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PAREXEL Opening for Clinical Data Analyst I & II

By: JobSearch | Views: 1400 | Date: 06-Jan-2013

PAREXEL Opening for Clinical Data Analyst I & II.PAREXEL International is a growing, fast-paced, global Clinical Research Organization (CRO) that has helped bring to market 49 of the top 50 selling pharmaceuticals. In fact, we have worked with all 10 of the world's top 10 pharmaceutical companies.Given our breadth of expertise and the trust placed in us by major pharmaceutical companies worldwide, PAREXEL can provide you with a number of career options in Clinical Research that can rarely be found within ju


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PAREXEL International is a growing, fast-paced, global Clinical Research Organization (CRO) that has helped bring to market 49 of the top 50 selling pharmaceuticals. In fact, we have worked with all 10 of the world's top 10 pharmaceutical companies.

Given our breadth of expertise and the trust placed in us by major pharmaceutical companies worldwide, PAREXEL can provide you with a number of career options in Clinical Research that can rarely be found within just one company. In fact, over 25% of the positions opened at PAREXEL are filled by current employees working to advance their skills and careers.

Designation:Clinical Data Analyst I - 4 Opening(s)


Job DescriptionKey
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

Experience:
1 to 2 Years

Desired Profile:Please refer to the Job description above

Experience:1 - 2 Years

Industry TypePharma / Biotech / Clinical Research

RoleOther

Functional AreaOther

EducationUG - Any Graduate - Any Specialization, Graduation Not Required 
PG - Any Postgraduate - Any Specialization, Post Graduation Not Required 
DOCTORATE - Any Doctorate - Any Specialization, Doctorate Not Required
Compensation:INR 2,00,000 - 3,50,000 P.A
LocationHyderabad / Secunderabad
KeywordsCase Report Forms
ContactPAREXEL International (India) Pvt Ltd 
Websitehttps://www.parexel.com
Job Posted03 Jan

Referencepare-10023781

To Apply Please Visit :http://jobsearch.naukri.com/job-listings-Clinical-Data-Analyst-I-PAREXEL-International-India-Pvt-Ltd--Hyderabad-Secunderabad-1-to-2-010113001356

2nd Opening for Clinical Data Analyst II


Designation Clinical Data Analyst II - 2 Opening(s)

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


Skills
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

Experience:
2 - 4 yrs

Desired Profile Please refer to the Job description above

Experience 3 - 6 Years

Industry TypePharma / Biotech / Clinical Research

RoleOther

Functional AreaOther

Education UG - Any Graduate - Any Specialization, Graduation Not Required 
PG - Any Postgraduate - Any Specialization, Post Graduation Not Required 
DOCTORATE - Any Doctorate - Any Specialization, Doctorate Not Required

Location Hyderabad / Secunderabad

KeywordsClinical Data Analys

Contact PAREXEL International (India) Pvt Ltd 

Websitehttps://www.parexel.com

Job Posted03 Jan

Referencepare-10023143


To Apply Please Visit:http://jobsearch.naukri.com/job-listings-Clinical-Data-Analyst-II-PAREXEL-International-India-Pvt-Ltd--Hyderabad-Secunderabad-3-to-6-010113001370


























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