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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

Application process

Once you find a job opening that fits your skills and interests, you can create an account, apply and check back on the progress of your application or apply for other roles. Once your application has been received, a confirmation email will be sent to your email.

Remember: this is our first time meeting you. Read the job description and highlight on your CV those experiences that we should learn about.

One of our experienced recruiters will read your profile and determine if you're fit for the role and the company. We are aware of instances where fake recruitment text messages and emails that can appear to come from ICON have been received by individuals. Always delete suspicious text messages or emails. Never give out personal financial information.

Reasonable Accomodations

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