Site Visit Report Reviewer in India at Jobgether
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Job Description
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Site Visit Report Reviewer based in India.
This role plays a key part in ensuring the quality, compliance, and accuracy of clinical trial documentation across multiple study sites. You will be responsible for reviewing monitoring visit reports from site qualification, initiation, monitoring, and close-out visits, ensuring alignment with regulatory standards and internal SOPs. The position sits at the intersection of clinical operations and quality oversight, contributing directly to the integrity and reliability of clinical research data. You will work closely with Clinical Research Associates, Clinical Operations Leaders, and project teams in a highly collaborative and regulated environment. The role requires strong attention to detail and the ability to track and follow up on critical study issues such as protocol deviations and adverse events. It offers meaningful exposure to global clinical trial operations and cross-functional project coordination. This is an ideal opportunity for professionals passionate about quality-driven clinical research and patient-impacting outcomes.
- Review site visit reports including qualification, initiation, monitoring, and termination reports to ensure compliance with ICH-GCP guidelines, SOPs, and study protocols.
- Track and follow up on open issues, protocol deviations, and serious adverse events until resolution and closure.
- Collaborate closely with CRAs, Clinical Operations Leaders, and study teams to ensure accurate and timely documentation.
- Conduct quality checks on Monitoring Visit Reports (MVRs) and ensure consistency, completeness, and regulatory alignment.
- Support periodic analysis of monitoring activities and communicate findings to project teams and stakeholders.
- Participate in project meetings and contribute to operational discussions as required.
- Assist Clinical Operations Leaders with additional tasks and reporting activities following appropriate training.
- Degree in biological sciences, pharmacy, nursing, or other health-related discipline (or equivalent relevant experience).
- Experience in site management or clinical research with understanding of clinical trial processes, methodology, and terminology.
- Strong knowledge of ICH-GCP guidelines, regulatory requirements, and clinical trial compliance standards.
- Excellent written and verbal communication skills with strong interpersonal abilities.
- High attention to detail with strong organizational and multitasking capabilities.
- Ability to work effectively in a virtual, global, and cross-cultural team environment.
- Strong analytical thinking and problem-solving skills with a proactive approach to issue identification.
- Proficiency in Microsoft Office tools and general computer literacy.
- Ability to manage workload efficiently and prioritize tasks in a time-sensitive environment.
- Flexible, collaborative mindset with willingness to learn and adapt in a complex environment.
- Opportunity to contribute directly to global clinical research and patient-focused outcomes.
- Exposure to international clinical trial operations and cross-functional project teams.
- Structured training and development within a regulated clinical research environment.
- Collaborative and supportive team culture with global interaction.
- Career development opportunities in clinical operations and quality oversight roles.
- Competitive compensation package aligned with industry standards.
- Work within a mission-driven environment focused on improving global health outcomes.