CODING SPECIALIST / CLINICAL DATA MANAGER

CODING SPECIALIST / CLINICAL DATA MANAGER 

Houston, TX 

Healthcare

Exp 2-5 yrs

Deg

Relo

Bonus

Visa Candidates welcome

Job Description

Our Coding Specialist / Clinical Data Manager will own our database management activities from start-up to database lock, across multiple global clinical trials while ensuring quality and compliance standards are aligned with FDA regulations, Good Clinical Data Management Practices, and Cyberonics standard operating procedures.

Cyberonics is a mid-size, innovative, medical device company that is seeking a Clinical Coding/ Data Manager to help be a driving force; enabling them to reach their paramount goals! You will have the opportunity to use your clinical coding experience alongside your data management experience to lead the charge for Biostatistics and Clinical Informatics in a small cross-functional team with high visibility, contributing in all facets of the data management; elevating your career rapidly.

Here is what year one will look like:

Code clinical studies for our highly innovative class III medical device designed for treatment resistant epilepsy, in our portfolio using standard dictionaries, conduct adverse event reconciliation, and understand medical terminology and practices.

Create case report forms from scratch, build the clinical database, develop edit check logic and specifications, perform data review activities, and lead database locks.

Own our data management activities for your assigned studies from start-up to database lock, across multiple global clinical trials while ensuring quality and compliance standards are aligned with FDA regulations, Good Clinical Data Management Practices, and Cyberonics standard operating procedures.

Most importantly; you will contribute to departmental operational excellence initiatives as a key contributor.

Reporting directly to the Senior Manager of Clinical Informatics, the Coding Specialist / Clinical Data Manager must be able to work quickly and very accurately with keen attention to detail in order to accomplish the data management strategy.

Have at least 2-3 years’ experience in the medical device, pharmaceutical, or biotech industry with emphasis in coding clinical data with standard dictionaries (e.g., MedDRA, WHO-DD) and performing adverse event reconciliation.

Successfully performed and lead data management activities.

Both paper and EDC data collection systems experience.

Hands-on understanding on how to create case report forms (CRF) from scratch, developing edit check logic and specifications, performing data review activities, and having led the lock of at least 1 database.

Realistically we need qualified healthcare professionals degreed in a scientific, medical, or relevant clinical discipline (BSN, RN, LPN, PA, etc. preferred), but comparable accomplishments in clinical data management is ok too.

SCREENING QUESTIONS

Have you successfully designed a case report from scratch?

Have you worked with CDASH?

Do you have technical expertise with both paper and EDC data collection systems, experience in creating case report forms, developing edit check logic and specifications, performing data review activities, and having led the lock of at least 3 databases

Do you have experience with coding clinical data?

IDEAL CANDIDATE

Medical device experience or pharma. Strong coding experience.