Sr. Technical Program Manager

The Role

The Clinical Operation and Pharmacovigilance Senior Technical Program Manager will report to and work closely with the Sr Director, Digital  Clinical Operation and Pharmacovigilance 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 and Pharmacovigilance. 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 and PV 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 and Pharmacovigilance.

• 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 and Pharmacovigilance 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 (CTMS, eTMF, data integration, RBQM) and PV systems (ARGUS, PSMF) 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.

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 volunt