Opening for Clinical Coder II @ INC Research Gurgaon
INC Research is a top-tier therapeutically focused global clinical research organization (CRO) providing a complete range of Phase I – Phase IV clinical development services for the world’s biopharmaceutical companies. We proudly boast 43 of the world’s top 50 pharmaceutical companies as our customers. With approximately 5,000 employees across six continents and experience spanning more than 100 countries, we provide significant scale, scope and expertise to deliver innovative clinical development approaches and strategic alliances that meet the needs of our customers.
We are looking to hire a Clincal Coder II to join our Biometrics team.
Responsibilities:
1. Functions as the Lead Coder on multiple projects.
2. Responsible for coding of clinical and/or safety data and ensures coding consistency, uniformity, and clarity across all pertinent data. Verifies with relevant authorities that sponsors’ license requirements are met.
3. Researches and resolves coding-related questions. Creates queries and/or notifies relevant parties as to coding discrepancies. Functions as the Project Lead on coding-only studies including legacy recoding projects.
4. Participates in audits and bid defense meetings.
5. Attends QuickStart Camp and identifies coding requirements for sponsors.
6. Develops project-specific coding guidelines incorporating best coding practices and sponsor-specific guidelines.
7. Identifies and refers reported terms that are not able to be coded per coding guidelines to Lead Data Manager/Drug Safety Manager for further disposition.
8. Participates in ongoing review of auto-coded and interactively coded clinical/safety trial data for accuracy and overall consistency.
9. Collaborates with Lead Data Manager/Drug Safety Manager to track and resolve outstanding coding queries/considerations.
10. Generates study-specific clinical coding reports (data and/or safety) on a regular basis to maintain high-quality coding.
11. Obtains sign-off and approval of the clinical coding report from the sponsor according to study timelines.
12. Shares coding expertise in meetings with all relevant parties including sponsors, as required.
Qualifications:
Bachelor Degree in the biological sciences or related disciplines in the natural science/health care field.
Nominal, directly related data management experience or equivalent combination of education and experience.
Experience in assigning MedDRA, WHO Drug, and ATC codes to clinical/safety data. Working knowledge of ICH/Good Clinical Practices.
Ability to multitask under deadlines and work as part of a multi-disciplinary team as well as independently.
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract.
Occasionally required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
Why choose us:
It takes skill and passion to develop medicines the way we do. Don’t worry – if you’ve got the passion part, we’ll help you develop the skills you need to enhance every aspect of your career in the clinical research industry.
We’ve got an attitude at INC: “Can do, I own it.” Absolutely everyone has ownership of what they do here. And because we’re given the freedom and responsibility to really own our projects, we can take them to new levels. And that means we can take our careers wherever we want them, too.
“We were ranked “Top CRO” to work with in the CenterWatch 2013 Investigative Site Relationship Survey (a biannual survey of over 2,000 sites worldwide).”
What happens next:
If your application is successful you will be contacted by one of our dedicated recruiters who will arrange a suitable date and time to speak to you further about this opportunity.
Click here to apply
INC Research is a top-tier therapeutically focused global clinical research organization (CRO) providing a complete range of Phase I – Phase IV clinical development services for the world’s biopharmaceutical companies. We proudly boast 43 of the world’s top 50 pharmaceutical companies as our customers. With approximately 5,000 employees across six continents and experience spanning more than 100 countries, we provide significant scale, scope and expertise to deliver innovative clinical development approaches and strategic alliances that meet the needs of our customers.
We are looking to hire a Clincal Coder II to join our Biometrics team.
Responsibilities:
1. Functions as the Lead Coder on multiple projects.
2. Responsible for coding of clinical and/or safety data and ensures coding consistency, uniformity, and clarity across all pertinent data. Verifies with relevant authorities that sponsors’ license requirements are met.
3. Researches and resolves coding-related questions. Creates queries and/or notifies relevant parties as to coding discrepancies. Functions as the Project Lead on coding-only studies including legacy recoding projects.
4. Participates in audits and bid defense meetings.
5. Attends QuickStart Camp and identifies coding requirements for sponsors.
6. Develops project-specific coding guidelines incorporating best coding practices and sponsor-specific guidelines.
7. Identifies and refers reported terms that are not able to be coded per coding guidelines to Lead Data Manager/Drug Safety Manager for further disposition.
8. Participates in ongoing review of auto-coded and interactively coded clinical/safety trial data for accuracy and overall consistency.
9. Collaborates with Lead Data Manager/Drug Safety Manager to track and resolve outstanding coding queries/considerations.
10. Generates study-specific clinical coding reports (data and/or safety) on a regular basis to maintain high-quality coding.
11. Obtains sign-off and approval of the clinical coding report from the sponsor according to study timelines.
12. Shares coding expertise in meetings with all relevant parties including sponsors, as required.
Qualifications:
Bachelor Degree in the biological sciences or related disciplines in the natural science/health care field.
Nominal, directly related data management experience or equivalent combination of education and experience.
Experience in assigning MedDRA, WHO Drug, and ATC codes to clinical/safety data. Working knowledge of ICH/Good Clinical Practices.
Ability to multitask under deadlines and work as part of a multi-disciplinary team as well as independently.
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract.
Occasionally required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
Why choose us:
It takes skill and passion to develop medicines the way we do. Don’t worry – if you’ve got the passion part, we’ll help you develop the skills you need to enhance every aspect of your career in the clinical research industry.
We’ve got an attitude at INC: “Can do, I own it.” Absolutely everyone has ownership of what they do here. And because we’re given the freedom and responsibility to really own our projects, we can take them to new levels. And that means we can take our careers wherever we want them, too.
“We were ranked “Top CRO” to work with in the CenterWatch 2013 Investigative Site Relationship Survey (a biannual survey of over 2,000 sites worldwide).”
What happens next:
If your application is successful you will be contacted by one of our dedicated recruiters who will arrange a suitable date and time to speak to you further about this opportunity.
Click here to apply
0 comments:
Post a Comment