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Lead IRT / ePRO Operations Specialist

Boston, Massachusetts


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Lead IRT / ePRO Operations Specialist

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Job ID SR0054510 Date posted 10/19/2020 Location Boston, Massachusetts

Delivering Excellence: Takes leadership role in IRT and EPRO project implementation

  • Leads both internally within GCDO and externally across functions and service providers to study specific IRT and/or EPRO technology deployment and management strategies
  • Participates and collaborates with key process partners (e.g. Clinical Supplies, Biostatistics, Vendor Management, Procurement) in the sourcing, evaluation and audit/qualification of IRT and EPRO vendors
  • Collaborates with GCDO Training & Communications group to define and maintain a training strategy for technologies. 
  • Acts as the GCDO organization IRT expert and project manager for study deployment projects
  • Leads study teams in development of study specific user requirements specifications documents, user acceptance testing (UAT) protocols, and leads UAT execution. Ensures Good Documentation Practices are followed.
  • Provides support to study teams to resolve IRT issues during the conduct of the study
  • Collaborates with study team during the protocol development process to understand requirements for IRT technologies

Accountability and Ownership: Drives accountability at every possible level

  • Effectively manages operational delivery with IRT service providers; collects issues and trends from study teams; proactively works with Vendor Management and IRT vendors for issue resolution and prevention.
  • Collaborates internally and with IRT service providers to implement standards on both system design and data reporting.
  • Leads internal staff and external vendors to ensure availability and delivery of training programs to affected internal staff
  • Collaborates with and support other teams to identify best ways to streamline data flow between IRT and other GCDO systems (e.g. CTMS, Data Warehouse, Clinical Gateway, Clinical Supplies Management System).

Building Authentic Relationships: Building trusting relationships that will enhance current and future needs

  • Ensures trust through transparency in communication and individual actions; ensures outcomes are organizationally driven rather than individually driven; promotes collaborative organizational success.
  • In coordination with GCDO Vendor Management, Clinical Supplies, Biostatistics & Programming and Clinical Programs,  develops strategies to prioritize and deliver IRT related initiatives
  • Directs activities of IRT vendors – ensuring compliance with specifications, oversight of timelines and budgets

Judgment and Decision Making: evaluates immediate business impact and takes decisive action

  • Coordinates Shire evaluation and impact assessment of changes in the IRT landscape and ensures development of recommendations for actions
  • Provides support to teams on audit related issues for IRT services.
  • Ensures audit and inspection observations are evaluated and remediated in conjunction with the study team. Provides guidance and training to internal team members when needed.
  • B.S. degree in Scientific or related field is preferred.
  • Minimum  4 years in Clinical Research or Technology related role
  • Experience with technology evaluation, deployment and project management.

Knowledge and experience with IRT systems required.

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

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Reasonable Accommodations

Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

Job ID SR0054510

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