Manager, IRT Project

Job Description

• 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
• Responsible for providing end-to-end Interactive Response Technology (IRT) support to clinical project teams including but not limited to gathering study-specific IRT user requirements (e.g. study specifications, integration specifications, interim analysis data transfers etc.), managing and supporting UAT activities, monitoring system change requests
• Execute IRT development process from project kickoff to system go live, ongoing system change control, maintenance, and IRT system closeout.
• Ensure vendor system development processes align with Otsuka Quality Assurance requirements.
• Manage UAT activities including coordination of internal stakeholder and CRO participation and drafting UAT scenarios and performing testing as required.
• Monitor IRT system change requests. Works with the clinical project team to identify system changes and ensure completion of the changes through project life-cycle.
• Liaise with Clinical Supply Operations to ensure optimal and effective use of IRT medication management strategies.
• 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.

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Qualifications/ Required

Knowledge/ Experience and Skills:

• Minimum of 3 years of IRT Project Management experience or IRT database design & development
• Understanding of clinical supply chain within the pharmaceutical industry.
• 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 Project and PowerPoint
• Ability to work effectively in a multifunctional team environment.
• Travel (approximately 30%)

Educational Qualifications:

B.A./B.S. Degree in Biology, Life Sciences, Computer Science, or related field

Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.

Minimum $102,101.00 - Maximum $145,970.00, plus incentive opportunity: The range shown represents a typical pay range or starting salary for candidates hired to perform the work. Other elements may be used to determine actual salary such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. This information is provided to applicants in accordance with states and local laws.

Company benefits: comprehensive medical, dental, vision and prescription drug coverage, company provided Basic Life, AD&D, Short-term and Long-term Disability insurance, tuition reimbursement, a 401(k) match, PTO allotment each calendar year, paid holidays, and paid leave programs as well as other company provided benefits.

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 be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.   

 

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability.  You can request reasonable accommodations by contacting Accommodation Request. 

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Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities.  All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property.  No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

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