TrialScope is the global leader in clinical trial transparency and compliance. Our customers include 14 of the top 30 Pharmaceutical and Biotech companies in the world, including 7 of the top 10. Our tools and systems enable our customers to make clinical trial information accessible to the public, helping researchers and patients more easily locate the clinical trials most useful to them. Capabilities include seamless clinical transparency and integration with internal data services such as CTMS platforms. Our technology offers a fully validated SaaS platform hosted in a private cloud.

Enrich your skills while helping the life sciences industry become more transparent to the public. We are located in Jersey City, NJ across the river from New York City.

Our current job openings are listed below.

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

Software Support Engineer

Description

As a Software Engineer for TrialScope, you are responsible for coding our software products features and fixes. In addition, developers may investigate customer reported issues, coordinate with customer support analysts, and contribute to maintenance releases....

Responsibilities

  • Work collaboratively with senior developers, business analysts, and support analysts to diagnose application issues and provide root cause analysis
  • Triage customer incidents and fulfill customer specific requests
  • Take ownership of reported issues and see problems through to resolution
  • Follow standard procedures for proper escalation of unresolved issues to the appropriate internal teams
  • Code and unit test system features and bug fixes
  • Assist the Implementation team in onboarding new customers.
  • Deploy application updates and provide IQ documentation.

Requirements

  • Bachelor level degree in Computer Science or related degree
  • 4+ years of experience developing .NET Web applications
  • Expertise with full stack end to end development
  • Experience with one or more modern JavaScript frameworks like
  • ExtJS or Angular.js or React.js preferred
  • Excellent analytical and problem solving skills
  • Excellent communication and organizational skills
  • Strong sense of ownership
  • Strong skills in Object Oriented Programming
  • Strong skills with .NET Framework and C#
  • Strong skills with XML / XSLT preferred
  • Experience with ORM frameworks (like nHibernate or Entity Framework) preferred
  • Experience with Microsoft Visual Studio and source control (Git/TFS)
  • Familiar with common Design Patterns and working knowledge SQL Server

To Apply

Please send your resume to jobs@trialscope.com

TrialScope is an Equal Opportunity Employer

Senior Software Engineer

Description

As a Software Engineer for TrialScope, you are responsible for coding our software products features and fixes. In addition, developers may investigate customer reported issues, coordinate with customer support analysts, and contribute to maintenance releases....

Responsibilities

  • Collaborate with other team members on shared items of work to ensure end to end on-time delivery of features
  • Work with support analysts to investigate application issues and provide root cause analysis
  • Design, code and unit test system features and bug fixes
  • Advise architects on best possible solutions to a given problem and drive feature designs
  • Provide estimation of work and ensure team is kept informed of progress and within budget and time commitments
  • Ensure best practice is followed and contribute to improving how we get things done Share your knowledge

Requirements

  • Bachelor level degree in Computer Science or related degree
  • 8+ years of experience developing .NET Web applications
  • Expertise with full stack end to end development
  • Expertise with one or more modern JavaScript frameworks like
  • ExtJS or Angular.js or React.js
  • Excellent analytical and problem solving skills
  • Excellent communication and organizational skills
  • Strong sense of ownership
  • Strong skills in Object Oriented Programming
  • Advanced skills with .NET Framework and C#
  • Strong skills with XML / XSLT preferred.
  • Experience with ORM frameworks (like nHibernate or Entity Framework) preferred.
  • Experience with Microsoft Visual Studio and source control (Git/TFS)
  • Familiar with common Design Patterns and working knowledge SQL Server.

To Apply

Please send your resume to jobs@trialscope.com

TrialScope is an Equal Opportunity Employer

Software Engineer

Description

As a Software Engineer for TrialScope, you are responsible for coding our software products features and fixes. In addition, developers may investigate customer reported issues, coordinate with customer support analysts, and contribute to maintenance releases....

Responsibilities

  • Collaborate with other team members on shared items of work to ensure end to end on-time delivery of features
  • Work with support analysts to investigate application issues and provide root cause analysis.
  • Code and unit test system features and bug fixes.
  • Advise senior developers and architects on best possible solutions to a given problem.
  • Provide estimation of work and ensure team is kept informed of progress
  • Ensure best practice is followed and contribute to improving how we get things done
  • Share your knowledge across the team

Requirements

  • Bachelor level degree in Computer Science or related degree
  • 5+ years of experience developing .NET Web applications
  • Expertise with full stack end to end development
  • Expertise with one or more modern JavaScript frameworks like ExtJS or Angular.js or React.js preferred
  • Excellent analytical and problem solving skills
  • Excellent communication and organizational skills
  • Strong sense of ownership
  • Strong skills in Object Oriented Programming
  • Advanced skills with .NET Framework and C#
  • Strong skills with XML / XSLT preferred
  • Experience with ORM frameworks (like nHibernate or Entity Framework) preferred
  • Experience with Microsoft Visual Studio and source control (Git/TFS)
  • Familiar with common Design Patterns and SQL Server

To Apply

Please send your resume to jobs@trialscope.com

TrialScope is an Equal Opportunity Employer

Sales Engineer – East Coast US

Description

As a Sales Engineer for TrialScope, you will report to the Director of Sales Engineering. The Sales Engineer works closely with TrialScope’s Business Development and Global Account Managers and the customer in the pre-sales process to identify and qualify their business/technical needs....

