Position Responsibilities/Accountabilities:
- 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
Managerial Requirements/ Responsibilities: N/A
Position Qualifications/Requirements:
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.
- Strong organizational, problem-solving, and analytical skills.
- Versatility, flexibility, and a willingness to work within constantly changing priorities.
- Commitment to excellence and high standards.