CLINICAL TRIAL SPECIALIST JOB POSTS-NOVARTIS HYDERABADNovember 13th, 2009 Posted by VFreshers
Clinical Trial Specialist Job Openings India at Hyderabad / Secunderabad – Novartis
Job Title : Clinical Trial Specialist
About Company :
A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes us one of the most rewarding employers in our field.
Experience : 1 – 2 Years
Job Location : Hyderabad / Secunderabad
Job Description :
- Check technical compliance of clinical submission documents and clinical documents related to a trial or program (e.g., protocol, study report, Investigator Brochure)
- Ensure documents are published in the electronic documentum repository (CREDI) on time to support clinical milestones (e.g., submission to health authorities, initiation of trials, reporting of study results)
- Support archiving and posting of trial information in required clinical repositories (e.g., Trial Master Files, Clintrial.gov)
- Support collection of published scientific references and import into CREDI ensuring correct format and naming conventions in clinical submission documents (e.g., expert statements, clinical overview)
- Perform specified quality checks (QC) on clinical documents and clinical data (Sr CTS)
- Generate specified clinical trial tracking reports to assist teams with monitoring progress of trials (Sr CTS)
- Coordinate clinical trial scale activities (Sr CTS)
- Excellent word processing skills with advanced MS Word are required.
- Proven experience working with computers
- Experience working with the documentation system using Novstyle and the document repository for clinical documents is advantageous
- Strong intrapersonal skills, customer focused, and ability to work independently managing multiple priorities across a global organization.
- Well-organized, detail-oriented and excellent follow-up skills
- Good oral and written communication skills are required
- Working knowledge of the various types of clinical documents is helpful.
- Basic understanding of the clinical drug development process, Good Clinical Practice and familiarity with medical terminologies is a plus.
- A bachelor’s degree or equivalent qualification or work experience is required.
Website : http://www.novartis.com
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