Help change the world of the life sciences industry – Join us!

Our mission is to empower clinical trial sponsors, through best-in-class software and services, to optimize the efficiency of disclosure activities, maximize trial data transparency, and foster more informed, engaged patients through open research sharing. TrialScope is the global leader in clinical trial transparency and compliance. Our customers include 9 of the top 10 and 20 of the top 30 pharmaceutical and biotech companies in the world. We are in Jersey City, NJ in Harborside Financial Plaza across the river from New York City first PATH stop.

Our current job openings are listed below.

Software Automation Test Engineer

Description

The ideal candidate will be a high performing individual who is passionate, ambitious, and possess excellent problem solving skills coupled with the ability to work well within a team to deliver smart, consumer and market driven solutions. ...

Key Responsibilities 

  • Design and build end to end and regression automation tests for all layers of the application (UI and API).
  • Make recommendations to enhance existing test suites and test cases.
  • Collaborate with Test Manager to plan and distribute automation testing activities for remote team.
  • Collaborate with Test Manager in planning and implementing Performance Testing.
  • Provide daily status reports of testing progress and issues (including remote team status on tasks).
  • Participate in all aspects of the Agile process (Daily meetings, Grooming, Planning, Retrospective and demos).
  • Support an enhance the existing testing process by suggesting continuous improvement initiatives.
  • Help developers understand how to write more reliable code by providing test insides.
  • Provide mentoring and training on automation for remote team and new team members.

Experience and Skills

  • 4+ relevant work experience in development and/or testing automation role.
  • Good understanding of object oriented programming.
  • Understanding of automation design patterns and software testing principles and methodologies.
  • Experience working with API / Restful services (preferred).
  • Experience working with industry automation tools, such as Selenium, Protractor, HP UFT/QTP, SoapUI strongly preferred (preferred).
  • Experience in Continuous Integration environments (preferred).
  • Basic knowledge of Agile Methodologies
  • An entrepreneurial attitude with a strong sense of reliability and ownership
  • The ability to multi-task, context switch, and be flexible enough to go with the flow
  • Strong written and verbal communication
  • The ability to easily learn new applications and tools
  • Experience working in a mobile, web, or back-end application development environment

Compensation & Benefits

TrialScope is an Equal Opportunity Employer. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.

We have a full package of competitive benefits and perks available:

  • Medical Benefits, Dental Benefits, Vision Benefits
  • Flexible Spending Account (FSA), Health Savings Account (HSA)
  • Basic Life and Personal Accident Insurance, Basic Disability Insurance, Voluntary Group Life Insurance, Voluntary Personal Accident Insurance
  • Adoption Assistance
  • Commuter Benefits
  • Educational Assistance
  • Dependent Child Care Spending Account
  • 401k Plan with Employer match
    • 100% employer match up to first 3%
    • 50% employer match of next 2%
  • Paid Time Off (PTO) – 15 days
  • Paid Holidays (9 + 1 Floating)
  • Maternity leave
  • Fitness club membership reimbursement
  • Free lunch (1x per week) and snacks

Please send your resume to jobs@trialscope.com

Senior Product Business Analyst

Description

The ideal candidate will be a high performing individual who is passionate, ambitious, and possess excellent problem solving skills coupled with the ability to work well within a team to deliver smart, consumer and market driven solutions....

Key Responsibilities

  • Create user stories, acceptance criteria, and manage tickets
  • Assist the Product Manager/Program Manager to develop necessary artifacts to define and deliver products
  • Provide feature testing of end-to-end features
  • Respond to reported issues and work with engineers to troubleshoot and develop tickets
  • Work with customers and internal teams to gather requirements, confirm solutions and gather consensus
  • Strong technical writing and documentation

Experience and Skills

  • 4+ years of prior work experience in a similar or related role
  • Basic knowledge of Agile Methodologies
  • An organized and systematic approach to problem solving
  • The ability to partner within a multi-functional team that includes engineers
  • An entrepreneurial attitude with a strong sense of reliability and ownership
  • The ability to multi-task, context switch, and be flexible enough to go with the flow
  • Strong written and verbal communication
  • Experience working with software and data
  • An understanding of basic analytics and reporting
  • The ability to easily learn new applications and tools (ex: issue tracking system)
  • A basic understanding of marketing and business development principles
  • Experience working in a mobile, web, or back-end application development environment
  • Analytics and SQL experience

Compensation & Benefits
TrialScope is an Equal Opportunity Employer. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.

