IQVIA Released Job Openings On 30/07/2022.The Company offers commercial, physical, and biological research and development services, as well as value-based analyses, research studies, clinical management analytics, and health outcome optimization services.Application form link provided at the end of post. Eligibility for the Site File Associate as follows.
Vacancy Details:
IQVIA Recruiting B.Pharma,B.Sc Graduate with 01-05 Years Experience for Site File Associate Position.Complete Details for the Site File Associate as follows.
Important Details :
- Location : Kochi/Cochin, Thane, Bangalore/Bengaluru
- No of Vacancies:Not Disclosed by Recruiter
- Details of Salary: NA
- Opening date for online Application: 30/07/2022
- Mode of application :Online
- How To Apply: At the End of the Article We Have Provided Source Link,Please Go through that and Follow Necessary Steps
Related Job: Glenmark life sciences Looking For FRESHERS – 50 OpeningsÂ
Job Description/Skills Required
Responsible for the quality and regulatory compliance of Investigator Site Files (ISF) during the file maintenance period of the study. Work with both internal and external teams to assure good communication regarding documentation processing. Assure documents maintained for a study are in compliance with International Congress on Harmonization-Good Clinical Practices (ICH-GCP), country regulatory requirements and procedures set forth by IQVIA Biotech and its clients. Site File Associate will work in conjunction with or under the supervision of a more senior Site File Specialist or Lead.
- Review site level documentation to ensure compliance with GCP and IQVIA Biotechs standard operating procedures from maintenance through close-out phase. Reviews investigator study files and identifies expired documents, upcoming continuing renewal where applicable.
- Communicates directly with local CRAs in various countries, to obtain corrections to incomplete/incorrect/expired documents.
- Tracks any action items to CRAs/sites in CTMS or alternative process as per the client requirement.
- Complete Periodic Site File Reviews per the IQVIA Biotech SOPs.
- Follows the appropriate IQVIA Biotech and/or sponsor SOPs during conduct of the study.
- Ensures all project documentation is appropriately filed per IQVIA Biotech SOPs, or Sponsor SOPs if required.
- Adheres to study timelines, document/escalate study challenges and communicates update to Site File Specialist/Lead.
- Performs other duties as required.
Click here for notification and Apply
