Associate Technical Project Analyst
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 the role is to manage technical aspects of system builds working closely with the system design project manager. The role will be involved in study build process from kick off meeting to go live and build related activities during maintenance phase. The main responsibilities will be around UAT management, author and update specification documents (SRS, data transfer specs, report specs), initiate and coordinate implementation activities with technical operation groups and technical guidance and support of project management team members in build and maintenance.
User Acceptance Testing (UAT)
- Write UAT scenarios and plans according to client specific guidelines.
- Setup UAT database and perform dry run.
- Coordinate support activities during UAT execution, issue tracking and resolution.
- Support Study Go Live activities
- Update System Requirement Specification (SRS) document.
- Review Client Data Transfer Specifications.
- Author Cenduit Data Transfer Specifications.
- Update User Requirement Specification (URS) document
- Author URS addendum document
- Complete PM related parts of parameter checklist
- Review and sign off validation related documentation.
- Lead problem solving and resolution efforts by assisting with issue identification, resolution and escalation.
- Manage SCR process for technical changes working with the client services project manager.
- Develop study data reports for internal use.
- Handle the translation coordination activities (text id creations and translation packaging and translation upload to the system) as required.
- Partner with other project managers on a cross functional basis to develop and implement business process improvement activities.
- Provide input into the writing and review of standard operating procedures (SOPs).
- Assist in the development of training materials and instructions for departmental use.
- Organize and deliver training for project support staff/other members of Cenduit, as appropriate.
- Develop; maintain good communication and working relationships with internal and external teams.
- Perform other duties as required and directed by Cenduit management team, including general Project Management work for new studies/maintenance studies.
- Ensure that all build project work is completed to the sponsor's satisfaction, ensuring quality deliverables on time and within budget and in accordance with the Cenduit SOPs and established timeline metrics.
- Good organization, interpersonal and communications (written and verbal) skills are essential including technical and business writing and editing.
- Ability to communicate technical concepts to non-technical audiences, and business concepts to technical audiences.
- Strong customer service ethic with ability to establish and maintain effective working relationship.
- Good problem solving/analytical skills.
- Demonstrated ability to deliver quality results within appropriate timeline metrics.
- Strong software and computer skills including good working knowledge of MS office applications.
- Able to work independently as well as part of a team
- Bachelor's degree with minimum 0-2 years' experience.
- Experience with IVR or Electronic Data Capture is preferred.
- Experience working in a customer oriented environment.
- Experience with the clinical drug development process or software project management.
- Experience in SQL, Crystal/Business Object reporting solutions preferred.
- This role will require extensive use of the keyboard and therefore repetitive motion of the fingers and will involve sitting for extended periods.
- Domestic and overseas travel up to 25% may be required.
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