Key Facts

Remote From:

Anywhere

Category: Consultant

Freelance

Senior (5-10 years)

English

Hard Skills

Clinical Data Analysis Regulatory Compliance Clinical Quality Management Auditing Cross-Functional Collaboration Clinical Data Management Protocol Analysis Auditing Version Control Clinical Trial Management Systems +6 more

Other Skills

•
Virtual Teams
•
Communication
•
Analytical Skills
•
Teamwork
•
Critical Thinking
•
Detail Oriented
•
Problem Solving

Roles & Responsibilities

Bachelor's degree in Life Sciences, Pharmacy, Nursing, or related field
5+ years of experience in clinical research, QA/QC, or clinical operations
Strong knowledge of FDA regulations, ICH guidelines, and GCP
High attention to detail with strong analytical and problem-solving skills

Requirements:

Perform QC reviews of clinical documents (CSRs, protocols and amendments, ICFs, monitoring visit reports, and TMF documents) to ensure accuracy, quality, and regulatory compliance with FDA, ICH, and GCP standards.
Verify data accuracy and consistency across clinical systems (EDC, CTMS, TMF); identify discrepancies, communicate findings to clinical teams, and support audit/inspection readiness.
Collaborate with cross-functional teams (Clinical Operations, Data Management, Regulatory Affairs); assist in preparation of protocols, CSRs, study-level documentation, and submission materials; edit statistical analysis plans and table/figure/listing specifications for grammar and consistency.
Maintain proper documentation, version control, and audit readiness; support inspection readiness activities and internal audits; participate in the preparation/editing of regulatory submission documents as needed.

MEDVACON LIFE SCIENCES, LLC

Pharmaceuticals

About MEDVACON LIFE SCIENCES, LLC

MEDVACON is a renowned company recognized globally for providing tailored FDA Quality Compliance and Technical Consulting Services. With an unwavering commitment, MEDVACON partners with Life Sciences Companies to achieve optimal solutions while effectively managing compliance-related expenditures. MEDVACON’s extensive array of services reflects our dedication to client satisfaction. Our proficiency encompasses Validation, Qualification, Quality Systems, IT Computer System Validation/Software Quality Assurance (CSV/SQA), FDA Audit Preparation, Response and Remediation Services, as well as Training, Tech Transfers, and Project Management. We look forward to partnering and working with you and your organization! MEDVACON, Elevating Excellence

Company type: SME

Industry: Pharmaceuticals

Founded: 2018

Company size: 51 - 200

Website LinkedIn See all jobs →

Job description

Clinical QC Consultant – Job Description
Position Overview
The Clinical QC Consultant is responsible for ensuring the quality, accuracy, and compliance of clinical trial documentation and data. This role supports clinical operations by performing quality control reviews and ensuring adherence to regulatory requirements and internal standards.

Key Responsibilities

Perform QC review of clinical documents, including:
- Clinical study reports (CSRs)
- Protocols and protocol amendments
- Informed consent forms (ICFs)
- Monitoring visit reports
- Trial master file (TMF) documents
Ensure compliance with:
- Food and Drug Administration (FDA) regulations
- International Council for Harmonisation (ICH) guidelines
- Good Clinical Practice (GCP) standards
Verify data accuracy and consistency across clinical systems (e.g., EDC, CTMS, TMF)
Identify discrepancies, errors, or missing information and communicate findings to clinical teams
Ensure proper documentation, version control, and audit readiness
Support inspection readiness activities and participate in internal audits
Collaborate with cross-functional teams including Clinical Operations, Data Management, and Regulatory Affairs
Assist in the preparation of protocols (including the writing of administrative letters for protocols and summary of changes for protocol amendments) and CSRs.
Assist in the preparation of study-level documentation required for clinical trials (e.g., CSR appendices, shell drafts)
Edit CSR statistical analysis plans and table/figure/listing specifications for grammar, format, and consistency.
Support authoring of protocols, investigator brochures, CSRs and other study-level documentation required for clinical trials.
Edit submission documents (sections of CSRs, IND/CTA, NDA, MAA, requests for information and briefing documents. etc.) for regulatory agencies.
Reviews CSR statistical analysis plans and table/figure/listing specifications for grammar, format, and consistency.

Required Qualifications

Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related field
5+ years of experience in clinical research, QA/QC, or clinical operations
Strong knowledge of FDA regulations, ICH guidelines, and GCP
Experience reviewing clinical trial documentation and TMF management
High attention to detail and strong analytical skills

Preferred Qualifications

Experience in hepatology or rare disease clinical trials (relevant to focus areas)
Prior experience in a biotech or pharmaceutical company
Familiarity with electronic systems such as Veeva Vault, Medidata, or similar

Key Skills

Quality control and audit readiness
Documentation review and compliance
Communication and collaboration
Problem-solving and critical thinking

Work Environment

Contract/consultant role
Remote or hybrid (depending on project needs)
May require collaboration across global teams

Important Notice: Protecting Your Information
Medvacon Talent Acquisition only conducts initial video interviews via Microsoft Teams or Zoom. All communication will come from an email address ending in @medvacon.com. If you receive a message that seems suspicious or is not from our official domain, please report it immediately to jobs@medvacon.com.

Ready to apply?

APPLY

Share ·