Job Description

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.
Responsibilities

Client service (40%)

• 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

Data Changes (20%)

• 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

Helpdesk Support (20%)

• 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

Other tasks (20%)

• 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

Required Knowledge, Skills, and Abilities

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. Bachelor's degree or equivalent combination of education, training and experience. Proven clinical research or project management experience. Experience working in a customer service environment preferred.