Clinical Data Coder I...Parexel..m

Clinical Data Coder I

DepartmentData Management JobsLocationHyderabad, Andhra Pradesh, India

Apply Here :http://jobs.parexel.com/in/hyderabad/data-management/jobid4236259-clinical-data-coder-i-jobs 

Job Description : 
Key Accountabilities - Assume the ability to meet the requirements of a CDA I with a high degree of proficiency and autonomy - Take responsibility for specific tasks on projects, or acts as the main CDA contact on individual projects - Train team members on selected tasks - Prepare Data Cleaning Specification - Review the Data Validation Specification prepared by the Technical Analyst in GTS - Develop or provide input to project specific guidelines, e.g. SAE handling. - Initiate the running of study specific programs - Utilize current study documentation including protocol, Case Report Forms (CRFs), Cleaning guidelines etc. - Conduct in-house data review, - Generate and close queries or apply self evident corrections to the data according to the relevant guidelines - Identify and report protocol violations - Manual and Patient Profile review, issue queries - Conduct reconciliation of SAEs, send out queries as required and notify relevant Safety Groups of possible issues for their action - Track and integrate queries - Perform clinical coding if appropriate to role within the project team - If required liaise with 3rd party vendors to clean electronic data - Ensure all documents coded for submission to central files - Lock site(s) within EDC system - remove user's data modification privileges - Interact with site (via mail) as required - Perform early and final database QC activities - Update all relevant tracking system on an ongoing basis - Inform responsible CDA Coordinator of work status regularly - Keep Manager informed about work progress and any issues to avoid surprises. Requires some interaction / supervision by Manager or assigned mentor Skills - Good computer skills including but not limited to the knowledge of Clinical Trial/Data Management Systems, PMED, knowledge of MS-Office products such as Excel, Word - Sound awareness of all relevant regulations, including GCP - Ability to successfully work in a (`virtual-) team environment - Client focused approach to work - If required, knowledge of medical terminology and awareness of coding dictionaries (e.g. MedDRA & WHODRUG) - Effectively applies knowledge to provide advice or solutions based on expertise - Offers support and constructive feedback to project team members - Seeks opportunities to develop experience and knowledge - Ability to organize and plan tasks - Excellent interpersonal, verbal and written communication skills - Must be able to work independently but seek guidance when necessary, escalating issues as required - Sense of urgency in completing assigned tasks - Meticulous attention to detail - Effective time management in order to meet daily metrics or team objectives - Shows commitment to and performs consistently high quality work - Willing and able to travel as required - local or international

Qualifications : 
2 - 4 yrs

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