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Career Opportunity in Parexel | Join as Quality Specialist, Clinical Data Analyst I (Coder), Clinical Database Programmer II, Quality Specialist II


Post: Clinical Data Analyst I (Coder)

Job Description:
- Perform clinical coding within the project team (Experience of medical terminology and awareness of coding dictionaries (e.g. MedDRA & WHODRUG)
- Take responsibility for specific tasks on projects
- 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
- 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

Experience:
Skills
- Preferred knowledge of medical terminology and awareness of coding dictionaries (e.g. MedDRA & WHODRUG)
- 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
- 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

Education & Experience
- Educated to minimum of Graduation in Lifescience or equivalent - experience
- 1 year of relevant Clincial Data Coding
- Excellent English Communication skills

Additional Information:
Location: India - Andhra pradesh - Hyderabad
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR, Data management
End Date: 20th Jan, 2012

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