Senior Technical Program Manager, Clinical Development

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 yo