01Overview
The Clinical Programmer is a key member of the Development Operations, Data Management Team. A Clinical Programmer is responsible for program standard and study specific electronic Case Report Forms (eCRFs), edit checks and reports in accordance with approved Database Specifications, Data Management Plans (DMP), Data Transfer Specifications (DTS) and Data Review Specifications (DRS). Set-up study specific mapping for WHO-Drug and MedDRA dictionaries. Provide clinical programming support for data cleaning in clinical trials based on Standard Operating Procedures (SOPs) or study specific guidelines.
Role & responsibilities
Support the clinical programming lead on project teams, and serve as
lead programming lead, as needed.
Program standard and study specific electronic Case Report Forms
(eCRFs), edit checks and reports.
Set-up study specific mapping for WHO-Drug and MedDRA
dictionaries.
Ensure the efficiency, quality, and integrity of database development,
reporting and project activities.
Perform data checks as needed to ensure integrity and correctness
of data displays and to understand structure and content of data.
- Perform QC/validation of vendor datasets, clinical data listings and
edit checks to verify the output.
- Perform other duties as assigned.
- Interact across operational areas as required.
- Interact with sponsor representatives as required.
Education: A 4-year computer science/math degree or equivalent. Experience:
- A minimum of 2 years of relevant work experience, including programming experience with Clinical Database Management Systems, i.e., Medidata Rave, Medrio, IBM, etc.; SAS programming experience also preferred. Previous experience in pharmaceutical research or a CRO setting preferred.
A satisfactory combination of education and experience may be
accepted as a substitute for the specific education and experience
listed above.
Required Certifications: N/A
Required Skills:
Excellent verbal, written, and interpersonal skills.
Knowledge of clinical trial study design.
Able to work on multiple, concurrent projects.
A high degree of accuracy and attention to detail.
Can attend study team meetings as needed.
Ability to travel for meetings or training activities may be required.
Solid organizational, problem-solving, and analytical skills.
Versatility, flexibility, and a willingness to work within constantly
changing priorities.
Commitment to excellence and high standards. .
