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 Monitoring Associate II
Job Description:
Create and maintain all clinical studies (approximately 100 studies) in CTMS on daily basis per data/reports received. All updates should be completed within 5 days of receipt of data/reports.
Provide necessary follow ups with the study team to ensure data completeness using the IMPACT reports and resolve any queries in a timely manner within 5 days.
Data to be created/maintained are:
- Addresses, telephone, fax and e-mail contact information for investigators, IEC/IRBs, and other site personnel for each study
- Company personnel for each study
- Study level milestones, protocol design information, recruitment plan, etc.
- Country level milestones, Regulatory Approval information, recruitment plan, etc.
- Site level milestones, recruitment information, etc.
For studies where data loading is being handled, checks and follows with the study teams will be required if errors are found during the loading process. Resolution should be within 5 days.
Provide support to end-users directly or by channeling requests to CTMS colleagues as appropriate
Compliance check should be completed on monthly basis using the Quality Check reports and follow up with study teams for any missing and data quality issues.
Data cleaning, new data entry, or rectification needed in CTMS.
Qualifications :
Individual’s Experience
Relevant experience in maintenance of computer-based records-
Previous experience in use of a clinical trial management system (CTMS) is preferable.
Individual’s Specific skills
Computer literate, especially in use and management of databases and spreadsheets reports
Basic understanding of the use of electronic systems in regulated environments is preferable.
Basic understanding of clinical development processes is preferable.
Good organization skills.
Diligent and reliable
Reasonable competence in spoken and written English.
Individual’s Problem solving
Able to recognise problems/potential problems and alert management and/or take action as appropriate.
Able to prioritize routine work
Additional Information:
Location: Andhra Pradesh - Hyderabad
Functional Area: CR
Industry Type: Pharma/ Biotech/Clinical Research
Employment Type: Full Time
Job Type: Regular
End Date: 30th June, 2014
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