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 manage the assigned IRT studies in a way that ensures all patients get the study drug on time and the study and data integrity are maintained from study go live to close out.
An important aspect of this role is to develop the relationship with the client while the study is ongoing in such a way that they look to Cenduit as a trusted partner.
- Act as main point of contact for the client during study maintenance.
- Organize or participate in regular client meetings.
- Respond to all client requests in a timely manner.
- Manage budget and Change Orders (COs) as required.
- Provide regular updates to client on study related information.
- Proactively review supply strategy for improvements and identify risks.
- Periodically review study data to identify trends or issues.
- Author data change requests based on client’s need.
- Pre-approve data change requests raised by Helpdesk staff.
- Coordinate the implementation and review of the data changes.
- Review Helpdesk tickets that get escalated from Helpdesk to Project Management.
- Take appropriate actions to resolve the tickets as quickly as possible.
- Initiate updates to Helpdesk study guides.
- Draft study specific user guides and finalize based on PM comments.
- Investigate issues and manage them through to resolution.
- Review study alerts and action or escalate as appropriate in a proactive way.
- May provide information and training to new hires.
- May attend Investigator Meetings, or participate in client audits (representing study).
- May manage System Change Requests (SCRs) for bug fixes other than the category of “PMG”.
- Work with a system design PM, assisting with User Guides and Helpdesk study guides for SCRs as needed.
- Other related duties as required by business need for new studies and studies in maintenance.
- Some travel required: 10-20%.
- Strong customer service ethic, always providing excellent service to both internal and external ‘clients’.
- Confident in working with external Clients.
- 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 (continued development of technical aptitude)
- Strong IT skills and working knowledge of Microsoft Office
Education & Experience:
- Bachelor’s Degree or equivalent combination of education, training, and experience.
- 5 - 7+ years of project management experience preferred.
- Client management experience required.
- Experience in a clinical, CRO, or pharmaceutical operational function preferred.
- Experience with clinical technologies; e.g., EDC, IRT, IVRS/IWRS, IxRS preferred.
Why is Cenduit a great place to work? Visit The Muse to find out more!
Cenduit offers equal employment opportunities without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, national origin, age, disability, genetic information, veteran or military status and other protected class characteristics.