The Role

The Clinical Operation Senior Technical Program Manager will report to and work closely with the Sr Director, Digital Clinical Operation to ensure the implementation of new solutions and improvement of existing systems for the Moderna Clinical Development Organization (CDO). This role will help shape and deliver the long-term strategic vision for the Clinical Development Organization spanning across Clinical Operations. This opportunity is unique in the pace and speed we expect and achieve.

Here’s What You’ll Do

• Lead Projects to improve functional, technical, configuration and development for the Digital landscape supporting the CDO organization

• Act as the Sr Technical Project Manager for the Clinical systems and integration with external sources and/or systems.

• Manage fast-phase projects and deliver results as expected.

• Provide leadership and architectural knowledge within large cross functional projects

• Propose, Lead and deploy small and medium-size continuous improvement projects within Clinical Operations.

• Independently deliver projects and initiatives in a timely and qualitative manner

• Highlight potential risks and act proactively to resolve issues

• Participate in the demand management process to assist the business in establishing business cases relating to new systems or potential system changes

• Work independently to author System Configuration Specification, System Administration SOP, execute test scripts following GxP.

• Author, review and approve lifecycle documents like Impact assessment, Regulatory applicability, and criticality assessments, ERES assessments etc.

• Work with Clinical teams to define and implement integrations across systems

• Assists in evaluation or product enhancements and capabilities, implementing upgrades as required.

• Support initial and routine upgrade system risk assessment and testing activities

• Additional duties as may be assigned from time to time

Here’s What You’ll Need (Minimum Qualifications)

• A bachelor’s degree in STEM or another relevant academic discipline required.

• A minimum 10 years of industry experience implementing and maintaining laboratory systems.

• Must have 5 years of experience working with Clinical Systems (CTMS, eTMF, data integration, RBQM) and Application Integration.

• Must have hands on experience working with the above systems.

• Experience authoring and reviewing computer system validation lifecycle documents.

• Working understanding of GCP regulations.

• Strong communication skills (verbal and written). 

• Demonstrated ability to work independently and collaboratively in cross-functional teams.

• Compliance focused mindset

Here’s What You’ll Bring to the Table (Preferred Qualifications)

• Working understanding of GCP practices

• An understanding of computer systems validation practices (GAMP)

• Strong communication skills (verbal and written)

• Demonstrated ability to work independently and collaboratively on cross-functional teams

• Experience working in a matrixed environment

• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

Under Washington State law, Moderna is required to provide a reasonable estimate of the salary range for the jobs covered by this description. Base compensation for these positions in Washington State range from $144,000 to 230,500. Actual salary determinations will take into account factors such as work location, prior education and experience, job-related knowledge, and demonstrated skills. Compensation decisions are made on the facts and circumstances of each case.

In addition to base compensation Moderna employees are eligible for a comprehensive incentive compensation package including an annual cash bonus, new hire equity and an annual refresh, 401(k) match, competitive and inclusive medical, dental, and vision coverage options, flexible spending accounts for medical and dependent care, Life, LTD, and STD insurance, family leave offerings, including at least 18 weeks of 100% paid parental leave, lifestyle spending account, adoption, surrogacy, and family-planning benefits, generous paid time off, including:

• Vacation, sick time, and observed Company-wide holidays

• Paid volunteer time to participate within your community

• Discretionary winter holiday shut down

• Paid 4-week sabbatical after 5 years, and every 3 years after

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes 
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ community
• Generous paid time off, including:
  • Vacation, sick time and holidays
  • Volunteer time to participate within your community
  • Discretionary year-end shutdown• Paid sabbatical after 5 years; every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes
• Location-specific perks and extras!

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. 

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer) 

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