- Bangalore, India
Cenduit LLC is the largest IRT (interactive response technology) specialist in the world with the expertise to empower study sponsors for success by implementing a completely personalized system that puts them in control of their clinical trials. Cenduit was founded in May 2007 and emerges from a robust tradition of clinical development and supply chain expertise from two world leaders, Quintiles and Thermo Fisher Scientific.
Meeting the needs of investigator sites and patients, Cenduit offers clinical supply chain intelligence and clinical operations know-how through its IRT-driven services: rapid study start-up software, patient randomization (RTSM), patient reminders, drug supply management, and eClinical integration. Cenduit has over 500 experts worldwide in the US, UK, Switzerland, India and Japan, with clinical trial experience in more than 100 countries, interacting with more than 600,000 patients at more than 32,000 sites.
The main purpose of this role is to support the project managers in IRT in study set up and maintenance activities.
Data changes (50%)
- Author data change requests based on client's needs.
- Coordinate the implementation and ensure closure of the data changes
Maintenance tasks (30%)
- Take appropriate actions to resolve the tickets where needed
- Investigate issues and manage the resolution or escalate to other groups for further investigations - GTs, Ops tickets
- SCR support - perform SQR Data Setup support
- Reconciliation - Interim/study End analysis from DM
- Draft study specific user guides, SUSR's , HDSG and finalize based on PM comments
- Prepare IM slides, Update communication/ VMP
Closeout Tasks (5%)
- Study closeout Checks
- Download reports and store in the SharePoint
- Other related duties as required by business need
- Strong customer service ethics, always providing excellent service to all stakeholders
- Accountable to perform tasks on-time, and with high quality.
- Excellent written and verbal communication skills
- Strong team player with ability to work independently
- Solid organizational skills including attention to detail and multi-tasking skills
- Good problem solving and analytical skills
- Ability to learn a technical system
- Stong working knowledge of Microsoft Office
- Bachelor's Degree in scientific field or equivalent.
- 5-10 years experience working within a regulated environment with in depth familiarity with FDA and international regulations such as 21 CFR Part 11, GCP/E6, EU Directive 95/46/EC, etc. Prior regulatory inspection history strongly desired.
- 3-7 years experience in Quality Assurance role in a regulated environment or ISO 9000 certified company.
- Prior management experience
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