Clinical Data Coder

Há 3 horas


Rondônia, Brasil Indero Tempo inteiro

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.

Brand name:
Indero



  • Rondônia, Brasil Indero Tempo inteiro

    As a Clinical Data Manager II, you will ensure that data captured in multiple clinical trials undertaken or managed by Indero is collected, managed, and reported clearly, accurately and securely. **This role will be perfect for you if**: - You want to work on studies end-to-end (involved from protocol review to database lock) - You have the experience and...

  • Clinical Operations Lead

    2 semanas atrás


    Rondônia, Brasil Alimentiv Tempo inteiro

    Responsible for the clinical operations of a project within a defined regional/global level. Provides oversight of project deliverables, assigned Clinical Research Associate (CRAs) and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local regulations. The COL acts as a primary liaison...

  • Clinical Operations Lead

    1 semana atrás


    Rondônia, Brasil Alimentiv Tempo inteiro

    Responsible for the clinical operations of a project within a defined regional/global level. Provides oversight of project deliverables, assigned Clinical Research Associate (CRAs) and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local regulations. The COL acts as a primary liaison...

  • Clinical Project Manager

    4 semanas atrás


    Rondônia, Brasil Alimentiv Tempo inteiro

    **Project Management**:- Manage the planning, execution, progress and completion of assigned clinical research projects.- Work with functional experts to ensure all project activities comply with applicable regulations, guidelines, and corporate policies.- Maintain operational, financial and regulatory integrity and safety.- Develop and/or participate in the...

  • Clinical Project Manager

    2 semanas atrás


    Rondônia, Brasil Alimentiv Tempo inteiro

    **Project Management**: - Manage the planning, execution, progress and completion of assigned clinical research projects. - Work with functional experts to ensure all project activities comply with applicable regulations, guidelines, and corporate policies. - Maintain operational, financial and regulatory integrity and safety. - Develop and/or participate...

  • Clinical Project Manager

    1 semana atrás


    Rondônia, Brasil Alimentiv Tempo inteiro

    **Project Management**:- Manage the planning, execution, progress and completion of assigned clinical research projects.- Work with functional experts to ensure all project activities comply with applicable regulations, guidelines, and corporate policies.- Maintain operational, financial and regulatory integrity and safety.- Develop and/or participate in the...

  • Clinical Project Manager

    1 semana atrás


    Rondônia, Brasil Alimentiv Tempo inteiro

    **Project Management**: - Manage the planning, execution, progress and completion of assigned clinical research projects. - Work with functional experts to ensure all project activities comply with applicable regulations, guidelines, and corporate policies. - Maintain operational, financial and regulatory integrity and safety. - Develop and/or participate...


  • Rondônia, Brasil Alimentiv Tempo inteiro

    Manage, deliver and/or perform full clinical site monitoring services for one or more projects, which may include multiple services, be complex in nature and/or run on a multinational scale. In-house based position, responsible for the design and oversight of project monitoring services including training, site/patient recruitment, site data/document...


  • Rondônia, Brasil Alimentiv Tempo inteiro

    Primarily a training and development role, this position will support and observe clinical site monitoring services both inhouse and in the field whilst developing CRA skills and knowledge. This role will have exposure and training in all aspects of the clinical site monitoring services whilst providing monitoring and site management activities for...

  • Data Analyst Ii

    2 semanas atrás


    Rondônia, Brasil Signant Health Tempo inteiro

    Are you ready for the Most Impactful Work of Your Life? Signant Health is a global evidence-generation company. We’re helping our customers digitally enable their clinical trial programs, meeting patients where they are, driving change through technology and innovations, and reimagining the path to proof. Working at Signant Health puts you in the very...