyzing data for highly confidential clinical trials.
• Proficient in defining and validating protocols for clinical studies and handling trial responsibility throughout the data - management lifecycle.
• Advanced skills in EDC systems, well-versed in cGCP and FDA standards and regulations, and knowledgeable in therapeutic indications.

• EDC Systems (Medidata-RAVE, INFORM)
• MS Office (Word, Excel, Access, Outlook)
• Access based Work Management System
• Clincial Tria system based Clinical Data Entry
• Discrepancy Tracking System
• Confidential
• CRF Work Manager
• EDM
• iReview
• DDS

PROFESSIONAL EXPERIENCE

Confidential, Fort Washington, PA

Clinical Data Manager

Responsibilities:

• Review clinical data as per SOP, protocol, and study specific guidelines
• Issue queries within the clinical database for missing, inconsistent, illegible, or erroneous data; follow queries to resolution and close-out.
• Assist with study start up activities, including but not limited to test CRF mock-up and entry, database screen testing, and edit check testing
• Assist with all clinical data cleaning, including, but not limited to: external data cleaning, such as lab data review, Serious Adverse Event reconciliation, and taking appropriate action on terms that failed coding.
• Assist with any and all Clinical Data Management production activities, including but not limited to data dredging activities
• Assist with clinical database closeout activities, including but not limited to listing review, audit activities, etc.
• Communicate data issues and/or query trends to supervisor
• Interact with various Data Management and other functional area colleagues, including, but not limited to: Biostatistics and Programming, Clinical, Project Management, Safety, Medical Coding, site personnel.
• Assist with maintenance of all relevant documentation associated with each assigned Protocol.
• Provide assistance, mentoring, and/or training to Clinical Data Management staff such as Clinical Data Coordinators and/or Data Entry staff, as necessary.

Confidential, Tampa, FL

Senior Clinical Data Associate

Responsibilities:

• Review database structure for accuracy against annotated CRF.
• Review eCRF Review Guidelines.
• Review electronic case report form specifications/edit check specifications
• Review electronic case report form pages for logic and ease of entry
• Review study data, entered at site, for accuracy.
• Run manual edit checks in accordance with data review activities.
• Issue and resolve queries.
• Apply corrections to the database, as needed.
• Review eCRF and query tracking reports for accuracy.
• Participate in departmental meetings to maintain awareness of data issues.
• Run metrics on a weekly basis & provide results to Clinical Data Manager.
• Perform SAE and Lab reconciliation.
• Communicate trends in CRF completion to Clinical Data Manger.
• Communicate study specific issues to Clinical Data Manger/Project Team.
• Assist Clinical Data Manager in testing of project specific database/validation check.
• Interact with study coordinators and/or CRAs, when necessary.
• Review SAS validation check output and data listings.

Confidential, Malvern, PA

Clinical Data Coordinator

Responsibilities:

• Ran edit checks.
• Reviewed patient study data.
• Reviewed edit output.
• Wrote discrepancies.
• Made database corrections.
• Defined and proposed needed edit checks for a study.
• Created and maintained protocol documentation, including study file.
• Managed database set-up following standards.
• Proposed standard terminology for edits; entered/checked lab normals.

Confidential, Blue Bell, PA

Associate Data Management Specialist

Responsibilities:

• Ran data queries to identify issues requiring resolution.
• Sent queries to sites, when necessary, for clarification of any data issues.
• Communicated with study coordinators concerning data issues, on an as needed basis.
• Applied corrections to database, as required.
• Set visit milestones after visit was reviewed and all corrections were entered & verified.
• Ran metrics reports.
• Maintained protocol specified timelines.
• In 2006, took internal courses to learn electronic data collection & review.

Confidential, Media, Pennsylvania

Charge Nurse

Responsibilities:

• Scheduled for full-time day shift on a sub-acute floor with a fifty-two bed capacity.
• Ideally there were two nurses working day shift with one nurse giving medications and the other nurse in charge of treatments plus handling the desk duties.
• The position entailed distributing medications; treatments, as ordered; supervising nurse's aides; transcribing doctor's orders; scheduling outside appointments; arranging transportation; and any other duties assigned.

Confidential, Plymouth Meeting, Pennsylvania

Database Administrator

Responsibilities:

• Analyzed and coded supplier descriptions to in-house master file converters.
• Resolved unknown entries by research.
• Applied maintenance to files.
• Reviewed output of systematically linked data to ensure reasonableness of diagnosis and drug therapies.
• Researched and resolved any systematic problems.
• Owned and managed panel of doctors/medical practices that participated in study.
• Assisted in assembling, verifying, sending to print shop, and mailing to participants, a quarterly feedback report.
• Answered any questions physicians may have about reports.
• Maintained positive relationship with participating practices.

Confidential

Quality Analyst

Responsibilities:

• Performed database verification and correction on the raw and projected data for monthly publications as needed to improve client deliverables.
• Performed data investigation and prepared audits for print shop
• Interpreted and analyzed medical data from reporting physicians.
• Data elements included: patient diagnosis, drug products (form, strength, dosage & desires action), underlying conditions and patient demographics.
• Key business process included linkage between diagnosis information and drug therapy data. Investigation & problem resolution on inconsistent data elements.
• Coded reported data as specified by NDTI Coding Requirements.
• Enter coded data into database platform based on department productivity & quality specifications.

Confidential, Blue Bell, Pennsylvania

Health Care Trainer

Responsibilities:

• After one and a half years, promoted to trainer of Nutritional Specialists and Counselors in an area containing 5 centers.
• Maintained a close relationship with five center managers and a district manager.
• Various positions including: private duty nurse; charge nurse in long-term care facilities; and staff nurse on medical-surgical, oncology and short procedure unit in hospital setting.
• Performed variety of patient care duties including: dispensing medication, performing treatments, admission assessments, patient discharges, assisted with transfers, and any other duties as assigned.