Lead Medical Coder
Pubblicato il 28-08-2026 - MENARINI Group in Firenze
Overview: The Lead Medical Coder will join the Data Management department of the R&D; organization of the Menarini Group. He/She will report to Global DM Manager. The Lead Medical Coderis a critical role responsible for the strategic leadership and execution of medical coding activities for oncology-focused clinical trials and programs. This position ensures the delivery of timely, accurate, and high-quality coded data, adhering to industry standards and regulatory requirements, in daily collaboration with the study data manger leads. The Lead Medical Coder develops and implements a comprehensive coding work-flow to maintain homogeneity across studies and programs, as well he/she will have an operative role in the activity. Main Activities & Responsibilities: - **Leadership and Strategic Direction**:
- Leads clinical trial coding deliverables and activities, providing guidance and mentorship to coding team members.
- Develops and implements a long-term coding strategy specific to oncology trials, ensuring alignment with program goals and regulatory requirements.
- Provides coding expertise and capability in support of global oncology development programs.
- Demonstrated ability to think strategically across the organization, anticipating and addressing challenges in the oncology space.
- ** Coding Execution and Quality Control**:
- Oversee the coding of clinical trial data, including adverse events (AEs), serious adverse events (SAEs), concomitant medications, and other relevant medical data, with a strong emphasis on oncology-specific terminology.
- In case of outsourced activities, reviews study-level coded data performed by vendors for quality, consistency, and adherence to established coding conventions.
- Develops and maintains coding conventions and guidelines to ensure consistency across oncology studies and programs.
- Open and manage queries to site staff into the eCRF in case of non-clear terminology or posology within the data.
- ** Collaboration and Communication**:
- Partners with the data management study leads to optimize workflows, particularly in the context of oncology data management and dictionary maintenance.
- Collaborates with the clinical development team, including medical and scientific personnel, to address uncertainties and ensure accurate coding of oncology-related data.
- Maintains open and effective communication with internal and external stakeholders, including vendors and clinical trial sites.
- Collaborate with clinical development team on uncertainties.
- ** Dictionary Management and Technology**:
- Develops and maintains dictionary management processes, including synonym lists, with a focus on oncology-specific terms and concepts.
- Demonstrates expertise in the utilization of medical dictionaries, specifically MedDRA and WHODrug, with advanced knowledge of oncology-related terminology within these dictionaries.
- Experience with Clinical trial data systems and/or EDC coding tools is required with Medidata Coder experience preferred.
- Partners with the data management team to optimize technology that supports efficient dictionary management processes. Job Requirements:
**Education/Experience**: - Degree with related health science background (e.g.,
biology, pharmacy, nursing).
- May require certification in assigned area (e.g., Certified Clinical Coder (CCC), Certified Professional Coder (CPC)). **Experience/The Ideal for Successful Entry into Job**: - 5+ years of experience in medical dictionary coding within the pharmaceutical, biotechnology, or CRO industry, with a strong emphasis on oncology.
- 3+ years of related experience and/or combination of experience and education/training.
- Advanced knowledge of ICH-GCP guidelines and applicable drug development regulations, particularly in the context of oncology clinical trials.
- Strong understanding of drug development and clinical trial execution, including other required functional areas involved in clinical trials, with a specialized understanding of oncology trial design and execution. **Knowledge/Skills**: - Must have a strong understanding and utilization of medical terminology, with a specialized knowledge of oncology-related terms and concepts.
- Extensive experience in coding medical data (adverse events and concomitant medications) and a deep understanding of the clinical coding process, especially in oncology.
- Expert working knowledge of MedDRA and WHODrug, with the ability to navigate and utilize these dictionaries effectively for oncology data.
- Experience in developing and maintaining dictionary management processes and synonym lists, with a focus on oncology-specific terminology.
- Experience with Clinical trial data systems and/or EDC coding tools is required with Medidata Coder experience preferred.
- Ability to prioritize and multi-task successfully in a fast-paced and changing environment, with the ability to manage multiple oncology trials simultaneously.
- Excellent interpersonal and co