Job Description

The Clinical Study Report (CSR) Document Specialist is responsible forthe coordination, formatting, quality control, document management, and finalization of Clinical Study Report appendices for assigned studies. This role works closely with TMF Managers, Study Leads, Medical Writers, Biostatisticians, Clinical Operations, Regulatory Affairs, Data Management, and Quality teams to ensure that clinical study documentation is accurate, compliant, submission-ready, and delivered according to project timelines.

The CSR Document Specialist plays a critical role in supporting the preparation and maintenance of clinical documents in compliance with ICH-GCP guidelines, company SOPs, regulatory requirements, and industry standards.

Key Responsibilities

• Coordinate the development, compilation, review, and finalization of Clinical Study Report (CSR) appendices.
• Lead the CSR appendices kick off meeting and define the timelines together with the CSR sub team.
• Format CSR appendices according to company templates, style guides, and regulatory requirements.
• Development of the Financial Disclosure (FD) and BIMO module for submission studies as required.
• Maintain version control throughout the document lifecycle.
• Perform comprehensive quality control (QC) checks on CSR appendices.
• Ensure documents comply with established SOPs, ICH guidelines, and submission standards.
• Support document review workflows and approval processes.
• Verify submission-ready formatting and publishing requirements.
• Coordinate timelines for document development, review cycles, and approvals.
• Monitor project milestones and escalate risks that may impact delivery timelines.
• Support inspection and audit readiness activities.
• Maintain document repositories and archival records.
• Ensure documentation is stored and managed within electronic document management systems (eDMS).
• Follow data integrity and confidentiality requirements.
• Identify and implement the improvements of processes to enhance quality of the TMF documents for relevant CSR appendices
• Contribute to process optimization initiatives.

Education

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, Health Sciences, Biotechnology, Medical Communications, or a related discipline.

Experience

• 2–5 years of experience in:

o Clinical document management

o Medical writing support

o Regulatory operations

o Pharmaceutical, biotechnology, or CRO environments

• Experience supporting Clinical Study Reports and regulatory documentation.

Preferred Qualifications

• Familiarity with ICH E3 Clinical Study Report guidelines.
• Knowledge of Good Clinical Practice (GCP) requirements.
• Experience with electronic document management systems (Veeva Vault, Documentum, SharePoint, or similar).
• Experience supporting regulatory submissions and publishing activities.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is 171.500,00 zł - 318.500,00 zł. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.