Clinical Trial Manager

Clinical Trial Manager — Meridian Clinical Development

Boston, MA | January 2024 – Present

• Led operational execution of 3 concurrent Phase II and III oncology trials across 18 clinical sites with $6.2M in cumulative budgets, achieving all milestones 20 days ahead of schedule.
• Negotiated service level agreements with 4 key CRO vendors, saving $140,000 in monitoring costs over 18 months while maintaining study quality standards.
• Implemented automated patient pre-screening tracking tools within Veeva Vault, increasing active patient enrollment rates by 28% across all global sites.
• Coordinated pre-audit site readiness evaluations for an FDA inspection, remediating 120 investigator site files and achieving zero critical findings.
• Supervised a team of 4 Clinical Research Associates (CRAs), decreasing monitoring report submission latency by 35% through structured standard operating procedures (SOPs).

Senior Clinical Research Associate — Beacon Clinical CRO

Boston, MA | August 2020 – December 2023

• Monitored site operations and protocol adherence for 4 multi-center Phase II immunology trials with 120 active participants across 8 regional centers.
• Audited 450+ electronic case report forms (eCRFs) in Medidata Rave, identifying and resolving 92% of queries prior to database lock to ensure data integrity.
• Conducted 35 onsite investigator monitoring visits (SIVs, IMVs, COVs), reducing protocol deviation rates by 30% through targeted GCP site training.
• Managed regulatory documentation and safety reporting for serious adverse events (SAEs), achieving a 100% on-time submission rate within the 24-hour window.

Clinical trial management, Good Clinical Practice (GCP), FDA regulations (21 CFR Part 11), ICH-GCP guidelines, CRO oversight, Site monitoring (SIV/IMV/COV), Veeva Vault CTMS, Medidata Rave, REDCap, Serious Adverse Event (SAE) reporting, Informed consent process, Protocol development, Budget forecasting, IRB submissions, MS Project, Resource allocation

Oncology Trial Acceleration Initiative

Role: Clinical Trial Manager

Tools: Veeva Vault CTMS, MS Project, Medidata Rave

Managed the startup phase of a 12-site Phase II oncology trial, reducing time-to-first-patient-in (FPID) by 24 days and reducing budget variance to less than 3%.

eTMF System Migration

Role: Lead CRA Coordinator

Tools: Veeva Vault eTMF, SharePoint, Excel

Led the migration of 8 active study investigator site files to Veeva Vault eTMF, organizing 1,200+ regulatory documents with zero data loss.

• Project Management Professional (PMP) — Project Management Institute (PMI) (2024)
• Certified Clinical Research Associate (CCRA) — Association of Clinical Research Professionals (ACRP) (2022)
• Good Clinical Practice (GCP) — CITI Program (2020)

• Languages: English (Native), Spanish (Professional working proficiency)
• Volunteer Work: First-aid support volunteer for the Red Cross Boston Chapter (2021-present)
• Availability: Standard 2-week notice period