Sr. Medical Data Specialist

ArtechInformationSystemLLC

Woodcliff Lake, NJ, United States contract

Posted: December 8, 2015

Job Description

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.

Job Description:

• Must have at least 5 years of both coding and clinical data review experience who can support one of our submissions. Responsible for the selection and review of appropriate codes of reported terms in clinical trials not limited to adverse events, medical history and medications.

• Ensures that the term is clear, appropriate and complete as per investigator s entry on the CRF otherwise, he/she is responsible for the coding query.

• Abstracts all necessary information from other CRF pages for concept coding if necessary. Assigns codes using MedDRA and WHODD terminologies, which most accurately describe each panel according to established coding guidelines and conventions. Performs reconciliation of safety report and clinical patient profile. Post queries for relevant information from safety report to be added in the clinical database. May require narrative writing for clinical data review profile.

• Quantitative analysis Performs a comprehensive review for the all the reported and coded terms. To assure the presence of all coding targets not limited to LLT, PT and SOC and Trade name , Preferred Name ATC 2 and ATC 4 and their respective dictionary versions. Completes brief description of clinical cases for clinical data review utilizing the autogenerated narratives.

• Qualitative analysis- Evaluates the record for coding consistency and adequacy. Ensures that the selected codes accurately reflect the term as provided by the investigator. Reviews the codes for ICH compliance and adherence to coding guidelines and conventions.

• Ensures all safety reports are reconciled in the clinical database. Performs all duties according to company policy and regulations and guidance. Performs other duties assigned by the Director or Sr. Manager. No travel required.

Qualifications:

Graduate of adequate health care related course with commensurate experience in use of dictionaries in Clinical trial setting and have performed clinical data review.

Minimum of 5 years coding experience required as well as AE/SAE data review.

Strong knowledge of ICH guideline, or adequate background and have attended seminars for MEdDRA and WHODD use

Knowledge of Central coding, Ds Navigator , INFORM a plus - Proficiency on all related regulations, GCP, and Good Clinical DM Practice

Computer proficiency and knowledge of medical terminology - Expertise on use of Excel - Strong oral and written communication skills

Sneha Shrivastava

Technical Recruiter (Clinical/Scientific)

Artech Information Systems LLC

360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960

Office: 973.967.3348 | Fax: 973.998.2599

Connect with us on - LinkedIn | Facebook | Twitter

Why Apply Through MisuJob?

AI-Powered Job Matching: MisuJob uses advanced artificial intelligence to analyze your skills, experience, and career goals. Our matching algorithm compares your profile against thousands of job requirements to find positions where you have the highest chance of success. This saves you hours of manual job searching and ensures you only see relevant opportunities.

One-Click Applications: Once you create your profile, applying to jobs is effortless. Your resume and cover letter are automatically tailored to highlight the most relevant experience for each position. You can apply to multiple jobs in minutes, not hours.

Career Intelligence: Beyond job matching, MisuJob provides valuable career insights. See how your skills compare to market demands, identify skill gaps to address, and understand salary benchmarks for your experience level. Make data-driven decisions about your career path.

Frequently Asked Questions

How do I apply for this position?

Click the "Register to Apply" button above to create a free MisuJob account. Once registered, you can apply with one click and track your application status in your dashboard.

Is MisuJob free for job seekers?

Yes, MisuJob is completely free for job seekers. Create your profile, get matched with jobs, and apply without any cost. We help you find your dream job without any hidden fees.

How does AI matching work?

Our AI analyzes your resume, skills, and experience to understand your professional profile. It then compares this against job requirements using natural language processing to calculate a match percentage. Higher matches mean better fit for the role.

Can I apply to jobs in other countries?

Absolutely. MisuJob features jobs from companies worldwide, including remote positions. Filter by location or look for remote opportunities to find jobs that match your preferences.

Ready to Apply?

Join thousands of job seekers using MisuJob's AI to find and apply to their dream jobs automatically.