Clinical Data Specialist

3 days ago


Hyderabad, Telangana, India Imaging Endpoints Full time
Company Overview
Imaging Endpoints is an imaging technology and clinical research organization passionately focused on connecting imaging to the cure. With a strong presence in Scottsdale, Arizona, and offices globally, we work towards advancing imaging science, technology, and services to bring curative technologies to humankind.

Job Description
The Clinical Data Specialist will be responsible for programming and testing solutions to generate high-quality reporting and workflow automation from clinical database sources. This role involves oversight of data processing activities and management of medical imaging assessments that contribute to primary analyses for clinical trials research.

Responsibilities
- Implement imaging workflow support automation according to project requirements using SAP Business Objects
- Develop reusable macros, templates, and utilities for data cleaning and reporting
- Prepare study monitoring reports and dashboards
- Maintain high-quality technical documentation
- Develop and validate code according to SOPs, industry best practices, and regulatory standards for clinical research
- Implement defensive programming tactics to avoid errors whenever possible
- Troubleshoot and debug programming logic
- Maintain version control on programming solutions released into production
- Establish and follow standardized programming procedures and written work instructions
- Provide programming support for study team members from study startup to study closure
- Participate in the design, development, and support of clinical data management systems
- Proactively communicate progress updates on assigned projects to internal and external stakeholders, as appropriate
- Participate in meetings, discussions, and briefings with upper-level management
- Plan and prioritize personal workload to meet specified completion dates
- Provide mentoring and training to other programmers and staff
- Promote awareness of emerging industry standards and best practices in clinical programming

Requirements
- Bachelor's or Master's degree in Life Science, Computer Science, or related field
- Minimum 4-6 years of experience in programming with at least 2-3 mainstream business intelligence software platforms
- At least 1-3 years of prior experience in a healthcare or clinical research environment
- Advanced demonstrable experience with SAP Business Objects, including Web Intelligence and Universe Design Tool
- Knowledge of pharmaceutical development process, clinical research, clinical data management, and clinical information systems preferred
- Experience working in a regulated environment preferred
- Excellent oral and written English language skills
- Positive attitude, promoting a team spirit and professional environment
- Detail-oriented with strong organizational and analytical problem-solving skills
- Understanding of best practices pertaining to software life cycle methodologies, ICH-GCP, 21 CFR Part 11
- Knowledge of software version control practices for maintaining reusable code and shared programming projects over extended periods of time
- Ability to learn new systems and function in an evolving technical environment
- Ability to successfully work independently and together with international teams


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