POSITION SUMMARY:

The Senior Clinical Trials Systems Manager oversees the implementation, maintenance, and optimization of clinical information systems, such as CTMS, eTMF, and Clinical Trial Investigator Portal. This role ensures the integration of clinical systems with the organization's operational workflow and enhances user experience through staff training, continuous system improvements, and troubleshooting. This individual collaborates with cross-functional teams (clinical trials, data management, QA, IS&T, and vendors) to drive design, configuration, integration, and deployment of new systems and enhancement. The Manager of Clinical Systems ensures adherence to requirements of study protocols, industry standards, regulatory, business objectives, and user needs. 

PRIMARY RESPONSIBILITIES:

• Lead cross-functional teams through thoughtful planning, design, configuration and deployment of new clinical systems and enhancements to existing applications.
• Accountable for the development and maintenance of the department’s systems strategy and roadmap, in partnership with ClinOps Leadership.
• Ensure system compliance with regulatory standards (e.g. FDA, EMA, ICH-GCP).
• Oversee project timelines and associated activities to ensure deliverables are met (cross-functional meetings, stakeholder alignment, requirements gathering, release plans).
• Partner with IS&T, QA, and CinOps stakeholders on system integrations and upgrades, and to confirm vendor compliance against contracted services.
• Establish and enforce Standard Operating Procedures (SOPs) and guidelines related to the management and use of clinical systems.
• Oversee the gathering of stakeholder requirements, ensure they are understood, identify gaps, and design system enhancements.
• Serve as point of contact for internal teams, address concerns and provide technical and functional support.
• Act as a change agent to ensure minimal organizational disruption during implementations.
• Provide user training for clinical systems, during deployments and on an ongoing basis.
• Liaise with system vendors to establish optimum performance and escalate issues as needed.
• Lead review of vendor quarterly system updates, present proposals of enhancements to deploy.
• Must complete training related to HIPAA/PHI privacy, General Policies, Procedure Compliance, and security as soon as possible but not later than the first 30 days of hire.
• Performs other duties as assigned

QUALIFICATIONS:

• Bachelor’s Degree in a related field of study or equivalent, PMP certification preferred.
• 8+ years of biotech-related/clinical research experience with a background in information management in an end user computing environment. 
• Experience working in Clinical Systems (eTMF, CTMS, etc.).
• Experience with Salesforce Administration is preferred.
• Experience leading people to achieve aggressive timelines with high quality.
• Proven record of working effectively with and across business areas (clinical science, quality assurance, data management, regulatory, legal, business development, etc.).

KNOWLEDGE, SKILLS, AND ABILITIES:

• Understands Clinical Operations business processes and roles.
• Makes independent decisions pertaining to day-to-day responsibilities and assigned projects.
• Keeps leadership apprised of business-critical risks and proactively proposes solutions.
• Requires ability to change the thinking of, or gain acceptance from others in sensitive situations without damage to relationships.
• Provides feedback to management, respectfully and intentionally, in order to achieve departmental and corporate goals and deliverables.
• Has frequent contact with external parties and is viewed as a respected representative of Natera.
• Detail oriented, with solid organization, planning, and time management skills.
• Ability to manage multiple projects and priorities in a fast-paced environment.
• Strong customer focus.

PHYSICAL DEMANDS & WORK ENVIRONMENT:

• This position requires the ability to use a computer keyboard, communicate over the telephone and read printed material. 

Duties may require working outside normal working hours (evenings and weekends) at times.