Clin Systems Spec 1

3 semanas atrás

Sao Paulo, Brasil IQVIA Tempo inteiro

Job Overview
Provide project related assistance for assigned complex project(s), sites and project teams. Lead teams functionally, where assigned, including awareness of scope of work, budget, and resources. Ensure all work is conducted in accordance with SOPs, policies and practices, good clinical practices and applicable regulatory requirements and meets quality and timeline metrics.

Essential Functions
- Support projects within a specific therapeutic project unit, country, region or client, as assigned.
- Set up, maintain, and provide technical support for clinical systems for assigned projects as required on systems.
- Ensure the consistent use of designated clinical systems and/or procedures for assigned projects
- conduct QC checks within a project, providing appropriate reports to PMs/CTLs to ensure better quality data.
- Maintain interfaces for each project as needed and develop client interfaces on request.
- Participate in user testing of new enhancements/functionality and/or review of associated procedures, training and documentation.
- Identify and record quality problems
- suggest, initiate, recommend or provide solutions as appropriate.
- Maintain awareness of overall developments in the field of clinical research.
- Understand financial and performance metrics requirements within region and/or project.
- Generate the newsletter and other systems communication on a monthly rotation.
- Receive the specific training for the position in order to update their knowledge
- Enter new Investigators/Sites into the respective databases and keep this information updated as necessary by region.
- Utilize system technical expertise to produce ad-hoc queries and metric reports providing information essential to business requirements.
- Provide training, coaching and support to local Clinical Systems Specialists including communication of new procedures, system changes, etc.
- As agreed with Clinical Systems Manager, update training material with new procedures, system changes.
- Cordinate and collaborate with various project stake holders.
- Act as SME/mentor/buddy for new joiners and support new joiners with system/process trainings.
- May be assigned role of systems expert - guiding teams on using of systems, creating guidance documents, updating trainings relevant to the systems and any new updates available in the systems. relaying the trainings to the team and be available to address the quesries for the teams.
- Perform complex processes and tasks that eventually result in high quality deliverables that are completed according to service level agreements (SLAs) and within project timelines
- Establish and maintain effective project/ site communications
- Create and maintain relevant project documents
- Ensure accurate completion and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific information
- Review, evaluate and recommend modifications to designated processes
- Participate in document management (creation, review, maintenance, storage, as applicable)
- Participate in (study) team meetings and implement action items
- Collaborate with the project lead/team members in creation/review of study documents
- Setting quality standards and reviewing deliverables to the same for process tasks.

**Qualifications**:

- Bachelor's Degree Health or Biological science Req
- Typically requires Minimum 3 years of relevant experience.
- Demonstrated knowledge of all relevant associated SOPs/Work Instruction and other guidelines.
- Working knowledge of designated clinical system(s) and/or processes, applicable SOPs and regulations and understanding of system interactions/interdependencies.
- Knowledge and ability to work cross-functionally and an understanding of IQVIA project team structure.
- Basic computer skills, including knowledge of MS Office suite
- Effective problem-solving skills
- Effective communication and interpersonal skills
- Effective organizational skills and attention to detail
- Ability to run ad hoc queries and reports for a given project/InnTrax
- Ability to work independently on assigned projects with mínimal supervision
- Ability to handle multiple priorities and meet deadlines
- Ability to independently conduct designated clinical system and/or process training, as well as customer demonstrations/presentations (as needed)
- Ability to establish and maintain effective working relationships with co-workers and managers

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