Lead Medical Coder

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.

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Expected salary

Location

Firenze

Job date

Thu, 08 May 2025 00:42:26 GMT

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