Site Report Specialist ( Home based)
- Iqvia
- 2 - 5 years
- India
- 4 years ago
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Job Description
IQVIA is a world leader in using data, technology, advanced analytics and expertise to help customers drive healthcare - and human health - forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.
The Role Purpose:
- Review Site Visit Reports (SVRs) to ensure they meet or exceed quality standards and support goals of quality,
- subject safety, data integrity and regulatory compliance. Use tools and techniques to ensure the efficient and
- effective review of Site Visit Reports and their associated attachments, in compliance with Quintiles SOP, ICH/ GCP
- guidelines, and protocol requirements.
Role Description:
- Oversee a caseload of SVRs for assigned studies, ensuring compliance to the protocol, processes, timelines, Quintiles/applicable SOPs, and GCP guidelines. Review SVRs to ensure findings requiring corrective and /or preventative action plans are documented and followed up to resolution, to ensure high quality reports.
- Participate on the project team for all SVR review activities and identifies and escalate CRA and /or site issues, relevant trends, and related risk factors to the project team and appropriate parties in a timely manner to optimize quality of project delivery.
- Provide guidance to Clinical Project Managers (CPMs) at project start-up and throughout the study and partner with the project team members to decrease the level of corrections/additions needed on reports by providing insight and training of the SVR annotations.
- Identify and track the project team compliance to SOPs for submission and approval of the SVRs through communication with the CRAs and line managers.
- Participate in meetings with project team to discuss any SVR review issues illustrative of
- quality/performance deficiencies across PIs/sites and CRAs. Assist with identification of the trends emerging from the Issue Escalation Log.
- Provide coaching to decrease the level of corrections/additions needed on reports.
- Provide quality improvement support such as quality checks, data trending, providing back up support and mentoring and coaching of junior staff members.
- May take on special project assignments related to function/corporate initiatives.
Minimum Required Education and Experience :
- Strong knowledge of and skill in applying, applicable clinical research regulatory requirements; i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Through knowledge and understanding of the Clinical monitoring processes and sound knowledge of clinical trial systems and applications
- Demonstrated skill in understanding and executing complex study designs as well as multiple studies
- Strong written and verbal communication skills.
- Effective time management and organizational skills, and the ability to manage competing priorities
- Ability to work independently with good analytical and problem solving skills
- Demonstrated ability to work across cultures and geographies with a high awareness and understanding of cultural differences
- High quality orientation, with a focus on attention to detail
- Ability to establish and maintain effective working relationships at all levels
If you think the above profile matches your dream role, please share your updated resume to La****************m@qu******s.com/sh***********e@iq**a.com
Job Classification
Industry: Pharma, Biotech, Clinical ResearchFunctional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology,
Role Category: R&D
Role: R&D
Employement Type: Full time
Education
Under Graduation: B.Pharma in Any SpecializationPost Graduation: Any Postgraduate in Any Specialization
Doctorate: Any Doctorate in Any Specialization, Doctorate Not Required
Contact Details:
Company: Iqvia Rds IndiaLocation(s): india
Website: https://www.iqvia.com/
Keyskills: Life Sciences Clinical Research site report clinical monitor Clinical Trials remote monitor
Iqvia
IQVIA, is an American multinational company serving the combined industries of health information technology and clinical research. It is a provider of biopharmaceutical development and commercial outsourcing services, focused primarily on Phase I-IV clinical trials and associated laboratory and ana...
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