Opening for Clinical Data Coder II in Parexel - freshers may apply
PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries. They have helped over 800 clients to develop and launch some of the most important drugs and devices of our time-helping people live better and healthier lives everywhere in the world. Headquartered near Boston, Massachusetts, PAREXEL operates in more than 50 countries around the world.
Post: Clinical Data Coder II
The role of the Clinical Data Analyst (CDA) is to perform all clinical data cleaning activities on assigned projects, commensurate with experience and/or project role. Key activities include data validation, generation and integration of queries, coding of clinical data, reconciliation of safety and electronic data.
The Clinical Data Analyst will assume the Clinical Data Manager responsibilities on studies that started before July 1st 2009.
Comply with Company policies, SOPs and Regulatory guidelines.
Reports To Manager
Directly Supervises N/A
Provides Work Direction to N/A
Works Closely with All project team members
External Relationships N/A
• 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
• 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 regular interaction / supervision by Manager or assigned mentor
• Maintain a working knowledge and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements and PAREXEL WSOP and stud specific procedure
• Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, travel expense claims
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