Report Reviewer

This is a fully remote position, open to applicants in India.

📋 Description

• Perform Central Report Review activities on studies in alignment with the monitoring strategy, prioritizing patient safety, compliance with protocols/GCP/regulatory standards, and data integrity.

• Assist in the creation of annotated visit reports, including PSV, SIV, IMV, COV, and SCAN.

• Evaluate the content and quality of site and central monitoring documentation, encompassing site monitoring calls, site visit reports, site letters, central monitoring reports, and relevant correspondence.

• Record requested revisions and approvals in the CTMS, ensuring that deliverables align with company and/or sponsor specifications and deadlines.

• Analyze factors impacting subject/patient safety and clinical data integrity, such as protocol deviations, violations, sponsor requirements, and pharmacovigilance concerns.

• Promptly communicate or escalate serious issues to the Clinical Trial Manager or Project Manager.

• Document review observations and report protocol deviations or action items in the appropriate systems.

• Evaluate CRA/CM report quality, risks, trends, and operational performance, and compile findings for CTM review and action planning.

• Engage in clinical monitoring/project staff meetings and clinical training sessions.

• Keep abreast of current project status through discussions and email correspondence.

• Assist CTM activities, including managing Protocol Deviations and Action Items.

⛳️ Requirements

• Bachelor’s degree or RN in a relevant field, or an equivalent combination of education, training, and experience.

• Ability to thrive in an international environment.

• Prior clinical trial experience in site management and clinical roles is preferred.

• Experience in study management, such as Lead CRA or similar roles, is preferred.

• Familiarity with Good Clinical Practice/ICH Guidelines and other applicable regulatory standards.

• Strong documentation skills and habits.

• Excellent attention to detail.

• Proficient computer skills and a willingness to learn new technologies.

• Effective communication and interpersonal skills with project teams and site personnel.

• Strong critical thinking and problem-solving abilities.

• Knowledge of protocols, SOPs, ICH GCP, and relevant country regulations.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and involved line management.

• Training in technical and therapeutic areas.

• Recognition from peers.

• Comprehensive total rewards program.

• An inclusive organizational culture.

• Reasonable accommodations for candidates with disabilities, when applicable.