Responsibilities

  • The Sales Engineer is the domain expert working within a team of Business Development and Account Management members. The Sales Engineer is a “peer” of the customer and will be responsible for presenting application case studies through representative scenarios. Meetings are often conducted with senior business (CMO) and regulatory management (VP, Director) and will include stakeholders in IT and other functional groups
  • Consultant for the customer’s internal champion(s) to help assemble a comprehensive strategy for implementation of a clinical data disclosure solution to comply with all regulatory bodies (FDA, EMA, etc.)
  • Field expert responsible for first line domain (customer application) and technical (internal) expertise leveraging internal technical resources of TrialScope:
    • Lead the consultant technical qualification of a business/workflow for new customers. Responsible for creating and presenting analysis of TrialScope solution to customers as part of the consultative sale/value analysis
    • Work closely with CMO representatives responsible for complying to all regulatory bodies providing understanding how TrialScope’s capabilities can best address a customer’s regulatory requirements
    • Work together with Product Managers and Implementation Managers, to craft solutions that can be delivered to meet customers’ requirements
    • Responsible for technical lead for Request for Information (RFI) and Request for Proposals (RFP)
  • Workflow Support (Tools)
    • Responsible for defining customer workflows in the areas of disclosure to all required regulatory bodies and clinical data request. Aid in the understanding of the benefits of a “systems approach” to disclosure as compared to “one-off” process. Sales Engineer to provide technical expertise applied to the overall application, workflow and compliance requirements
  • Marketing
    • The Sales Engineer will work closely with Marketing and Product Management to adapt the positioning as the value proposition is exercised in the marketplace.
    • The Sales Engineer is responsible for presenting papers at conferences and trade shows

Qualifications

The ideal candidate would enjoy working with people and look for personal and professional growth by leveraging their technical experience in a commercial business environment. Candidate should have an entrepreneurial spirit with a desire to make an impact in the organization while fostering growth.

  • BS or advanced degree in Information Technology or Pharmaceutical development related degree
  • 5+ years’ experience in a multinational company with significant experience either working with companies servicing to or working within the Life Science industry
    • Experience in application development
    • Interest in software and informatics
    • Background in Life Science regulatory environment
    • Experience with TrialScope/PharmaCM disclosure solutions a plus
    • Experience developing presentations and presenting to senior level decision makers
  • Located on the US East Coast with preferred North Eastern resident (closer to corporate office and most US clients)
  • Ability to work independently (work from home office if applicable), as part of integrated project teams, and across a matrix of people and functional groups
  • Travel approximately 30-50%
    • The first-year travel may be more depending on the location, experience of candidate and associated training requirement
    • Travel focused on U.S.; there will be some additional travel internationally

To Apply

Please send your resume to jobs@trialscope.com

Head of Marketing

Description

As TrialScope’s Head of Marketing, you will be responsible for all facets of marketing including: PR, tradeshows, website, SEO and SEM, events, branding, demand generation for existing customers and prospects and marketing funnel optimization. ...

Key Responsibilities

  • Working with VP of Business Development and other Executive team members to set and manage overall marketing strategy
  • Develop TrialScope’s annual marketing plan
  • Manage and track marketing budget
  • Own the relationship between brand and account management and develop strong communications and tightly integrated programs between sales and marketing
  • Lead marketing team to develop key business metrics including MQL’s, SQL’s and opportunities
  • Develop robust reporting capability through Salesforce.com and other available tools ensuring real-time visibility of results vs. objectives

Education and Experience

  • BA/BS Degree Marketing, MBA preferred
  • This position requires travel to customer and non-customer sites in North America and Europe (up to 30%).
  • Proven marketing leader, excellent communications skills both written and verbal
  • Strong experience with Salesforce.com and Hubspot (or equivalent marketing automation Pardot, Marketo, etc.)
  • You must be analytical and comfortable developing and leveraging reports and dashboards to extract meaning from data and use to optimize programs and overall strategy
  • Must have the ability to pass a pre-employment background check
  • Position must be located TrialScope’s Jersey City, New Jersey corporate office with the ability to work from home office 65% of the time.

Skills

  • Proven track record of developing and managing a marketing team
  • Ability to instill esprit de corps both within team and across departments
  • Strong organizational skills, positive, responsive, and act with a sense of urgency
  • Desire to join a dynamic and growing company and thrive in a fast-paced environment
  • Very strong ability to communicate and gain consensus on marketing strategy and execute through departments within the organization
  • Work well under pressure and ability to meet ongoing and overlapping deadlines within short time constraints
  • Strong analytics skills and ability to leverage metrics to help drive effective product decision-making
  • Demonstrated ability to tactically execute and also play key role in strategic planning

To Apply

Please send your resume to jobs@trialscope.com