Mutliple Vacancies at PAREXEL

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Clinical Data Analyst II

Job Location:  Bengaluru, Karnataka, India

  • Demonstrates full competence when conducting the following tasks:
    ‒ Development of database build specifications
    ‒ Development of data validation specifications
    ‒ Test data creation & UAT
    ‒ Performing/ leading functional QC activities and testing
    ‒ Create CRF Completion Guidelines (CCG), SAE reconciliation Guidelines, etc.
    ‒ Data validation and cleaning
    ‒ Conduct medical coding if assigned
    ‒ Conduct SAE & third party data reconciliations
    ‒ Perform early and final database QC activities
    ‒ Database lock activities
    ‒ Maintaining Clinical Study Documents and archiving as appropriate
    • Responsible for completeness, timely delivery and quality of clinical data
    • Learning role of Primary CDA
    • Act as a single point of contact (internal expert) for specific processing task(s) on a project
    • Support site monitoring personnel to retrieve missing data as required
    • Other assigned responsibilities as needed

 




 

Qualifications

Must be able to demonstrate proficiency with several tasks included in data start-up through data-base lock. Previous relevant 2 to 4 years data management work experience required with solid understanding of clinical trials methodology and terminology required.

ABOUT PAREXEL:

PAREXEL strives to be the premier provider to the biopharmaceutical and medical device industries for the development and commercialization of new medical therapies worldwide.

CLICK HERE TO APPLY



Medical Writer II

Job Location:  Bengaluru, Karnataka, India
Summary:
Under departmental supervision, the Medical Writer II will research, create, edit, and coordinate the production of clinical documents associated with submissions to regulatory authorities including but not limited to: study protocols, model informed consents, interim and final clinical study reports and safety updates. The Medical Writer II will also be responsible for the production of clinical study documentation associated with clinical trials that may not be included in a regulatory submission. The Medical Writer II may serve as primary technical contact with client under appropriate departmental supervision.

Write clinical documents associated with submissions to regulatory authorities including but not limited to: study protocols, model informed consents, interim and final clinical study reports and safety updates.
Serve as the primary client contact, negotiating deliverable timelines, and resolving project related issues, under departmental supervision.
Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copyediting and content review.
Ensure document content and style adheres to FDA/EMA or other appropriate regulatory guidelines, and complies with departmental and corporate or client SOPs and style guidelines.
Qualifications
Medical writing experience: experience in writing multiple clinical study reports or other regulatory documents.

ABOUT PAREXEL:
PAREXEL strives to be the premier provider to the biopharmaceutical and medical device industries for the development and commercialization of new medical therapies worldwide.
CLICK HERE TO APPLY





 




 
 




 

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