Medical Coder (Work from Home)

Department - Data Management and Statistics Department

Role & responsibilities

− Supports the departmental coordination of activities through maintaining relevant project management tools

− Prepares study coding reports − Prepares training material on medical coding activities for internal and external use

− Performs MedDRA coding as requested by the data management responsible of each study − Raises queries in the eCRF or other agreed platforms regarding coding, when required

− Collaborates closely with the study data manager, clinical scientist, the programming team and colleagues from the Pharmacovigilance department to ensure that coding frequency and specifications are commonly approved

− Understands and evaluates comments towards or by the Clinical Science department or by the sponsor on the coded terms and proceed with the respective actions to finalise the coding activities

− Keeps track of performance metrics and informs the study team on the remaining backlog or other potential challenges regarding coding, during the conduct of the study − Conducts on-the-job training for new hires

− Ensures adherence to available tools

− Conducts periodic meetings within the Data Management and Statistics department to promote best practices

− Complies with the Companys Integrated Management System and applicable national and international legislation

Preferred candidate profile

− Required: Proven experience as a data manager, or minimum 3-year proven collaboration with the data management department within a clinical trial, to ensure understanding of the use of technical tools, eCRFs and the queries process

− Desirable:

• Proven experience of medical coding, terminology, and relevant operational activities within the pharma industry
• Experience working with Medidata Rave, Inform and other electronic data capture tools
• Working experience in any programming language or any other data management software
• Experience of working with data management activities, database development, conduct, close out activities.

Key competencies

− Excellent knowledge of ICH/GCP, 21 CFR Part 11 guidelines and regulations, particularly those relevant to clinical data management.

− Good record keeping skills.

− Excellent decision-making and problem-solving skills

− Excellent MS Office command

− Ability and willingness to operate independently.

− Ability to communicate effectively both verbally and in writing.

− Ability to effectively collaborate with data management and cross functional teams.

− Demonstrate a quality driven mindset while performing any of the assigned tasks.

− Ability to work according to specific SOPs, guidelines, regulations & ethical principles in the daily practice