We have a full package of competitive benefits and perks available:

  • Medical Benefits, Dental Benefits, Vision Benefits
  • Flexible Spending Account (FSA), Health Savings Account (HSA)
  • Basic Life and Personal Accident Insurance, Basic Disability Insurance, Voluntary Group Life Insurance, Voluntary Personal Accident Insurance
  • Adoption Assistance
  • Commuter Benefits
  • Educational Assistance
  • Dependent Child Care Spending Account
  • 401k Plan with Employer match
    • 100% employer match up to first 3%
    • 50% employer match of next 2%
  • Paid Time Off (PTO) – 15 days
  • Paid Holidays (9 + 1 Floating)
  • Maternity leave
  • Fitness club membership reimbursement
  • Free lunch (1x per week) and snacks

Please send your resume to jobs@trialscope.com

Senior Front-end Architect/Developer

Description

We are looking for a passionate, experienced top-notch hands on architect to join our development team in a total rewrite of TrialScope’s SaaS product’s front-end. The person must have experience with React, our technology of choice. The right person will be able to The ideal candidate will be able lead, mentor, and develop, as well as work with stakeholders, including business, product, and UX team members to influence the application architecture and design.  ...

Key Responsibilities

  • Lead, develop and collaborate with team members on our most critical product improvement, a total technology rewrite of our browser based front-end
  • Research, identify and rollout new technology components
  • Ensure best practices are followed and contribute to improving how we get things done
  • Excel at risk management, multivariable problem solving, estimation, and technical team management

Experience and Skills

  • 10+ years of modern front-end development experience, familiar with current technologies & trends and 4+ of SaaS product design and development
  • Expertise with React required
  • Expertise with full stack end to end development utilizing .NET Framework and C#.
  • Expertise in platform product (services) architecture
  • Strong development lifecycle tools and practices (e.g. Microsoft Visual Studio, Git/TFS, etc.) experience
  • Strong database skills in Microsoft SQL Server, and NoSQL (e.g. MongoDB, Cosmos)
  • Expertise in HTML/CSS, JavaScript and UI/UX design
  • Familiarity with common open source projects, and licensing a plus
  • Skills with XML / XSLT a plus
  • Excellent analytical and problem-solving skills
  • Excellent communication and organizational skills
  • Strong interpersonal, leadership , time management and prioritization skills

Compensation and Benefits
TrialScope is an Equal Opportunity Employer. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.

We have a full package of competitive benefits and perks available:

  • Medical Benefits, Dental Benefits, Vision Benefits
  • Flexible Spending Account (FSA), Health Savings Account (HSA)
  • Basic Life and Personal Accident Insurance, Basic Disability Insurance, Voluntary Group Life Insurance, Voluntary Personal Accident Insurance
  • Adoption Assistance
  • Commuter Benefits
  • Educational Assistance
  • Dependent Child Care Spending Account
  • 401k Plan with Employer match
    • 100% employer match up to first 3%
    • 50% employer match of next 2%
  • Paid Time Off (PTO) – 15 days
  • Paid Holidays (9 + 1 Floating)
  • Maternity leave
  • Fitness club membership reimbursement
  • Free lunch (1x per week) and snacks

Please send your resume to jobs@trialscope.com

Senior Project Manager

Description

The Senior Project Manager will manage and successfully deliver implementations of the TrialScope product suite. The Senior Project Manager will support the TrialScope Implementation team on assigned projects from inception to completion, handling day to day project management activities. He/She will report to the Director, Implementation Services within the Chief Customer Officer team. The Senior Project Manager will work closely with the business development, technical and support teams taking direction on specific tasks that will support project success. While the Senior Project Manager will be the customer’s main point of contact throughout the implementation, the overall customer account will be managed by the Customer Success Manager. ...

Key Responsibilities

  • Manage and deliver successful customer implementations
  • Build customer loyalty by providing exceptional service during Implementation
  • Collaborate with the technical team to ensure application meets customer needs
  • Ensure that project teams follow TrialScope standard operating procedures (SOPs)
  • Assist customer with current and future state business process definition
  • Interact with Support team to ensure a smooth hypercare period and handover post implementation
  • Maintain a familiarity with global regulatory requirements and climate
  • Assist Director in meeting annual goals including revenue & utilization targets
  • Serve as primary point of contact with assigned key accounts
  • Schedule and run project meetings and routine governance meetings
  • Handle key account conflict resolution; escalates conflicts to director where appropriate
  • Provide frequent and routine updates on key account project status

