Pharmaceutical Jobs - Clinical Research Jobs

Position

Clinical Coder II x 2 - Battle-UK

Company

INC Research

Location

Battle

Country

United Kingdom

Job Description

Clinical Coder II x 2 - Battle-UK

Responsible for coding of adverse events, medical history, medications, and any other pertinent findings reported within the clinical study as contractually obligated. Mentors and trains less experienced staff, may function as Lead Coder.

ESSENTIAL JOB FUNCTIONS:

1. May function as Lead Coder on one or more projects.

2. Responsible for coding 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 and/or notifies relevant parties as to coding discrepancies.

4. Participates in the preparation for audit 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 and/or safety 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 facilitate an ongoing review of the coding.

11. Obtains sign-off and approval of the clinical coding report from the sponsor according to study timelines.

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 the sponsor, and as required.

13. Attends team meetings as the Clinical Coding representative.

14. Reviews and understands study protocols and other related materials. Maintains an overall knowledge of regulatory guidelines, industry standards, and new technologies as they relate to coding requirements.

OTHER DUTIES:

Performs other data services work related duties as assigned. Minimal travel may be required (up to 25%).

EDUCATIONAL/SKILL/EXPERIENCE REQUIREMENTS:

Requires a minimum of a B.S. /B.A. degree in the biological sciences or related disciplines in the natural science/health care field or equivalent plus directly related data management experience or equivalent combination of education and experience that provide the skills and knowledge necessary to perform the job. Experience with Oracle TMS and other database tools and working knowledge of medical terminology, disease states, medical procedures and medications is desired. Experience in assigning MedDRA, WHO Drug, and ATC codes to clinical/safety data and knowledge of coding best practices and philosophy such as MedDRA's Points to Consider is required. Working knowledge of ICH/Good Clinical Practices is required. Requires effective oral and written communication skills, presentation skills, and attention to detail. Experience with relational database management software systems is required. Ability to multitask under deadlines, and work as part of a multi-disciplinary team as well as independently. Requires proficiency in Word, Excel, and Email.

INC Research is pleased to offer our employees a comprehensive benefits plan that includes: Healthcare Coverage (Medical/Dental/Vision), Flexible Spending Accounts, 401(k), Life Insurance and AD&D, Short- and Long-Term Disability, Supplemental Income Protection, Employee Assistance Program, Paid Time Off and Paid Holidays.

We offer a competitive salary and comprehensive benefits package. For immediate consideration, please email your CV with salary requirements to: (Email submissions preferred.)

Company Profile

INC Research is a therapeutically focused global contract research organization (CRO) with unrivaled expertise and a reputation for conducting global clinical development programs of the highest integrity. INC Research has a deep-rooted history of therapeutic expertise and technological innovation. Founded more than two decades ago as an academic research organization focused on CNS research, we've translated that expertise into a global organization with the added specialties of infectious diseases, oncology and pediatrics, as well as full data services capabilities.

Job Type

Full Time

Salary

Upto 0 $ Per Month

Skills Required

Clinical Data Management

Reference

CCII/Battle

Posted On

24 November 2009

Last Date to Apply

25 December 2009

Important Notice

For jobs based in the EU it is unlawful to employ a person who does not have permission to live and work in the EU. Unless the job advert states otherwise, please ensure you have this permission before applying.

Please note and rest assured that your CV and details will be strictly confidential as there is no CV search on our database. By submitting your CV and contact details we will alert you of new jobs and opportunities matching your skills.