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Role Description

The position is responsible and accountable for managing activities related to business and operations processes and systems utilized by the Functional Unit. This position may include oversight of the relationship with vendors within the Functional Unit, leading the creation of the annual plan and objectives in collaboration with senior leaders and responsible to oversee successful execution and delivery and/or ensuring Functional Unit is inspection ready at all times and that procedures, training and inspection readiness activities are being actively supported and managed across Functional Unit.

• Contributes to the strategic direction of the clinical systems team including support of new technology deployment, enhancements and establishing data quality standards/oversight.
• Ensures successful execution of training to functional team members on clinical systems and processes.
• Identify new technology needs, support budget evaluation and business case development to launch technologies for the Functional Unit.
• Work cross functionally to represent the technology needs for clinical trial operational execution.
• Contributes to all eTMF processes including systems management, TMF migrations, document management processes, TMF compliance processes, archival processes and liaison with records and information management teams and regulatory authorities.
• Supports all aspects of operational and process standards to ensure effective implementation, adaptation of process, oversight of process efficiency and identification of issues and risks.
• Engages cross functional teams as needed to ensure efficiency and quality of vendor performance against Astellas expectations.

Qualifications

• Bachelor’s Degree required; MS degree preferred
• Minimum 7 years of relevant work experience required
• At least 5 years of pharmaceutical industry experience and good understanding of responsibilities and processes in one or more DS functional areas
• Portfolio planning, forecasting, and budgeting skills and experience
• Quality, compliance and/or inspection/audit experience
• Familiarity with PM methodology preferred
• Expert knowledge with clinical trial operational data and applications (i.e. Vault Clinical), including strategy
• Prior experience with UAT testing, UAT test scripts, and preparing UAT data
• Prior experience with enterprise system implementation or major enhancement build out
• Prior experience as a business process owner or administrator of clinical operations systems
• Prior experience with business requirements specification documents

Requirements

• Highly preferred to have experience with data governance – application or enterprise
• Highly preferred on data flows from CRO data integrations – Milestones, reference data, or site data (organizations, locations, persons)
• Highly preferred to have admin level support in operational applications
• Highly preferred to have previous contributions to System Lifecycle Management process and documentation
• Highly preferred to have experience with authoring job aids and business process documents
• Highly preferred to have experience with measuring and managing data quality metrics and compliance
• Preferred to have experience as a user or implementation of portfolio and project management systems
• Preferred to have experience with development or specifications for dashboards, reports
• Preferred to have experience as a user or implementation with site training solution
• Preferred to have prior experience with a clinical trial execution role (clinical trial lead or manager, clinical research lead or manager)
• Preferred to have prior experience implementing AI use cases for clinical trials

Benefits

• Medical, Dental and Vision Insurance
• Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
• 401(k) match and annual company contribution
• Company paid life insurance
• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
• Long Term Incentive Plan for eligible positions
• Company fleet vehicle for eligible positions
• Referral bonus program