Clinical Data Coder (Romania)

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

At Indero, you will work alongside brilliant and driven colleagues. Our core values are integrity, commitment, and teamwork. We offer a stimulating work environment with attractive opportunities for growth and advancement.

As a Project Manager, you will be eligible for the following perks:

• Flexible schedule
• Vacation
• Home-based position
• Ongoing learning and development opportunities

About Indero

Indero is a contract research organization (CRO) specialized in dermatology and rheumatology. Since its founding in 2000, our organization has built a strong reputation for delivering high-quality research and services that exceed client expectations. Based in Montreal, Indero continues to grow and expand across North America and Europe, including operations in Romania.

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

Description - Fr

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Profil recherché

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Notre entreprise

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