Job title:
Lead Medical Coder
Company:
Menarini Group
Job description
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.
- Serves as a medical coding subject matter expert, particularly in oncology terminology and coding practices.
- 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 communication skills, both written and oral, including the ability to develop strong relationships with internal and external stakeholders, including oncology specialists and researchers.
- Excellent organizational skills with strong attention to detail; proven ability to handle multiple tasks efficiently, effectively, and timely, especially in the context of complex oncology data.
- Self-motivated, calm under pressure, and adaptable to a dynamic environment, with the ability to support successful change in the rapidly evolving field of oncology.
- Problem-solving skills should involve identification of problems and proper escalation, with a focus on resolving complex coding issues related to oncology.
- Must be fluent speaking and writing in English.
- Must be able to work independently as well as in a team environment and effectively collaborate with stakeholders for effective outcomes, specifically in the context of oncology research and development.
#LI-DNI
Expected salary
Location
Firenze
Job date
Thu, 08 May 2025 00:42:26 GMT
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