RTSM Solutions Engineer

Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation. 

Job Title: RTSM Solutions Engineer                      

Location: USA Remote                

Function: Service Delivery      

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Serve as primary resource for client design consultations
• 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

Responsibilities Maintains 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

EDUCATION AND EXPERIENCE REQUIRED:

• Bachelors degree or higher education required
• 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 analysis 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

COMPENSATION & BENEFITS:

Sitero proudly offers an impressive compensation package and benefits, including a competitive salary, Variable pay, paid time off, and healthcare and retirement benefits.

EMPLOYMENT TYPE:

Full Time, Permanent

COMMITMENTS:

• Standard Hours 40 hours per week, one hour lunch, Monday – Friday. Additional hours as needed.
• Willing to work in shifts as and when needed.

DISCLAIMER: 

Sitero is an equal opportunity employer and welcomes all job applicants.  All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

Compensation$75,000-$90,000