Clinical Data Coder (Bulgaria)

Description

The Clinical Data Coder is primarily responsible for providing support to activities related to coding of Clinical data for ongoing clinical studies. The Clinical Data Coder will also participate in various clinical data management activities required to ensure that data captured are collected, managed and reported clearly, accurately and securely. In addition, this position is required to conduct all these activities in conformance with applicable regulatory requirements, industry guidelines, and Innovaderm standard operating procedures (SOPs) while respecting Innovaderm’s commitment to sponsor’s requirements and timelines.

More specifically, the Clinical Data Coder must:

• Perform accurate coding of medical terms and medications utilizing industry-wide standards (MedDRA, WHO Drug) as well as company standards;
• Coordinate the assignment of appropriate dictionaries for meeting study requirements;
• Develop and maintain coding guidelines;
• Review and provide input to the Coding section of the Data Management Plan;
• Perform the Dictionary up-versioning activities and Synonym List upgrade;
• Validate/test the coding set up and programming of coding reports; may also test databases, edit specifications or any related programming activities;
• Conduct data review.
• Write and resolve data clarifications.
•  Understand and comply with core operating procedures and work instructions.
• Perform other duties as directed by the Lead Data Manager.
• Meet objectives as assigned.
• Develop and maintain good communications and working relationships with the DM team.

Requirements

• Bachelor’s degree or educational equivalence in pharmacy, life sciences or related field or medical, nursing qualification with 2 years relevant experience or equivalent combination of education, training and experience;
• Thorough knowledge of Medical Terminology;
• Thorough knowledge of Medical Dictionaries used for coding (e.g. MedDRA, WHODD etc.);
• Experience working with clinical trials or within the pharmaceutical environment is preferred;
• Demonstrate understanding and experience in query management process;
• Ability to work flexibly on simultaneous projects and proactively manage time to meet own deadlines;
• Excellent written and verbal English communication skills;
• Ability to work in a global team environment;
• Excellent organizational and analytical skills and high attention to detail;
• Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines.

Our company

The work environment 

At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. 

In this position, you will be eligible for the following perks: 

• Flexible work schedule
• Home-based position
• Ongoing learning and development 

About Indero  

A Global Clinical Leader In Dermatology and Rheumatology!

Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint.

Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery. Our full-service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. With capabilities in North America, Europe, Asia Pacific and Latin America; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal CRO partner for clinical needs at global scale.

Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. 

Indero only accepts applicants who can legally work in Bulgaria.