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RTSM Solutions Engineer

2.00 to 6.00 Years   Bangalore   02 Mar, 2021
BioClinica
Job LocationBangalore
EducationNot Mentioned
SalaryNot Disclosed
IndustryFMCG / F&B
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

Primary ResponsibilitiesServe as primary resource for client design consultations by:

  • Analyzing sponsor requirements against system capabilities to determine implementation recommendations and best practices
  • Demonstrating a superior comprehension of internal applications, such as Trident IRT; guiding clients towards an optimal implementation both from a design complexity and from a site experience perspective
  • Providing technical expertise for the requirements process and working to continuously move internal and external specifications discussions in a forward and positive direction
  • Facilitating discussions between internal and external resources to ensure that the key stakeholders and SMEs are represented and that the design reflects expert opinion
Implement and review study configurations by:
  • Configuring study specific implementations within a robust web based UI for Trident IRT based on study protocols and specifications
  • Conducting demonstrations of system implementations to clients during the development process
  • Soliciting client feedback during demonstrations and making adaptations to the configuration in real time when possible
  • Performing tasks associated with study configuration such as generation of kit lists, staging of data, and liaising with internal teams
Responsible for developing and managing RTSM User Requirements by:
  • Gathering, analyzing, refining, and finalizing user requirements from multiple sources in an iterative manner. Ensuring that a product/study will be delivered to the Customer in timely and accurate manner
  • Reviewing specification documents to ensure requirements are present and in the correct format
  • Developing the systems specifications including the User Requirements Specification (URS) from the study protocol, integrations with external systems, and other supporting applications such as reports
  • Coordinating the schedules of internal and external resources to ensure timely submission of requirements throughout the specification and design processes
  • Translating product features and functionality to the requirements definition stage to reduce confusion and conflict during the testing and go live phases of a study
Secondary ResponsibilitiesMaintains Quality Service and Departmental Standards by:
  • Reading, understanding and adhering to organizational Standard Operating Procedures (SOPs)
  • Working closely with QA for clarification and documentation of deviations to SOPs
  • Assisting in establishing and enforcing departmental standards
  • Participating in the modification of company SOPs related to IRT Services
  • Attending and participating in applicable company sponsored training
Contributes to team effort by:
  • Exploring new opportunities to add value to organization and departmental processes
  • Helping others to achieve results
  • Performing other duties as assigned
Maintains Technical Knowledge by:
  • Attending and participating in applicable company-sponsored training
Experience
  • 4 years experience in clinical trials experience within a CRO or pharmaceutical research organization required; preferably in a business analysis or project manager related role.
  • 2 years IRT Experience in business analysist and/or building configurations and specifications
  • 2 years experience in customer facing role
  • Proven ability to effectively lead a diverse team from requirements definition to product sustainability
  • Demonstrable detailed knowledge of interactive response technologies, drug supply, randomization strategies
  • General knowledge of regulatory guidelines from ICH, FDA, EMEA
EEO StatementBioclinica is an equal opportunity employer. Bioclinica evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.Collaboration, Continuous Learning, Critical Thinking, Organizational Awareness, Results Orientation, Service Orientation,

Keyskills :
standard operating proceduresclinical trialscritical thinkinguser requirementsservice orientationregulatory guidelinessystem implementationspharmaceutical researchcroichirtlistscolorfda

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