Capability Development Specialist

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

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

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

Visit our to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request.

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