Sr Clinical Trials Systems Manager

Company: Tbwa Chiat/Day Inc
Location: San Carlos
Posted on: January 16, 2025

Job Description:

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 ClinOps 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.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.The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations.$150,000 - $175,000 USDOUR OPPORTUNITYNatera is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women's health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you'll work hard and grow quickly. Working alongside the elite of the industry, you'll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.WHAT WE OFFERCompetitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program!Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.If you are based in California, we encourage you to read this important information for California residents.Please be advised that Natera will reach out to candidates with a @natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.
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Keywords: Tbwa Chiat/Day Inc, San Jose , Sr Clinical Trials Systems Manager, Executive , San Carlos, California