Senior Associate, IRT Project Manager
Otsuka Pharmaceutical

Princeton, New Jersey

This job has expired.

Position Summary

Responsible for providing end-to-end Interactive Response Technology (IRT) support to IRT Project Manager and to clinical project teams including but not limited to gathering study specific IRT user requirements, managing and maintaining study-specific ePlatform related timelines, supporting UAT activities, monitoring system change requests, and supporting training & education for stakeholders.

Key Job Responsibilities

  • Assist the IRT PM in executing IRT development process from project kickoff to system go live, ongoing system change control, maintenance, and system closeout while overseeing adherence to study-specific timelines
  • Support UAT activities including coordination of internal stakeholder and CRO participation, drafting UAT scenarios and performing testing as required.
  • Oversee vendor performance and relationship(s) at the clinical study level. Responsibilities may include performing root cause analysis and identifying corrective/preventative actions, and serving as a point of escalation for vendor issues.
  • Ensure vendor system development processes align with Otsuka Quality Assurance requirements.
  • Monitor system change requests. Works with the clinical project team to identify system changes and ensure completion of the changes through project life-cycle. Monitors and analyzes system change requests, and identifies corrective actions for utilization of standards.
  • Provide IRT support in the following areas:
    • Data transfer issue resolution between IRT vendors and internal/external systems.
    • Development/maintenance of relevant documentation, including applicable SOPs, job aids, and guidance documents.
    • Process improvement activities.
    • Training and education for stakeholders including development of training material.

Knowledge, Skills, Competencies, Education, and Experience

  • Minimum of 3 years of IRT Project Management experience or IRT database design & development
  • B.A./B.S. in biology, life sciences, computer science, or related field
  • Knowledge of databases, structure, & corresponding tools used to manage, extract, & report data.
  • Working knowledge of clinical research and statistical concepts.
  • Excellent Interpersonal and communication skills
  • Strong problem solving, planning, and organizational skills
  • Ability to set and communicate goals and job standards.
  • Strong detail-oriented, decision-making, negotiation, and multi-tasking skills
  • Experience with e-mail, Windows, word-processing, database, spreadsheet applications) as well as Microsoft PowerPoint
  • Ability to work effectively in a multifunctional team environment.

Physical Demands and Work Environment

Travel (approximately _10_%)

Come discover more about Otsuka and our benefit offerings;


This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.

Valid Proof of COVID-19 Vaccination or Accommodation

The COVID-19 Vaccination is mandatory for incoming new hires and employees. Uploading documentation with proof of full vaccination record or an Otsuka approved accommodation will be required during the pre-employment process as permitted by law. New hires must be fully vaccinated unless there is an approved accommodation prior to start date.

Statement Regarding Job Recruiting Fraud Scams

At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.

Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.

Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.

To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website

Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at:, or your local authorities.

This job has expired.

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