Senior Manager Digital Enterprise Capabilities Clinical Systems Operations

Overview

• Lead digital enterprise capabilities for clinical systems operations in a dynamic biopharmaceutical organization, driving innovation and operational excellence.
• Enhance clinical trial processes through advanced digital solutions and system optimization strategies.
• Collaborate with cross-functional teams to align system performance with clinical business objectives and priorities.
• Ensure compliance with GxP standards and regulatory requirements, maintaining operational readiness and excellence.
• Promote continuous improvement in system documentation, validation processes, and operational efficiency.
• Contribute to product roadmaps and release planning, integrating technical feasibility with innovation strategies.
• Oversee vendor management, system performance monitoring, and contract oversight to achieve business goals.
• Facilitate operationalization of new systems, ensuring seamless transitions to steady-state support.

Key Responsibilities & Duties

• Collaborate with clinical capability owners to align digital systems with operational objectives and priorities.
• Oversee system release planning, change control, and validation activities to ensure compliance and efficiency.
• Maintain comprehensive system documentation, including validation packages, SOPs, and test scripts.
• Drive issue resolution and technology optimization in collaboration with vendors and product managers.
• Plan and execute core system ownership tasks, including user access reviews and disaster recovery testing.
• Manage smaller-scale projects, including scope definition, resource planning, and budget tracking.
• Ensure alignment with quality and compliance functions to uphold validation and operational standards.
• Provide input on system enhancement opportunities to support product road mapping and release planning.

Job Requirements

• Bachelor's degree in a relevant field or equivalent combination of education and experience.
• 5-7 years of experience in clinical systems operations, with expertise in GxP compliance and validation.
• Proficiency in clinical systems such as Medidata, Veeva Clinical, and eClinical Solutions.
• Strong vendor management skills, including contract oversight and performance monitoring.
• Experience with Agile methodologies and delivering SaaS-based or cloud-enabled solutions.
• Certified Veeva Clinical Operations Administrator is preferred.
• Excellent communication and collaboration skills to engage stakeholders across IT, Quality, and Clinical functions.
• Solid problem-solving and organizational skills, with attention to detail in regulated environments.