This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Central Report Reviewer based in India.
In this role, you will play a critical part in ensuring the quality, consistency, and compliance of clinical trial reporting activities across global studies. You will review central monitoring documentation and site-level reports to ensure accuracy, completeness, and alignment with GCP, protocol requirements, and patient safety standards. The position is highly detail-oriented and contributes directly to safeguarding data integrity and regulatory compliance in clinical research. You will collaborate closely with clinical operations teams, including CRAs, Clinical Trial Managers, and project stakeholders, to identify risks and escalate issues when necessary. This role operates in a fast-paced, global environment where precision, scientific rigor, and communication are essential. You will also contribute to continuous improvement by identifying trends, reporting quality gaps, and supporting monitoring strategy execution across studies. The work directly supports the advancement of clinical trials and ultimately the delivery of new therapies to patients worldwide.
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Central Report Reviewer based in India.
In this role, you will play a critical part in ensuring the quality, consistency, and compliance of clinical trial reporting activities across global studies. You will review central monitoring documentation and site-level reports to ensure accuracy, completeness, and alignment with GCP, protocol requirements, and patient safety standards. The position is highly detail-oriented and contributes directly to safeguarding data integrity and regulatory compliance in clinical research. You will collaborate closely with clinical operations teams, including CRAs, Clinical Trial Managers, and project stakeholders, to identify risks and escalate issues when necessary. This role operates in a fast-paced, global environment where precision, scientific rigor, and communication are essential. You will also contribute to continuous improvement by identifying trends, reporting quality gaps, and supporting monitoring strategy execution across studies. The work directly supports the advancement of clinical trials and ultimately the delivery of new therapies to patients worldwide.
Accountabilities:
- Execute central report review activities in alignment with study monitoring strategies, ensuring compliance with protocol, GCP, regulatory, and patient safety requirements.
- Review and assess the quality and completeness of site monitoring reports, central monitoring documentation, and related correspondence to ensure accuracy and consistency.
- Identify and document risks, protocol deviations, and data integrity concerns, escalating critical issues to Clinical Trial Managers or Project Managers as required.
- Ensure timely completion and submission of reviewed deliverables in accordance with study timelines and sponsor requirements.
- Support the evaluation of monitoring report quality, trends, and operational performance, contributing insights for process improvement and action planning.
- Participate in project meetings, training sessions, and ongoing communications to maintain up-to-date knowledge of study progress and requirements.
- Document findings and ensure appropriate tracking of action items within relevant clinical systems such as CTMS.
- Experience in clinical research, clinical operations, or a related life sciences role, preferably within a CRO or pharmaceutical environment.
- Strong understanding of GCP guidelines, clinical trial processes, and regulatory compliance requirements.
- High attention to detail with strong analytical and documentation skills.
- Ability to identify risks, inconsistencies, and protocol deviations within clinical documentation.
- Strong communication skills with the ability to escalate issues clearly and effectively.
- Proficiency in clinical systems such as CTMS or similar platforms is an advantage.
- Ability to work collaboratively in global, cross-functional teams in a fast-paced environment.
- Degree in life sciences, pharmacy, nursing, or a related discipline preferred.
- Competitive compensation aligned with industry standards.
- Comprehensive medical insurance coverage as per company policy.
- Opportunities for continuous learning, training, and career development in clinical research.
- Exposure to global clinical trials and leading pharmaceutical development programs.
- Flexible and remote-friendly work arrangements depending on project requirements.
- Structured career progression within a global life sciences organization.
- Inclusive and collaborative work environment focused on innovation and patient impact.