Medvacon Life Sciences

Role Description 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. - 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 and CSRs - 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 for regulatory agencies - Review CSR statistical analysis plans and table/figure/listing specifications for grammar, format, and consistency 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 Requirements - 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.

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description This is a 1099 contract opportunity with no benefits. This is a remote role, but candidates on PST are preferred. We are seeking a highly organized and detail-oriented professional to support the VP, Product Development and the broader team. This role will own a range of coordination, document management, tracking, and follow-up responsibilities that are essential to day-to-day operations, helping ensure work stays organized and on track while senior team members remain focused on core priorities. Responsibilities - Manage document organization, filing, and record maintenance across product development activities. - Support document review workflows, version tracking, and follow up on outstanding items. - Maintain trackers, logs, and status reports for key projects, deliverables, and action items. - Assist with data entry, data trending, and preparation of routine reports and summaries. - Help organize and maintain documentation related to ongoing clinical trial activities. - Support review of records for completeness, accuracy, and consistency. - Coordinate meeting materials, notes, and follow up items. - Work with internal teams and external partners to keep tasks and documentation moving on schedule. - Provide support related to clinical trial supply, including tracking information, organizing records, and helping manage timelines. - Handle a variety of administrative and operational tasks that support the Product Development function. Qualifications - Bachelor’s degree or relevant experience in life sciences, biotechnology, pharmaceuticals, healthcare, business operations, or a related field. - Experience in a coordination, operations, administrative, or support role in a professional environment. - Strong organizational skills and attention to detail. - Ability to manage multiple priorities and follow through consistently. - Comfort working with documents, trackers, and detailed information. - Strong Microsoft Office skills, including Excel, Word, and PowerPoint. - Strong written and verbal communication skills. - Ability to work independently and maintain a high level of accuracy. Preferred Qualifications - Experience in biotech, pharmaceutical, clinical, or product development environments. - Experience supporting document management and cross-functional coordination. - Experience with clinical trial documentation or supply related coordination. 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.