Capability Development Specialist

Capability Development Specialist - Takeda - India

ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

OBJECTIVES/PURPOSE

• Work with GDO, R&D and cross-functional stakeholders to elicit requirements and gain alignment for trial data capabilities as defined by the Trial Data Delivery Strategy
• Build, develop and maintain highly collaborative and effective working relationships with the BPO/PEL and data initiative leads to ensure functional priorities in the trial data roadmap are delivered successfully
• Provide leadership to the organization's efforts to advance trial data maturity and excellence in data quality
  
  

Accountabilities

• Accountable for the definition of functional capabilities for trial data capabilities in alignment with GDO business and strategic priorities
• Advise stakeholders to prioritize requirements and to ensure the total solution delivered to the customer meets/exceeds expectations
• Execute and integrate small to large-scale changes and requirements in the data delivery of projects
• Use sophisticated analytical approaches and independent judgment to proactively identify and assist in prioritizing opportunities to streamline business processes
• Follow company and departmental policies, procedures and ensure documentation according to the Takeda Quality Management Systems (QMS), Software Development Life Cycle and Project Life Cycle standards
• Work independently with stakeholders to prioritize requirements and act as a primary resource on complex issues within a clear framework of accountability
• Establish relationships with colleagues across Takeda and analyze issues and guide the development of solutions within ongoing processes
• Build and maintain relationships with key business stakeholders
  
  

Education, Behavioural Competencies And Skills

Bachelor's Degree or international equivalent preferred, advanced degree preferred

• 5+ years of experience in business analysis, data analysis, data transfer, data model roles or 6+ years relevant experience in lieu of bachelor's degree or international equivalent
• 3+ years of experience in the life sciences preferred, with experience in clinical trial management/operations preferred
• Advanced understanding of the pharmaceutical industry, particularly clinical trial operations and trial management
• Understanding of GXP requirements, including 21CFR part 11 and validation methodologies
• Demonstrated skills to identify opportunities and anticipate changes in the business landscape through an understanding and ongoing assessment of the data environment affecting the business.
• Experience with communication and presentation to cross-functional audiences.
• Demonstrated ability to effectively work cross-functionally within a highly matrixed organization
  
  

What ICON Can Offer You

Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our Benefits Examples Include

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family's needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
  
  

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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 let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements We would encourage you to apply regardless – there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.

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