Tara Wamil
@tarawamil
Associate Director in Clinical Operations, leading global Phase I–IV trial execution and inspection readiness across rare disease and oncology.
What I'm looking for
I’m an Associate Director / Clinical Operations Program Lead with extensive global clinical trial leadership across Phase I–IV, including rare disease and oncology programs. I lead international studies from startup through database lock readiness—driving operational strategy, timeline management, risk mitigation, and inspection preparedness across North America, Europe, APAC, and the Middle East.
I partner cross-functionally to support regulatory submission planning and program milestones, overseeing CROs, vendors, and global clinical operations activities in Japan and Saudi Arabia. I own inspection readiness and quality execution—covering CAPA development, TMF health assessments, audit trail reviews, protocol deviation oversight, and mock inspections—while also managing operational risks (drug supply, enrollment, customs/importation, and regional regulatory requirements) and program budgets from forecasting through variance analysis.
Experience
Work history, roles, and key accomplishments
Serves as Clinical Operations Program Lead for global Phase III/IV rare disease programs across North America, Europe, APAC, and the Middle East. Leads startup-to-database-lock execution, CRO/vendor oversight, risk mitigation, and inspection preparedness.
Provided Clinical Operations Program Lead support for global rare disease clinical studies. Managed operational strategy and inspection preparedness while coordinating cross-functional issue resolution.
Senior Clinical Trial Manager (LSM)
Mar 2024 - Nov 2025 (1 year 8 months)
Served as a Lead Study Manager supporting complex international clinical execution from operational planning through database lock readiness. Coordinated data quality activities and cross-functional reviews to support timely study deliverables.
Managed Lead Study Manager responsibilities for global clinical trials, supporting operational execution and inspection readiness. Drove documentation and process alignment across clinical operations stakeholders.
Clinical Operations Program Lead
CTA-CTS
Aug 2021 - Feb 2023 (1 year 6 months)
Provided Clinical Operations Program Lead support for global clinical studies across regulated regions including Japan and Saudi Arabia. Supported inspection readiness activities with CAPA development, TMF health assessments, and audit support.
Set up, maintained, and closed project files and study information across regulatory documents and Trial Master File (TMF) content. Supported inspection readiness through TMF review, quality checks, gap analysis, and real-time document retrieval.
Sr. Project Specialist
Clinical Trial Advisors, LLC
Nov 2018 - Nov 2020 (2 years)
Prepared meeting agendas/minutes and supported study documentation and executive progress reporting. Contributed to inspection readiness with TMF reviews and tracked protocol deviations, data queries, and CAPAs aligned with GCP/ICH and regulatory requirements.
Senior Recruiter
Metro Team Resources
Apr 2018 - Nov 2018 (7 months)
Recruited for direct-hire and contract roles by building qualified candidate pipelines and managing an applicant tracking process. Sourced and screened candidates, supported interviews, and coordinated with hiring managers to match skill sets to job requirements.
Recruiter
Matlen Silver
Dec 2017 - Apr 2018 (4 months)
Led full-life-cycle recruiting for consultants and FTE placements across Fortune 500 clients, including scheduling, rate negotiation, and reference checking. Managed independent contractors and supported candidate travel coordination while maintaining pipeline communications in an applicant tracking system.
Team Leader
Moody’s Analytics
Oct 2015 - May 2017 (1 year 7 months)
Managed team hiring and onboarding activities, including candidate screening, preliminary interviews, and training on internal systems and research methods. Supported team evaluations and prepared commercial real estate forecasts based on collected property data and primary/independent research.
HR & Recruitment Oversight
Pure Digital Co.
Apr 2015 - Oct 2015 (6 months)
Created and managed job postings, recruited new talent, and supported candidates through the hiring process. Provided payroll and benefits enrollment support (ADP) and onboarded employees while following HR best practices.
Education
Degrees, certifications, and relevant coursework
Fordham University
Bachelor of Science, Psychology
Activities and societies: Dean’s List; Dean’s Achievement Award.
Earned a Bachelor of Science in Psychology at Fordham University, recognized on the Dean’s List and receiving the Dean’s Achievement Award.
Availability
Location
Authorized to work in
Job categories
Skills
Interested in hiring Tara?
You can contact Tara and 90k+ other talented remote workers on Himalayas.
Message TaraFind your dream job
Sign up now and join over 100,000 remote workers who receive personalized job alerts, curated job matches, and more for free!
