Clinical Data Specialist Resume

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A clinical data specialist provides administrative services in biotechnology industries. The job profile of a clinical data specialist includes collecting, analyzing and ensuring the integrity of data collected in a clinical trial setting. The role also shoulders the responsibility of developing systems to document and test clinical data studies as well as conduct quality control checks to ensure data integrity for medical review and implementation.

Clinical Data Specialist Resume Example

Career Objective:

A Biotechnology graduate adept in standard clinical procedures of the FDA and experience in supervising clinical data management processes seeks to lend my expertise to a reputed and innovation centered organization.

Core Competencies:

• Comprehensive knowledge of the procedures and clinical practice standards of Federal Drug Administration
• In-depth knowledge of the processes of clinical data management systems, clinical trial methodology, GCP and medical terminology
• Extensive knowledge of programming platforms like PL/SQL, Structured Query Language and statistical software
• Skilled in mentoring, coaching, training internal and external partners
• Outstanding communication and presentation skills
• Possess strong organizational and time management skills
• Ability to work under pressure and meet deadlines

Professional Experience:

Organization: Digilite Group, California
Duration: June 2011 till date
Designation: Clinical Data Specialist

• Handle the tasks of supervising and coordinating in various activities of Clinical Data Management services
• Responsible for providing effective Data Management input to global clinical teams
• Perform responsibilities of preparing database lock and perform maintenance of clinical trial study workbooks
• Handle the tasks of providing clinical data management training to clinical trial team members and external clients
• Responsible for generating summary reports and listings for the Clinical Department
• Handle responsibilities of coordinating in trial activities with biostatistician and clinical team
• Perform the tasks of drafting, reviewing and executing test plans for CDM programs

Organization: Dmenic Services, California
Duration: April 2009 to May 2011
Designation: Senior Clinical Data Management

• Serve as a primary contact for the client, communicating client timelines and deliverables to the clinical staff
• Responsible for supporting clinical project teams in managing information flow and data collection in accordance with appropriate regulatory and departmental guidelines
• Perform the tasks of documenting project-specific data management and data entry guidelines to ensure consistent and efficient processing of data
• Handle responsibilities of assisting clinical data specialist in areas of documenting, testing, and implementing clinical databases
• Review and validate all data generated from the project, including the reconciliation of external data
• Coordinate in the execution of data validation programs as well as generate queries on potentially discrepant data
• Handle the tasks of maintaining data management project file documentation, finding and reporting the status of data management activities

Educational Summary:

Achieved Bachelor's degree in Biotechnology
University of California in the year 2009

Reference:

Will be furnished upon request.