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IQVIA; Thane; On-site; INR 700,000 - 1,000,000; Full time

Job summary

IQVIA is seeking an on-site Clinical Monitoring professional to ensure sites conduct studies per protocol, regulations, and sponsor requirements. The role involves visits, training, communication with sites, and tracking regulatory submissions and data queries across assigned studies.

Ideal candidates have 1+ year of on-site monitoring, solid GCP/ICH knowledge, and strong organizational skills to manage timelines and documentation.

Qualifications

• Bachelor's Degree in scientific discipline or health care preferred.
• At least 1 year of on-site monitoring experience.
• Equivalent combination of education, training and experience may be accepted in lieu of degree.
• Good knowledge of applicable clinical research regulatory requirements (GCP/ICH).
• Good therapeutic and protocol knowledge as provided in company training.
• Computer skills including Microsoft Word, Excel and PowerPoint; use of laptop and mobile devices.

Responsibilities

• Perform site monitoring visits per scope of work and regulatory requirements (GCP/ICH).
• Drive and track subject recruitment plan to support project needs.
• Administer protocol and training to sites and maintain regular communication.
• Evaluate site quality and adherence to protocol and regulations; escalate issues.
• Track regulatory submissions, recruitment, CRF completion, data queries; may support start-up.
• Ensure TMF/ISF documents are complete and properly filed.
• Create visit reports, follow-up letters and site documentation.
• Collaborate with study team for project execution support.
• May support development of site recruitment plans and site budget invoices.

Skills

Site monitoring

GCP/ICH knowledge

Communication skills

Time management

Team collaboration

Education

Bachelor's Degree in science/healthcare

Equivalent education/experience

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Job Overview

Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Essential Functions

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation
• Collaborate and liaise with study team members for project execution support as appropriate
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis
• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement

Qualifications

• Bachelor's Degree Degree in scientific discipline or health care preferred. Req
• Requires at least 1 year of on-site monitoring experience. Req
• Equivalent combination of education, training and experience may be accepted in lieu of degree. Req
• Good knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines)
• Good therapeutic and protocol knowledge as provided in company training
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable)
• Written and verbal communication skills including good command of English language
• Organizational and problem-solving skills
• Effective time and financial management skills
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

Learn more at https://jobs.iqvia.com

We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere.

Thank you for your interest in growing your career with us.