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Position Summary :

· Serve as a resource for projects, deliverables, and improvement initiatives in the Data Management department.

· Perform data management activities to ensure the generation of accurate, complete, and consistent clinical data, and support timely project delivery to the highest quality.

· Ensure all activities are conducted in accordance with Good Clinical Practices (GCP), applicable SOPs, client requirements, and departmental requirements.

Job responsibility:

· Perform Quality Reviews and appropriately address all issues.

· *Compile and distribute necessary study documentation and maintain accurate and complete study files in accordance with all applicable procedures.

· *Identify and appropriately address data discrepancies in the clinical data via computerized edits and manual checks/listings.

· *Independently and accurately generate data queries to resolve data discrepancies.

· *Appropriately address responses to data queries and accurately update the clinical data as necessary.

· *Accurately and consistently apply data handling conventions to Case Report Forms as necessary in accordance with all applicable procedures.

· *Independently and accurately prepare database test documentation and test data entry screens.

· *Assist with the validation of edit check programs.

· *Assist with the development, review, and maintenance of relevant Data Management Study Specific Procedures.

· *Accurately perform Serious Adverse Event reconciliation in accordance with all applicable procedures.

· *Accurately perform external data reconciliation in accordance with all applicable procedures.

· Accurately perform case report form annotation.

· Provide input to, generate and distribute status reports as required, ensuring their accuracy.

· Represent Data Management at internal / external meetings as appropriate.

· Serve as a mentor for other staff in Data Management, and provide input to the performance appraisal process as requested.

· Undertake other reasonably related duties as may be assigned from time to time.

Experience

· To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

· Prior Clinical Data Management experience and ability to perform the activities in Section 2 of this document.

· Excellent accuracy, attentiveness to detail and capacity to maintain a high level of quality in work related tasks.

· Computer, keyboarding and word processing skills as relevant to the job function.

· Experience using clinical data management software and medical terminology. Working knowledge of Clinical Data Management data collection systems.

· Working knowledge of clinical database structures and annotated Case Report Forms.

· Ability to develop, read, understand, accurately interpret and follow procedures for all job related tasks.

· Understanding of Clinical Development Process and the role of Data Management.

Qualification :

Any life science

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