At least 2–3 years of experience in the medical device, pharmaceutical, or biotechnology industry, emphasizing clinical data coding with standard dictionaries and adverse event reconciliation.
Experience successfully performing and leading data management activities.
Experience with both paper and electronic data capture data collection systems.
Hands-on ability to create case report forms from scratch, develop edit check logic and specifications, perform data review activities, and lead at least one database lock.
A degree in a scientific, medical, or relevant clinical discipline is preferred, such as a Bachelor of Science in Nursing, Registered Nurse, Licensed Practical Nurse, or Physician Assistant qualification; comparable clinical data management accomplishments are acceptable.
Experience designing a case report form from scratch.
Experience with Clinical Data Acquisition Standards Harmonization.
Technical expertise with paper and electronic data capture data collection systems, case report form creation, edit check logic and specifications, data review activities, and database locks.
Experience coding clinical data.
Responsibilities
Own database management activities from study start-up through database lock across multiple global clinical trials.
Ensure quality and compliance standards align with Food and Drug Administration regulations, Good Clinical Data Management Practices, and company standard operating procedures.
Code clinical studies using standard dictionaries such as Medical Dictionary for Regulatory Activities and World Health Organization Drug Dictionary.
Conduct adverse event reconciliation and apply medical terminology and practices.
Create case report forms, build the clinical database, develop edit check logic and specifications, perform data review activities, and lead database locks.
Own data management activities for assigned studies from start-up to database lock across multiple global clinical trials.
Contribute to departmental operational excellence initiatives as a key contributor.
Desired Qualifications
Experience in medical device or pharmaceutical organizations.
Strong clinical coding experience.
Job Description
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.
Qualifications
Additional Information
All your information will be kept confidential according to EEO guidelines.