Parexel- Clinical Data Coder I, Hyderabad

Job Title	Clinical Data Coder I
Functional Area	Data Management
Auto req ID	8586BR
Requisition #	pare-10026096
Location	India - Andhra Pradesh - Hyderabad
Why Work at PAREXEL	PAREXEL International Corporation is a leading global bio/pharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Perceptive Informatics, Inc., a subsidiary of PAREXEL, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process. Headquartered near Boston, Massachusetts, PAREXEL operates in approximately 70 locations throughout over 50 countries around the world, and has more than 13,000 employees. At PAREXEL, we have a passion for making a profound difference. As an expertise-based business, the caliber of our people and their dedication directly impacts our success, the success of our clients, and the ability to make a difference in the lives of patients worldwide. You’ll be surrounded by supportive leadership and a brilliant team who share a common goal — to improve the lives of millions of patients.
Job Description	Essential Function 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. Parameters Comply with Company policies, SOPs and Regulatory guidelines. Relationships Reports To Manager Directly Supervises N/A Provides Work Direction to N/A Works Closely with All project team members External Relationships N/A Key Accountabilities • 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 Skills • Good computer skills including but not limited to the knowledge of Clinical Trial/Data Management Systems, PMED, MS-Office products such as Excel, Word. • Demonstrate a 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) • Solid interpersonal, verbal and written communication skills • 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 Education • Bachelor’s degree and / or other medical qualification or relevant DM experience Language Skills • Competent in written and oral English
Qualifications	0 to 2 years; • No minimum work experience necessary for those with a Bachelor’s degree. Relevant data management, clinical and / or research experience preferred if no Bachelor’s degree