Clinical Report Reviewer

3-4 years

Not Disclosed

Chandigarh Mohali

10 May 7, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Technical Skill, Triage of ICSRs, WHO DD Coding

Share your CV - hr@indivirtus.com with CC to admin1@indivirtus.com

Position: Clinical Report Reviewer
Location: Mohali / Chandigarh
Experience: 3-4 years

Summary:

Detail-oriented Clinical Report Reviewer with 3-4 years of experience in reviewing clinical trial documentation. Proficient in ensuring compliance with regulatory requirements and company standards. Seeking to contribute expertise in clinical report review to enhance the quality and accuracy of clinical trial deliverables.

Key Responsibilities:

Reviewing clinical study reports (CSRs), protocols, and related documentation for accuracy, completeness, and compliance with regulatory requirements.
Identifying discrepancies or inconsistencies in clinical data and ensuring timely resolution.
Collaborating with cross-functional teams, including clinical operations, medical writing, and regulatory affairs, to address review findings and ensure data integrity.
Providing feedback and recommendations for improvements to study protocols, data collection forms, and other study documents.
Participating in internal quality assurance activities, including audits and inspections, to ensure adherence to SOPs and regulatory standards.
Contributing to the development and implementation of process improvements to enhance efficiency and quality in clinical report review processes.

Requirements:

Bachelor's degree in life sciences or related field.
3-4 years of experience in clinical research or related field, with specific experience in clinical report review.
Strong understanding of ICH guidelines, GCP, and regulatory requirements for clinical trial documentation.
Excellent attention to detail and ability to identify discrepancies in clinical data.
Proficiency in reviewing and interpreting clinical study protocols and reports.
Effective communication skills and ability to work collaboratively in a cross-functional team environment.
Experience with electronic document management systems and Microsoft Office Suite.

Preferred Qualifications:

Master's degree in life sciences or related field.
Certification in clinical research (e.g., ACRP, SoCRA).
Experience with regulatory submissions (e.g., IND, NDA, MAA).
Familiarity with therapeutic areas relevant to the company's portfolio.
Experience with data visualization tools and techniques.

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Clinical Report Reviewer

Job Description

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