Capability Development Specialist

This is a fully remote position, open to applicants in India.

📋 Description

• Collaborate with GDO, R&D, and cross-functional stakeholders to gather requirements and achieve consensus on trial data capabilities as outlined in the Trial Data Delivery Strategy.

• Develop and sustain collaborative working relationships with BPO/PEL and data initiative leaders to fulfill functional priorities within the trial data roadmap.

• Provide leadership to enhance trial data maturity and ensure high standards of data quality.

• Define functional capabilities for trial data in alignment with GDO's business and strategic objectives.

• Guide stakeholders in prioritizing requirements and ensure that the overall solution meets or surpasses customer expectations.

• Implement and integrate changes and requirements of varying sizes in project data delivery.

• Employ analytical methods and independent judgment to pinpoint and prioritize opportunities for streamlining business processes.

• Adhere to company and departmental policies, procedures, documentation, Takeda QMS, Software Development Life Cycle, and Project Life Cycle standards.

• Work autonomously with stakeholders to prioritize requirements and serve as a primary resource for complex issues.

• Establish connections throughout Takeda, analyze challenges, and facilitate solution development.

• Cultivate and maintain relationships with key business stakeholders.

⛳️ Requirements

• Preferred Bachelor's Degree or international equivalent.

• Advanced degree is preferred.

• A minimum of 5 years of experience in business analysis, data analysis, data transfer, or data model roles, or over 6 years of relevant experience in lieu of a Bachelor’s degree or international equivalent.

• At least 3 years of experience in life sciences is preferred, with a background in clinical trial management or operations being advantageous.

• Advanced understanding of the pharmaceutical industry, specifically in clinical trial operations and trial management.

• Familiarity with GXP requirements, including 21CFR part 11 and validation methodologies.

• Proven ability to identify opportunities and foresee changes in the business landscape through continuous assessment of the data environment impacting the business.

• Experience in communicating and presenting to cross-functional audiences.

• Demonstrated capability to effectively collaborate cross-functionally within a highly matrixed organization.

• Legal authorization to work in the country where the role is based.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.

• Benefits may vary based on role and location.