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 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.
Candidate Profile:
• Bachelor’s degree and / or other medical qualification or 3-6 years of relevant DM experience
• Previous data management experience preferred, or clinical and / or research experience with solid understanding of clinical trials methodology and terminology
Additional Information:
Experience: 3-6 Yrs
Location: Andhra Pradesh - Hyderabad
Functional Area: CR
Industry Type: Pharma/ Biotech/Clinical Research
Employment Type: Full Time
Job Type: Regular
End Date: 20th Feb., 2014
Req ID: pare-10031196
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