Posted to MedZilla on 11/11/2019

Takeda Pharmaceuticals

US-MA, Lead IRT & ePRO Operations Specialist SR0041719-MZ


Reports into Clinical Information Operations Team Lead. Provides leadership and expertise for CDO technology strategy and initiatives to address CDO business objectives. Responsible for defining and ensuring support is provided for Clinical Development Operations (CDO) systems. Ensures support for CDO sub functions as assigned (e.g. Biostatistics & Programming, Clinical Programs, Study teams, Document Management, Clinical Trial Transparency). Partners with key business users and IT to provide support for intended use of systems. Supports definition and implementation of business processes.

The Clinical Information Operations Lead will participate in, and provide business leadership for the following activities:

  • Implementation of new CDO systems or upgrades to existing systems. This person will ensure new, upgraded, or current CDO systems are supported and maintained, delivers intended functionality, appropriate business processes are developed, and that users are optimally trained.
  • Identification of new cost effective solutions to support the optimal delivery of clinical programs. Will work with business representatives, CROs, vendors and IT to ensure successful delivery of solutions.
  • Coordination and participation with external parties (Vendors and CROs) to ensure proper functioning and business support of identified CDO capabilities (e.g. data exchange, SAS, data warehouse, document exchange).
  • Day to day administration of systems, working with stakeholders to drive adoption, identify and resolve usability issues.

40% Delivering Excellence: Takes Leadership Roles in Projects and Project Implementations:

  • Represents CDO as technology SME s to recognize areas of potential opportunity, mitigate risks and provide solutions to identified problems.
  • Leads cross functional groups in identifying business requirements and technology capabilities to support clinical development needs.
  • Collaborates with business users and IT to identify and select technology solutions.
  • Ensures business user acceptance testing is conducted
  • Ensures training of staff to optimally use technologies.
  • Leads business resources to develop and deploy appropriate business processes to support technology solutions.
  • Acts as primary business project manager for technology projects.

Accountability and Ownership:

  • Leads in the deployment of technologies and business process across the CDO organization.
  • Acts as primary business change agent to ensure adoption of new capabilities and business process
  • Collaborates with leaders of supported business functions to identify and resolve issues impacting delivery of clinical trials
  • Leads collaboration with CROs and vendors to ensure services and business tasks are executed as per contract and SLAs

Judgment and Decision Making:

  • Evaluates immediate business impact and takes decisive action
  • Assesses technology planning for proposed changes, contingency plans and integration work streams.
  • Evaluates new technology deployment strategies and activities to ensure optimal benefit for CDO and Takeda.
  • Keeps current with industry developments and strategies related to clinical technologies.

35% Serving Customers:

  • Consults with supported business functions to identify gaps, risks, and inefficiencies.
  • Acts as expert resource (SME, PM) to ensure acquisition, deployment and operation of clinical technologies.

Building Authentic Relationships:

  • Leads in developing trust through transparency in communication and individual actions. Ensure outcomes are team driven and collaborative.
  • Coordinate with business functions to deliver technology related activities.

25% Leading and Managing:

  • Communicates clear and specific expectations to assigned staff members, CROs and vendors. Makes sure they are understood.
  • Seeks to accomplish critical tasks with measureable results.
  • Delegates appropriate tasks to staff members and contractors to maximize effectiveness of the organization. Gives support, direction, and follow-up without undermining delegated authority.
  • Uses appropriate methods and interpersonal styles to develop, motivate, and guide team to success.

Education and Experience Requirements:

  • Bachelor s degree or related experience is required.
  • Knowledge of drug development process.
  • 7+ years experience in Data Management, Programming, Clinical IT, or other Clinical Research related fields.
  • Understanding of industry standard technologies to support Clinical Development needs (e.g. CTMS, SAS, Data Warehouses, Sharepoint, etc.)

Key Skills, Abilities, and Competencies:

  • Demonstrated knowledge of drug development process.
  • Demonstrated knowledge of clinical technologies.
  • Strong attention to detail.
  • Ability to present complex technical issues to non-technical people.
  • Proven ability to manage staff and communicate effectively with internal and external personnel.
  • Demonstrated ability to lead teams and work groups.
  • Ability to work independently, takes initiative, and complete tasks and make deadlines.
  • Excellent verbal and written communication skills, ability to communicate effectively to multiple levels of the organization with strong negotiation skills.

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.

EEO is the Law -

EEO is the Law Supplement -

Pay Transparency Policy -

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.

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