Clinical Data Specialist

Proclinical is currently recruiting for a Clinical Data Specialist with a biopharmaceutical company located in North Chicago, IL.

Job Responsibilities:

• Implement and maintain the effectiveness of the data quality system.
• Review Draft Protocols and provide comments on aspects of study that impact study set up, data collection and transmission, and workflow and implications for external client groups Sponsor/vendor).
• Ensure the design of clinical data collection and management systems in the conduct of clinical research trials accurately reflect the protocol requirements and needs of external client groups (Sponsor/vendor).
• Aligns DS study team with program- and study-level analytics strategies. For assigned studies, works with Data and Statistical Sciences (DSS), Data Warehouse Analyst, Statistical Programmer and Statistician to ensure the context, accuracy and timeliness of clinical data collection and management systems are optimized.
• Connects with cross-functional teams to design work product and as an analytics consultant
• Contributes to study execution 'lessons learned' across functions
• If assigned, assist in the alignment of data management systems with additional trial systems (e.g., EDC, IRT, ePRO).
• Liaises with DSS, Monitors, Statistics or others involved to facilitate discrepancy management in clinical trials.

Skills and Requirements:

• Bachelor's Degree
• 2 years in Clinical Research
• 2 years' experience with Clinical research data systems
• Electronic source systems experience preferred
• Able to work independently as well as in a team environment and with all levels of personnel within the organization to achieve the desired outcome with guidance.
• Must be able to make sound decisions based on situation at hand, understand when more information is needed to make a sound decision and assume responsibility for the outcome of the decision.
• A working knowledge of data management and the ability to apply that knowledge to a wide variety of situations and to propose potential solutions to management and clients.
• A working knowledge of the research and development of pharmaceuticals, all applicable regulations, GXP, GCDMP and SOPs and a clear understanding of the effect of his/her decisions on the successful conduct of clinical research studies and subsequent submission to regulatory authorities.

If you are having difficulty in applying or if you have any questions, please contact Zachary Hines at 215-531-6914.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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