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
Knowledge, Skills, Competencies, Education, and ExperienceRequired:
- 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.
Physical Demands and Work Environment
- 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.
Travel (approximately _10_%)
Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.Disclaimer:
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
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