Senior Medical Coder I

CATO SMS and Pharm-Olam, LLC have merged to form Allucent!

Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment. At Allucent, our mission is to help bring new therapies to light. When you work at Allucent, that means rolling up your sleeves and applying your scientific knowledge, clinical expertise, and experience to partnerships with our clients in small and mid-sized biotech companies.

The Senior Medical Coder I (sMCI) coordinates medical coding activities in compliance with study specific guidelines, standard operating procedures, industry standards and regulatory requirements of CATO SMS Data Management. This position controls and monitors other Data Management (DM) activities from database design & set-up, through cleaning and reporting to database locking, and also contributes to process improvements, and staff learning & development. The sMCI is a member of the Data Management staff.

Data Management

• To include/ adapt as per area specific requirements:

• Collaborates with Clinical programming group in coder implementation and up-versioning of dictionaries
• Provide coding input on electronic Case Report Forms (eCRF) design
• Identify requirements for capturing and processing of clinical data coding ensuring accuracy, consistency, and completeness
• Develop and/or review Coding Guidelines
• Perform clinical data coding using MedDRA and WHODrug medical dictionaries for information contained in eCRF such as adverse event, medical history, pre-existing conditions, and concomitant medications
• Provide listings of coded terms for medical review
• Perform a comprehensive review of all reported and coded terms in collaboration with Medical Monitors and/or Medical Coder reviewers
• Manages queries related to coding terms, through closure, including entering queries into the EDC
• Provides status updates to the lead CDM on study specific coding completion and/or review
• Participates in eCRF review impacted by coding needs.
• Supports Clinical Data Managers in coding related tasks to ensure cleanliness and completion
• Contributes to DM coding strategies, guidelines, and conventions
• Contributes to the development of training manuals, coding conventions
• Train other DM team members in MedDRA, WHO Drug coding practices and assist other team members to resolve complex coding issues.
• May assist DM with SAE reconciliation activities as needed.
• Produces Coding Metric reports to provide to internal/external project team.
• Assists other data reviews using coded data for Biostatistics, Medical Monitor, and sponsor
• Assist and support data management activities
• Provide support on clinical study database set-up, including eCRF design and database validation requirements
• Review and validate clinical data to ensure consistency, accuracy, integrity, and completeness
• Provide support on database lock and close-out processes and procedures
• Participate in conference calls and/or meetings with project team members, vendors, and sponsors
• Maintain documentation on an ongoing basis and ensure that all filing is up to date
• Explore and propose initiatives for improving efficiency
• Knows current regulations and guidances that pertain to medical coding of studies
• Verify that sponsors have the valid medical dictionary licenses for MedDRA and WhODrug and verify that they do on and during the duration of the study
• Provide leadership, guidance and support to other department members.
• Participate in the interview process for new recruits
• Contribute to other areas of CATO SMS business as required

Management, Learning & Development

• Actively support to staff learning & development within the company

Quality Management

• Draft and contribute as Subject Matter Expert (SME) in the field of Senior Medical Coder I activities to the evaluation/improvement of processes and procedures within the Quality Management System

Account Management, Sales & Acquisition

• Assure good communication and relationships with (future) clients
• Contribute and take part in client evaluations, visits and bid defenses

Others

• Contribute to other areas of business as required

Requirements

Qualifications

• Life science, healthcare and/or business degree <