Associate Project Support
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 provide general assistance to Project Management Team and provides administrative support to the Department's Managers for any data change requests regarding sites and users and to facilitate the client requirements for Language translation to be used in the clinical study. This role involves interaction and coordination with the Development team and in conjunction to external Vendors to facilitate in the timely translation as a requisite for the study.
- Management of site and user imports and updates.
- Coordination of shipment of PIN envelopes to system users.
- Distribution of study specific user guides as per Site and user support request (SUSR).
- Being backup for creating User guides in absence of PMG / respective resource.
- Support Project Managers with data change control process.
- Administrate support to Team Lead and Global Project Support Manager.
- Ensure that work is conducted in compliance with standard processes, policies and procedures and meets quality and timeline metrics.
- Creation of Site and user support request (SUSR), Cenduit Sites and Users templates for new studies training the client on the process of Sites and Users.
- Sending tracking reports for studies on weekly or monthly basis upon clients requests.
- Performing post reviews on data change request across the department.
- Adding/updating the sites information in Patient Reminders Production environment. (Applicable only if Patient reminders are integrated in study)Creation of Text IDs based on the client/internal request for translation.
- Coordinate with the development team for mapping the text IDs into the study.
- Coordinate with vendors for the translation into the language requirement for the study.
- Import the translated files to the language ID created, and sync with the server to upload.
- Maintain administrator responsibility of coordinating and processing the Purchase Orders for the translation charges.
- Reporting updates to stakeholders for TextID excel sheet and Translations related updates.
- Scrutinize translation files on need basis.
- Demonstrates effective oral and written communication as well as commitment to keeping others informed, proactively passing on relevant information to others.
- Demonstrates understanding of internal and external customer needs and concerns.
- Is responsive to customer needs and maintains a good level of customer service.
- Ensures that all work meets quality standards and supports others to achieve good quality.
- Delivers a quality service and work products on time.
- Recognizes and evaluates risks appropriately under guidance of experienced colleagues.
- Proactively looks to learn and develop knowledge.
- Plans work well to ensure that timelines are met.
- Prioritizes tasks appropriately and delegates tasks where required.
- Keeps key stakeholders informed of progress, changes or impact on timelines.
- Demonstrates effective teamwork, working with and supporting colleagues.
- Demonstrates commitment and enthusiasm to Cenduit and the aims of the company.
- Demonstrates accountability when appropriate.
- Bachelor's degree and/or technical diploma.
- 1-3 years clinical research, administrative assistant, or project management experience; or equivalent combination of education, training and experience.
- Experience working in a customer service/customer facing environment.
- Good communication skills in understanding client requirements and coordination with internal and external customers.
- Good knowledge on MS Office, Basic SQL
- Exposure to usage of tools like Dictionary Trackers, Dictionary Diff etc.
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