Precision for Medicine is seeking a talented Senior Medical Coder to provide comprehensive Coding and related data management support throughout all phases of the clinical trial data management process. With direct supervision work with a team of medical coders and sometimes supervising medical coders as a senior, you will ensure adherence to Standard Operating Procedures (SOPs), regulatory guidelines, and study-specific plans. This role encompasses a range of responsibilities, including data coding and quality review within a dynamic team environment. 

Position Summary: 

The Senior Coder provides Coding in both MedDRA and WHODRUG dictionaries for assigned Studies on a full time basis. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives: study specific plans and guidelines will be followed. This position will perform Coding quality reviews. Working closely with the Coding Manager to ensure priority coding tasks are performed and completed in a timely manner. Working with the Coding manager to focus the medical coders as a senior coder. 

Essential functions of the job include but are not limited to: 

• Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency (MedDRA and WHODRUG) 

• Support other members as a back-up and/or coding team member, ensuring continuity, responsiveness, and that tasks are performed in a timely manner 

• Backup the Coding manager for oversight of the team. 

• Perform quality control of Coding  

• Provide input into Coding timelines for overall deliverables.  

• Ensure that clinical data coding deadlines are met with quality.  

• May assess resource needs for assigned projects, as needed. 

• Review/feedback from all stakeholders 

• Conduct coding dictionary upgrade UAT and maintain quality controlled documentation as needed 

• Responsible for creating, revising, appropriate versioning and maintaining data management coding documentation. 

• Train clinical research personnel on the study specific Coding related items as needed. 

• Review and query coding data according to the Data Management Plan and Coding standards 

• Run coding status and metric reporting. 

• Assist in participating in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to coding activities 

• Trains and ensures that all data management project team members coding have been sufficiently trained. 

• Communicate with study sponsors and project teams as needed regarding coding. 

• Present any coding demonstrations/trainings, department/company training sessions, project meetings 

• Perform other duties as assigned. 

 

Qualifications 

Minimum Required: 

• 5+ years’ experience within Data Management 

• Bachelors within scientific/science background and combination of related experience 

Other Required: 

• 5+ years performing Dictionary medical coding (MedDRA and WHODrug) 

• Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook. 

• Able to handle a variety of data management task and oversight. 

• Excellent organizational and communication skills 

• Professional use of the English language; both written and oral. 

• Basic knowledge of drug, device and/or biologic development and effective data management  

• practices 

Preferred: 

• Experience in a clinical, scientific or healthcare discipline. 

• Oncology and/or Orphan Drug therapeutic experience 

Skills:  

• Demonstrates strong knowledge of ICH-GCP, relevant Precision Oncology SOPs, and regulatory guidance, as well as the ability to implement and drive outcomes  

Competencies: 

• Motivates project team members to meet timelines and project goals  

• Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective  

• Resolves project related problems and prioritizes workload to meet deadlines with minimal support 

• Exhibits a high degree of self-motivation, and can work and plan independently as well as in a team environment  

• Demonstrates an acceptable degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills