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.
This position is designed to ensure that the expectations of a clinical systems design project (IRT, IVRS, IWRS system) are met, to the client's satisfaction, and in accordance with SOP's, policies, and practices.
The Project Manager will be responsible for managing the project life cycle; this includes discussions with clients, development of the project specifications, documentation of project set up, coordination with overseas technical operations team, and management of all project related activities through to project completion.
This individual will be the primary point of contact to the client teams; as such, the ability to communicate effectively, as well as to build/maintain relationships with clients will be essential to professional success.
* Manage all aspects of designing, developing, and implementing Cenduit's Interactive Response Technology (IRT) clinical system. (Also known as Interactive Voice Response/Interactive Web Response; IVR/IWR,or IxRS).
* Coordinate and communicate all internal technical activities ensuring that all services and features are complete in accordance with client timelines.
* Author requirement specifications for study systems and review other project documentation to support the development and validation of a software system.
* Work with the client and project team to finalize the requirement documents to meet client deliverables.
* Act as a liaison between the client and the technical operations team throughout the entirety of the Cenduit system lifecycle (SLC), throughout the configuration and validation of project specific systems, during System Quality Review (SQR), System Requirements Testing (SRT), User Acceptance Testing (UAT) and the "Go Live" process.
* Gather user requirements and document functional specifications.
* Responsible for ensuring that all system design activities are completed in a timely manner, and meet the client and study requirements. This will include regular communication with team members to ensure project tasks are on target.
* Assess the protocol and other client provided materials in conjunction with IRT system standards, to design supply chain solutions for medication management.
* Lead problem solving and resolution efforts by assisting with issue identification, resolution, documentation, and escalation.
* Participate in both internal and external meetings utilized to establish system requirements. Use appropriate project planning tools (e.g. Microsoft Project) to communicate milestones, critical path activities, and other necessary updates.
* Serve as primary contact with client to ensure communication is maintained and project schedules are adhered to.
* Travel to conduct training at monitor/investigator meetings.
* Supervise the maintenance of project management information and database/tracking systems.
* Develop and maintain good communication and working relationships with internal as well as external teams.
* Partner with other project managers on a cross functional basis to develop and implement business process improvement activities.
* Mentor support staff in relation to study specific projects, processes and procedures.
* Perform other duties as required and directed by management team, including general Project Management work for new studies and studies in maintenance.
* Some travel required - 10 - 20%
* Desire and motivation to succeed in a fast-paced, growing, global company.
* Strong communication skills, both verbal and written.
* Excellent presentation and negotiation skills; ability to present in front of an audience.
* Strong client management skills, including interpersonal skills; ability to build rapport and credibility with senior-level clients and internal partners.
* Superior time management skills and strong attention to detail.
* Analytical decision making.
* Team player & flexible.
* Good computer skills, including knowledge of MS office applications.
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.
* Business analyst experience in a software environment preferred.
* Experience in a clinical, CRO, or pharmaceutical operational function preferred.
* Experience managing software development lifecycles (SDL) a plus.
* Experience with clinical technologies; e.g., EDC, IRT, IVRS/IWRS, IxRS preferred.
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.