Sung Song

Clinical operations leader with 10+ years of total clinical research experience, including leading Phase I–IV trials across single-site studies, global trials, and sponsor-dedicated programs.

Experience includes early-development and oncology trials, cross-functional leadership, staff supervision and mentoring, study budgets and timelines, vendor oversight, risk mitigation, and inspection readiness. Holds an M.S. in Regulatory Affairs and an M.S. in Data Science focused on AI and machine learning.

AI Education and Professional Development - New York, NY

(2024-08 - 2026-09)

• Earned an M.S. in Data Science from Boston University, GPA 4.0, developing skills in AI, data analysis, and responsible AI use.
• Completed pharmacy technician certification through onsite training.

Senior Project Manager (promoted from Project Manager) - ICON - Remote, U.S.

(2022-09 - 2024-04)

• Earned promotion to Senior Project Manager based on consistent delivery.
• Led clinical studies across multiple therapeutic areas, including a Phase III GI study and a Phase II infectious disease study.
• Supported resource allocation and workload allocation, in addition to early-development strategy.
• Served as the point of contact for the Division President, Senior Executive Directors, Legal, Quality, and Finance.
• Managed five concurrent projects with oversight responsibility and inspection readiness activities.
• Directed project tasks supporting the maintenance stage for programs budgeted at more than $300 million.
• Oversaw global project management activities involving approximately 1,000 stakeholders.
• Led global, cross-functional project activities, maintaining alignment with client requirements, project scope, timelines, quality expectations, financial objectives, and inspection-readiness requirements.
• Strengthened inspection readiness across the program life cycle and incorporated risk-mitigation measures.
• Partnered with client counterparts to achieve project deliverables within required timelines.
• Contributed to a $200 million bid defense for an immunology drug.

Senior Project Manager - Real Staffing – dedicated to PPD - Remote, U.S.

(2021-08 - 2022-02)

contract via Real Staffing

• Led clinical trial activities in CNS, oncology, and ophthalmology.
• Directed closeout support for a program valued at more than $200 million, aligning risks, timelines, documentation, stakeholder needs, and audit and inspection readiness.
• Led startup and maintenance activities across 5 project teams, coordinating project priorities, documentation, and stakeholder follow-ups.
• Coordinated research documentation and finance personnel in preparation for a company-wide internal audit covering programs valued in the billions.
• Presented project updates to clients and executives throughout project delivery.
• Reconciled TMFs for closeout of a program.
• Mentored Project Associates and Project Managers to support clinical trial delivery and professional development.
• Oversaw vendors and reviewed ICFs and study plans.

Senior Clinical Trial Manager - Docs (ICON) – dedicated to Amgen - Remote, U.S.

(2021-02 - 2021-07)

• Led two high-priority studies: a Phase Ib oncology study in a patient population and a Phase III pediatric neuroscience study.
• Led country and regional study operations, coordinating cross-functional teams, resources, timelines, and issue resolution.
• Led cross-functional teams across all aspects of clinical trial delivery.
• Managed study budgets and vendors.
• Maintained continuous inspection readiness.
• Supervised and mentored junior staff supporting clinical trial delivery.
• Directed study maintenance and closeout activities.
• Identified and mitigated study risks.
• Reviewed and updated project timelines and milestones in MS Project.

Project Manager I - Syneos Health – dedicated to AbbVie - Remote, U.S.

(2020-02 - 2021-01)

• Led execution of a high-priority project for a drug-development program valued at more than $1 billion, meeting required timelines.
• Managed a Phase III immunology/dermatology study in accordance with SOPs, GCP, and ICH guidelines.
• Led vendor oversight, including selection of a patient-recruitment vendor.
• Delivered study startup and maintenance activities within the required timeline and budget.
• Maintained eTMF health throughout the study life cycle.
• Administered CTMS updates to keep records current.
• Developed the ICF in collaboration with the medical monitor and Legal.
• Planned the Virtual Investigator Meeting and developed presentation slides.
• Created training materials for sites and CRAs.
• Identified and mitigated study risks while maintaining inspection readiness.
• Reviewed protocols and amendments with cross-functional partners.
• Supported the development of clinical operations content for regulatory and ethics submissions and coordinated responses to IRB/EC and health authority questions with Regulatory Affairs and cross-functional partners.
• Coordinated global study activities with CRAs and served as the IRB contact.
• Oversaw EDC and IRT setup.

EDO SL/VLA – Clinical Vendor Operations Management - ExecuPharm (a Parexel company) – dedicated to Novartis - Remote, U.S.

(2018-04 - 2019-09)

• Served as a core member of the Clinical Trial Team.
• Supported Phase III cardiology studies, including endpoint-observation protocols, a pediatric study, and a bridging study in Japan, as well as startup for a Phase II orphan-disease study.
• Managed vendor activities across nine concurrent studies budgeted at more than $500 million in partnership with operations teams.
• Coordinated vendor and clinical operations activities across North America, Latin America, Europe, Asia-Pacific, and Africa, including a global study with more than 700 sites.
• Managed vendor activities from RFP and contracting through startup, maintenance, change orders, database lock, and study closeout.
• Oversaw activities for eCOA, central laboratory, IRT, imaging, CRO, digital patient-engagement, IMP transportation, and patient-transportation vendors.
• Led vendor meetings and supported Clinical Trial Team meetings.
• Performed UATs for IRT.
• Supported vendor budgets, invoice resolution, and eCOA end-of-study reconciliation.
• Coordinated clinical trial logistics, vendor selection, and contract negotiations.
• Monitored vendor KPIs, resolved performance issues, and coordinated corrective and preventive action (CAPA) activities with Quality Assurance and cross-functional stakeholders.

Clinical Trial Manager - Planet Pharma – dedicated to Allergan - Jersey City, NJ

(2016-08 - 2017-10)

contract via Planet Pharma

• Managed Phase II-IV studies in women’s health, infectious disease, and GI.
• Coordinated Phase II–IV trial activities with Regulatory Affairs, Clinical Planning, Quality, Legal, Global Drug Safety, and Study Startup.
• Oversaw global biosimilar development operational execution through oversight of cross-functional trial activities in partnership with the CRO.
• Ensured implementation of trials in accordance with applicable SOPs and ICH/GCP guidelines.
• Managed the day-to-day execution of clinical studies, including timelines, to ensure high-quality, on-time, and within-budget delivery.
• Contributed to the development, revision, and implementation of clinical operations SOPs, work instructions, and process improvements to support compliant study execution.
• Provided study-level oversight of site feasibility, startup, enrollment, site activities, and closeout activities through CRAs, CROs, and internal study teams; escalated site risks and performance issues as needed.
• Oversaw vendor payments and study budget components in accordance with contracts.
• Developed and maintained study-related documents, including study plans and monitoring plans.
• Served as the primary contact for assigned IRBs.
• Managed the eTMF and maintained inspection readiness across multiple studies.
• Coordinated clinical supplies, drug reconciliation, and drug destruction activities.
• Ensured forward and back translations of ICFs for local sites.
• Reviewed CRO communication and monitoring plans and managed the CRO for a GI study.
• Conducted UATs for eCOA/ePRO and IRT and supported these systems during startup and maintenance for U.S. and global studies.

Clinical Program Manager - Synectics – dedicated to Pfizer - New Haven, CT

(2016-02 - 2016-07)

contract via Synectics

• Managed Phase I studies at the Pfizer

M.S. - Data Science (focus in AI and Machine Learning) - Boston University (2026-05)

M.S. - Regulatory Affairs for Drugs, Biologics, and Medical Devices - Northeastern University

B.S. - Biological Sciences: Microbiology - University of Rochester