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Wednesday, 27 April 2016


PAREXEL International Corporation is a leading global bio/pharmaceutical services organization providing a broad range of knowledge-based contract research





Clinical Data Coder I


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Job Description:
There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

That's PAREXEL. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor
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Essential Function
The role of the Clinical Data Coder I (CDC I) is to perform assigned tasks or activities in clinical data management coding. Activities may include user acceptance testing (UAT), coding, data validation, generation and integration of queries, and running of reports under supervision of senior coder team members and/or line manager. Under direct supervision begins to learn the Principal CDC role.

All tasks should be performed in accordance to corporate quality standards, SOPs/Work Instruction/Guidelines, ICH-GCP and/or other international regulatory requirements.

Relationships

Reports To

Associate Manager or Manager
Directly Supervises N/A
Provides Work Directions to Project Team members as appropriate
Works Closely with All project team members, Quality Management Group (QMG) and Information Services (IT).
External Relationships Sponsors, External or 3rd party Vendors, Auditors and Regulators

Accountabilities:
- Demonstrates competence while performing activities including:
 Coding
§
 May include User Acceptance Testing
§
§ Data validation and cleaning associated to verbatim requiring coding
 Generation and integration of
§ data queries
 Coding
§ data reconciliation tasks
- Support site monitoring personnel to retrieve coding data as required
- Provide work status updates regularly to direct supervisor
- Other assigned responsibilities as needed

Skills
- Good interpersonal, verbal and written communication skills
- Awareness of all relevant regulations, including ICH-GCP, 21 CFR 11
- Knowledge of medical terminology and awareness of coding dictionaries (e.g.MedDRA & WHODrug)
- Ability to work in team environment
- Good analytical skills and attention to detail
- Effective time management to meet daily metrics or team objectives, completion of assigned tasks in a timely manner

Education
- Bachelor's degree and / or other medical qualification or relevant Coding or Data Management experience

Language Skills
- Competent in written and oral English. Excellence in regional languages as needed.

Minimum Work Experience
- Previous relevant coding, data management work experience required; clinical and/ or research experience required. 















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