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Senior Data Operation Programmer
PHASTAR
posted 2mon ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
- Create eCRF specifications, design, develop and validate clinical trial setup process
- Create edit check specifications and setup edit checks at trial level
- Create and implement UAT scripts to test the setup of the clinical study
- Setup different instances of study URL(eg: UAT, production, testing etc.,)
- Setup and configure user accounts for study teams
- Setup and manage blinded and unblinded study configurations
- Be the SME for all database related activities
- Setup, configure, validate and integrate other modules within the EDC ecosystem such as coding, integration of IRT, safety system, local labs etc.,
- Knowledge of creating custom functions within EDC systems
- Work closely with EDC vendors regarding any tool related issues in the system
- Ability to troubleshoot database setup as per study needs
- Prepare, test and implement post production changes as per study needs
- Archive and retire the study URL after database lock
- Partner with appropriate team members to establish technology standards and governance models
- Establish and support business process SOPs.
- Oversee system delivery life cycle in collaboration with appropriate partners including Clinical Operations, Clinical Supplies, IT, and Quality organizations
- Be a primary change agent to ensure adoption of new capabilities and business process
- Be the contact for Clinical Technology vendors to ensure established milestones are met with the highest degree of quality.
- Work with leaders to resolve issues affecting the delivery of clinical trials
- Collaborate with standards team in creating standard CRF libraries for study level consumption
- Work closely with data engineers and data management programmers at study level integration and delivery
- Lead technology vendor oversight activities.
- Be a process expert for operational and oversight models.
- Partner with appropriate team members, technology vendors, and CRO partners to avoid and resolve risks.
- Confirm archival and inspection readiness of all Clinical Technology Trial Master File (TMF) documents
- Participate in preparing function for submission readiness and may represent Clinical Information Operations (CIO) group in a formal inspection or audit.
- Track study deliverables and evaluate study metrics to mitigate risk for major data management deliverables.
- Adaptable to new ways of working using technology to accelerate clinical trial setup
The skills and experience you ll bring to the role
- BSc or above in Life Sciences, Mathematics, Computer Science or related discipline.
- Experience working within life sciences/clinical trial environment.
- Minimum 2 years experience in Veeva.
- Build datasets on their own experience and postproduction changes.
- Experience developing database from Protocol, experience working with changing Specifications and stringent timelines Have lead experience and EDC experience.
Employment Type: Full Time, Permanent
Functional Areas: Analytics & Business Intelligence
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What PHASTAR employees are saying about work life
based on 6 employees
Flexible timing
Monday to Friday
No travel
PHASTAR Benefits
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