Multiple vacancies in Parexel: Require Senior Quality Specialist/Quality Specialist II, Research Operations Assistant, Quality Manager, Clinical Data Analyst II

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Post: Clinical Data Analyst II

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

* 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

2 to 4 years

Additional Information:
Location: Andhra Pradesh - Hyderabad
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 7th Oct, 2012
Req Number: pare-10016010

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