Clinical Trial Program Manager

About the role

The Technical Program Manager will lead end-to-end program management for clinical trial data initiatives, ensuring successful delivery against timelines and milestones. They will manage the clinical data lifecycle, identify program risks, and communicate status to both technical and executive stakeholders.

Responsibilities

• Lead end-to-end program management for clinical trial data initiatives, ensuring successful delivery against timelines and milestones.
• Manage the clinical data lifecycle from raw/source data through cleaning, validation, standardization, and FDA submission-ready outputs.
• Identify program risks, gaps, and dependencies, driving proactive solutions to keep projects on track.
• Partner directly with client stakeholders, engineering teams, and clinical experts to ensure alignment and successful execution.
• Manage workstreams, tasks, and project tracking using Asana.
• Cook up cross-functional teams across clinical, technical, and vendor organizations.
• Build and improve program processes, documentation, and standard operating procedures (SOPs).
• Communicate program status, risks, and recommendations to both technical and executive stakeholders.

Requirements

• Proven experience managing clinical trial programs from initiation through FDA submission.
• Strong understanding of the clinical trial data lifecycle, including raw data, data cleaning, validation, CDISC, SDTM, ADaM, and FDA submission processes.
• Hands-on experience working within FDA-regulated clinical trial environments.
• Demonstrated experience managing complex programs using Asana.
• Strong client-facing communication and stakeholder management skills.
• Ability to work independently, prioritize competing initiatives, and thrive in fast-paced environments.
• Proven track record of driving programs with minimal oversight and delivering results.

Qualifications

• Experience with AI/ML-enabled healthcare or clinical data platforms.
• Experience supporting regulatory submissions and FDA inspections.
• Knowledge of clinical data standards, statistical programming workflows, and submission packages.
• Experience working within consulting organizations or embedded client delivery teams.

Skills

• Strong leadership and project management skills.
• Excellent communication and stakeholder management abilities.
• Experience with clinical data lifecycle and FDA regulations.
• Proficiency in Asana and other project management tools.
• Ability to work in a fast-paced, dynamic environment.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• 401(k) retirement plan
• Long-term disability insurance
• Short-term disability insurance
• Personal days accrued each calendar year
• Paid time off meeting the paid sick and safe time laws
• 12-15 days of paid vacation time
• 6-8 weeks of paid parental leave after a year of service
• 9 paid holidays and 2 floating holidays per calendar year
• Ascendion Learning Management System
• Tuition Reimbursement Program