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 :

1. Check technical compliance of clinical submission documents and clinical documents related to a trial or program (e.g., protocol, study report, Investigator Brochure)
2. 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)
3. Support archiving and posting of trial information in required clinical repositories (e.g., Trial Master Files, Clintrial.gov)
4. 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)
5. Perform specified quality checks (QC) on clinical documents and clinical data (Sr CTS)
6. Generate specified clinical trial tracking reports to assist teams with monitoring progress of trials (Sr CTS)
7. Coordinate clinical trial scale activities (Sr CTS)

Desired :

1. Excellent word processing skills with advanced MS Word are required.
2. Proven experience working with computers
3. Experience working with the documentation system using Novstyle and the document repository for clinical documents is advantageous
4. Strong intrapersonal skills, customer focused, and ability to work independently managing multiple priorities across a global organization.
5. Well-organized, detail-oriented and excellent follow-up skills
6. Good oral and written communication skills are required
7. Working knowledge of the various types of clinical documents is helpful.
8. Basic understanding of the clinical drug development process, Good Clinical Practice and familiarity with medical terminologies is a plus.
9. A bachelor’s degree or equivalent qualification or work experience is required.

Website : http://www.novartis.com

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