The Manager of Medical coding 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 their Coding Team to ensure priority coding tasks are performed and completed in a timely manner. Responsible for coordinating multiple coding deliveries
Essential functions of the job include but are not limited to:
- Lead the coding team to perform coding tasks according to defined priorities, monitor and evaluate coding progress.
- Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency (MedDRA and WHODRUG)
- Support and ensure other members act as a back-up and/or coding team member, ensuring continuity, responsiveness ,and that tasks are performed in a timely manner
- Perform quality control of Coding
- Ensure Coding timelines are in place 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
- Coordinate and 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:
- 8+ years experience within Data Management
- Bachelors within scientific/science background and combination of related experience
Other Required:
- 4+ 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
