Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.

• 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 Investigators 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.

Role: Pharmaceutical & Biotechnology - Other

Industry Type: Analytics / KPO / Research

Department: Research & Development

Employment Type: Full Time, Permanent

Role Category: Pharmaceutical & Biotechnology

Education

UG: B.Pharma in Any Specialization, BHMS in Any Specialization, BAMS in Any Specialization, BDS in Any Specialization

PG: M.Pharma in Any Specialization

About company

IQVIA is a leading global provider of advanced analytics, technology solutions and contract research services to the life sciences industry. Formed through the Merger of IMS Health and Quintiles, IQVIA applies human data science leveraging the analytic rigor and clarity of data science to the ever-expanding scope of human science to enable companies to reimagine and develop new approaches to clinical development and commercialization, speed innovation, and accelerate improvements in healthcare outcomes. Powered by the IQVIA CORE, we deliver unique and actionable insights at the intersection of large-scale analytics, transformative technology, and extensive domain expertise as well as execution capabilities. With approximately 86,000+ employees, we conduct operations in more than 100 countries

IQVIA has also featured in FORTUNEs 2023 List of World’s Most Admired Companies”. At IQVIA, you will have the opportunity to build your career, while helping our customers drive human health outcomes forward. We dedicate our experience, resources, and reputation so that you can drive your career and choose the path that best defines your development and success.