Education and Experience

  • Bachelor’s Degree or higher, preferable in life sciences or related field
  • Minimum experience: 7+ years as a project manager
  • Demonstrated ability to manage budgets, timelines and resources across multiple concurrent projects, tracking progress against baseline estimates and ensuring on-time delivery to customers
  • Ability to work with all levels of management, staff, outside contractors, vendors, and customers, and to resolve and negotiate conflicts or problems with tact, diplomacy and composure

QA Validation Analyst

Description

Under general direction of the Director QA, Privacy & Compliance, the QA Validation Analyst supports the computer system validation process by ensuring alignment of operations with system requirements, corporate policies, industry standards, and applicable regulations. This individual will identify gaps in the software validation program, conduct effective CSV assessments, execute validation testing, defect resolution and complete validation deliverables. The individual should be a good team player with good communication. motivation, team building and mentoring skills with the ability to work independently and in rapport with Management, Business Analysts, Functional Leads and Project Managers....

Key Responsibilities

  • Assists in the development, planning and tracking of the validation of computer systems developed by the TrialScope Agile development teams
  • Expertise in all phases of an Agile based Software Development Life Cycle (SDLC) and Computer System validation (CSV)
  • Works with the project teams to develop validation strategies for projects and works closely with project managers and program managers to meet the deadlines
  • Provides leadership to the technical and business analysis team members to ensure compliance with system requirements, corporate quality standards, GDPR guidelines, Privacy Shield principlies, GxP requirements and FDA regulations (21 CFR part 11, Annex 11 and/or 21 CFR Part 820)
  • Maintains production computer systems in a regulatory compliant state, monitors all modifications or changes to systems or processes, initiates change control / revalidation as required and ensures a continual state of inspection readiness per the requirements of the Quality Management System (QMS)
  • Reviews and approves Validation Plans (VP), Qualification Protocols (IQ/OQ/PQ), Trace Matrices (RTM), Test Plans, Risk Assessments (RA), and Final Validation Summary Reports (VSR) by providing instructions and guidance for the creation of validation deliverables
  • Monitors the testing efforts of the IS/IT and business teams with regards to test coverage and test strategies
  • Guides the business and development staff to create thorough, accurate and comprehensive test scripts
  • Develops, maintains and executes validation audit test scripts, test metrics and generates reports for management use in determining project and applications validation status
  • Investigates, gathers and furnishes additional information about functional defects including log files, procedures to reproduce, etc., communicates concerns, and retains contact and continues discussion with the development staff as testing progresses to ensure test results are appropriate and meet validation needs
  • Performs post-execution audit reviews of test cases for completeness, accuracy, and adherence to policies and procedures
  • Provides technical decision making regarding validation strategies for complex projects
  • Maintain accountability for training validation test team on validation methods
  • Oversees overall document management for all validation deliverables including, but not limited to the deliverables called out in the SDLC SOP
  • All aspects of validation package contents
  • Assisting in the routing and approval process of documents
  • Archiving all CSV documentation
  • Assembles data for special software validation reports
  • Performs computer system regulatory compliance assessments for new programs/or products per policies and procedures.
  • Must be a Team player with the ability to work independently. Communication, motivation, team building and mentoring skills are required
  • Support Quality Assurance through consultation on regulatory standards and compliance regarding validation activities
  • Participates in internal and external Regulatory audits and external vendor audits
  • Provides support for other CSV-related initiatives and validation/quality improvement projects
  • Additionally, may assist with corporate validation initiatives and assist with the documentation of validation efforts to meet FDA compliance requirements, when applicable

Education and Experience

  • Working knowledge of FDA/GxP; Strong working knowledge of Pharmaceutical (21 CFR 11, Annex 11 and/or 820)
  • Regulations and software technical aptitude
  • Ability to prepare, execute, and analyze validation studies and validation protocols
  • Ability to communicate project status, issues, risks, plans, etc. within the organization
  • Demonstrated experience working in a regulated environment requiring adherence to government or regulatory body policies and procedures
  • Demonstrated knowledge of Quality Management Systems tools
  • Should be able to lead software validation projects and change control efforts
  • Able to respond/react with appropriate urgency/professionalism and make decisions under pressure
  • Supports goals and initiatives tied to the Quality Plan and departmental goals
  • Ability to interface effectively with cross-functional teams resulting in overall regulatory compliance
  • Ability to communicate effectively both orally and in writing
  • Good analytical, problem-solving and conceptual skills
  • Strong attention to detail
  • Ability to resolve system validation issues effectively and efficiently

TrialScope is an Equal Opportunity Employer