Senior Manager Digital Enterprise Capabilities Clinical Systems Operations

Overview

• Lead clinical systems operations within a global biopharmaceutical organization, driving innovation and compliance in digital solutions supporting clinical development processes.
• Collaborate with cross-functional teams to manage system lifecycle, ensuring optimal performance and alignment with clinical business priorities.
• Enhance clinical trial planning, execution, and data analysis through advanced digital solutions and strategic system management.
• Ensure adherence to GxP standards and regulatory requirements, maintaining operational excellence and inspection readiness.
• Drive vendor management, system performance monitoring, and contract oversight to optimize service delivery and achieve business goals.
• Contribute to product roadmaps and release planning, aligning technical feasibility with clinical priorities and innovation strategies.
• Facilitate operationalization of new systems, ensuring seamless transitions to steady-state support and operational efficiency.
• Promote continuous improvement in documentation and validation processes for clinical systems, ensuring compliance and operational excellence.

Key Responsibilities & Duties

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

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 computer systems 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, with ability to engage stakeholders across IT, Quality, and Clinical functions.
• Solid problem-solving and organizational skills, with attention to detail and ability to work in regulated environments.