Clinical Data Coder

5 months ago

Remote, India Innovaderm Research Full time

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.

**This role will be perfect for you if**:

- You are an experienced coder that is able to work autonomously and willing to join a Data Management team as the very first Clinical Data Coder
- Quality work is highly important to you and you ensure to produce consistent work at all times.
- You enjoy working in a smaller team where you can share ideas for improvement.

**RESPONSIBILITIES**
- 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**:
**IDEAL PROFILE**

**Education**
- Bachelor’s degree or educational equivalence in pharmacy, life sciences or related field or medical, nursing qualification.

**Experience**
- 2 years relevant experience or equivalent combination of education, training and experience;
- Experience working with clinical trials or within the pharmaceutical environment is preferred.

**Knowledge and skills**
- Thorough knowledge of Medical Terminology;
- Thorough knowledge of Medical Dictionaries used for coding (e.g. MedDRA, WHODD etc.);
- 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 Innovaderm, 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 : you are required to attend meetings with the global team or your manager on a weekly basis in the late evening (estimated : once per week, availability until approximately 9pm). On days where you don't have meetings, you may determine your own working schedule.
- Home-based position : you may be located in your preferred city in India. You are required to have a stable internet connection with appropriate internet speed.
- Ongoing learning and development

**About Innovaderm**

Innovaderm is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Innovaderm continues to grow and expand in North America and Europe.

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

**_
Innovaderm only accepts applicants who can legally work in India._

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