Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Vaccine verification will be required.
POSITION SUMMARY:
The Senior Manager IT, Regulatory & Clinical Applications position, within the Information Technology & Services (IT&S) organization, is a hands-on role, responsible for the support and enhancement of Clinical Trail Management, Quality Management and other compliance solutions and services.
Responsibly includes the planning, development, and operation of business applications to support the organizational objectives of Clinical Trail Management System (CTMS), Quality Management System (QMS) and other compliance functions. The individual will work with other business stakeholders and IS&T leaders to translate the organization's business requirements into specific application projects and deliverables measures the effectiveness of the projects, and track progress against plan and operational Service Level Agreements (SLA). In addition, the individual will manage highly qualified, technical, and functional staff members focused on business systems, by providing the coaching and guidance to assist the team in fulfilling the business and technical objectives.
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The ideal candidate will represent the IS&T organization in interacting with senior-level leaders and third-party service providers and partners on matters that often requiring the coordination of activity across organizational lines to build and maintain robust and scalable enterprise business solutions.
PRIMARY RESPONSIBILITIES:
- Build, Own and deliver the roadmap definition, prioritization, support, and maintenance across global business applications portfolio of Clinical Trail Management, Quality Management, and other compliance business functions
- Collaborate and partner with business leaders and project managers in determining a plan for implementing enterprise business solutions, services & systems in supporting business needs
- Provide day to day leadership in the development of processes, solutions, and best practices for the business systems domain and project execution by applying technical and functional knowledge and skills
- Develop, maintain and support a complex portfolio of business systems projects
- Build an effective Software Release process in partnership with functional leaders to ensure maintenance and enhancement requests are delivered in compliance timely to support the business needs
- Partner closely with Data & Analytics team for building and operating Enterprise Data Warehouse, Big Data & BI platform for a high level of availability and high performance
- Participate in vendor evaluations, solutions, develop alternatives, leading fit-gap analysis and recommend technical solutions in meeting the evolving needs of the business
- Collaborate closely with IS&T validation, and corporate Regulatory groups to ensure the compliance and timely resolutions of issues.
- Provide management and leadership to a group of Business Systems Analyst (BSA) and functional team members including offshore partners
- Recruit, Hire, Build and Grow a team of customer-focused SaaS business application delivery.
- Motivate and lead teams for delivering the best possible business systems experience
- Deliver project management support and oversight for the SaaS Quality Management System (QMS), with the initial implementation, migration from the existing QMS system, and all other projects as needed by the business.
- Deliver project management support and oversight for the SaaS Clinical Trial Management System (CTMS) implementation
- Partner with stakeholders to develop and execute the implementation plan and drive projects.
- Ensure that all proper documentation for compliance is developed and delivered on time.
- Communicate system changes and issues to relevant stakeholders.
- Manage the delivery of any open defects, integration work, and/or requested enhancements post launch within the timeline established.
QUALIFICATIONS:
- Bachelor's degree in Computer Science, Engineering, or related discipline/experience. A Master's in computer science is a plus.
- 7+ years working in Information Technology, with at least 5+ years of experience leading and delivering complex enterprise business solutions
- 3 years of experience in Healthcare, Life Science or Pharmaceutical industry is required.
- Experience working in a complex environment; multiple sites, multiple global regions, multiple stakeholders (internal and external)
- Experience in delivering/leading projects of CTMS and QMS on SaaS platforms like Viva or Salesforce is required.
- Experience and working knowledge of CTMS, QMS is must. Hands on experience will be required.
- Experience working with ServiceNow, Jira, Confluence solutions is highly desirable.
- Exposure to managing in-house, outsourced, and SaaS-based applications and infrastructure. The candidate must have a deep understanding of the SaaS landscape and integration platforms.
- Demonstrated ability to lead and energize multidisciplinary, multi-site, and project teams using skilled communication and excellent interpersonal skills.
- Deep knowledge and understanding and analyzing of the end-to-end functional requirements.
- Skilled in interviewing business users and run workshops, collecting, and interpreting requirements, explaining the solution details to the business audience
- Strong familiarity with Project Planning tools, JIRA, Confluence and G-Suite.
KNOWLEDGE, SKILLS, AND ABILITIES:
- Excellent communication skills with the ability to convey information to internal and external stakeholders in a clear, focused, and concise manner
- Proven experience in managing projects and processes with ambitious milestones under pressure successfully
- Demonstrate high individual effectiveness and organization skills: flexibility, communication, time-management, and interpersonal skills, with high attention to detail, and experience handling multiple projects/tasks simultaneously while meeting deadlines.
- Previous experience in a regulated industry such as biotech, pharmaceuticals, or medical devices is highly desirable.
PHYSICAL DEMANDS & WORK ENVIRONMENT:
- Duties are typically performed in an office setting. 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.
- Travel required for this position: No
Driven by the passion for elevating the science and utility of genetic testing, Natera is committed to helping families identify and manage genetic diseases. Natera is a rapidly growing diagnostics company with proprietary bioinformatics and molecular technology for analyzing DNA. Our complex technology has been proven clinically and commercially in the prenatal testing space and we are actively researching its applications in the liquid biopsy space for developing products with oncology applications.
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 OFFER
Competitive Benefits. Healthy catered lunches, Premium snacks and beverages, Onsite gym with cardio and weight-training equipment, Game room with satellite TV, Onsite dry cleaning and alteration service with pick-up and delivery, Employee-organized sport leagues, Happy hours and BBQs, Generous Employee Referral program.
For more information, visit www.natera.com.
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.