Project Clinical Programmer
posted: July 1, 2021
Emanate Life Sciences is looking for a Project Clinical Programmer
Position Location: Santa Cruz, California; Remote
Salary Range: 100k - 120k
Position Type: Full Time; Exempt
The Project Clinical Programmer provides our clients technical expertise supporting clinical data management.
This role is responsible for the set-up, deployment, and maintenance of software technologies such as EDC, Coding, IxRS, and RSTUDIO. Additionally, the role is responsible for programming study metrics and clinical data listings per the study team’s request.
A successful Project Clinical Programmer leverages interpersonal skills and extensive clinical trials experience to mentor clients on clinical data management practices.
Role and Responsibilities
- Manage the assignment of tasks to team members responsible for programming
- Use project management tools to adhere to timelines
- Organize meetings to discuss project goals and progress
- Complete and delegate tasks to appropriate team members
- Responsible for managing software releases and reporting software issues to the EDC vendor
- Program electronic case report forms (eCRF's) and edit checks within an EDC system
- Ensure validation procedures are followed and maintain appropriate documentation
- Provide data extractions to biostatistician for scheduled analyses (e.g., DSMB, Publications, Annual Reporting)
- Responsible for data integrations
- Organize and manage data science codebase as applicable
- Manage others' contributions to the codebase.
- Independently write programs in the appropriate language (e.g., SAS, R, SQL, Python) to develop data (sets) from multiple databases needed to support deliverables
- Ability to write, modify, and debug code
- Responsible for programming data visualizations
- Develops programs for organizing data to analyze, identify and report trends
Acts independently to determine methods and procedures on tasks and projects.
Other duties as assigned.
Bachelor's degree (or international equivalent) in computer science, mathematics, Life Sciences, or other appropriate disciplines and eight years of related experience.
- Minimum of five years of recent clinical programming experience designing studies and data validation programming in EDC.
- At least eight years of clinical programming experience within the medical device, pharmaceutical, or CRO environment
- Knowledgeable in GCP, CDISC standards, clinical trial guidelines & Data Management Best Practices.
- Applied knowledge of Medidata suite of applications (e.g., Medidata Coder, CTMS, Medidata Imaging, Lab Administration Module) a plus.
- Experience with programming languages, such as PL/SQL, SAS, C#, or VB preferred.
- Excellent verbal/written and interpersonal skills required for working successfully in a cross-functional team environment.
- Communicate and collaborate effectively with cross-functional teams in face-to-face conversation, by telephone, and by email.
- Exercise professional judgment to implement new process and complete assignment