Daniel Bustillo Email & Phone Number

Lead a PM group that has achieved the highest Customer Satisfaction ratings in the company everyyear since 2018.Responsible for developing and delivering to annual departmental budget.Lead a team of 5 PMs that support an average of 50 full-service studies.Resolve customer issues as the main escalation point for all studies.Manage and mentor 8 direct reports.Oversight of site operations on weekends as part of manager-on-call rotation.Represent PM function on the Executive Site Leadership Team (PM, HR, QA, and Site Head).Lead, or participate, in multiple process-improvement work streams.Help develop bids. Provide operational insight on bid defenses.Create and deliver operational and financial reports to senior management and site staff.

Miami, Florida

Successful delivery of over 35 Phase 1 studies, maintaining the highest average customer satisfaction scores among my peers. Primary contact with the Sponsor from project initiation to operational close out, often after participating in bid defense. Lead cross-functional project teams that include formulation development, manufacture, regulatory, recruitment, clinical conduct, data sciences, finance, pharmacovigilance, and third-party vendors.Supervise clinical activities during dosing days and weekends.

Miami, Florida

Responsibilities as above but with progressively increasing workload and project complexity.

Miami/Fort Lauderdale Area

Manager of Phase 2 and Phase 3 clinical trials. Leader of a complex, rescue, adaptive-design Phase 2/3 post-op study in the US. • Ensured the study progressed according to internal and Sponsor quality standards, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and International Conference on Harmonization (ICH) guidelines to fulfill all federal and local regulations. • Managed the executed contract and financial aspects of assigned projects, including reviewing study budgets and expenses, vendor management, and investigative site payments. • Led and mentored a large, geographically distributed team across various functional areas including clinical, data management, medical writing, biostatistics, QA, PK, PV, recruitment, finance, and regulatory.

Miami

Manager of Phase 3 clinical trials. Directed two multinational Phase 3 pivotal trials conducted in North America and Europe. • Developed and adhered to project plans, work breakdown structure, project schedule and financial models by organizing and leading resources throughout several countries.• Coordinated IRB/ EC and regulatory submissions in Europe and the US. • Spearheaded Biorasi´s initial expansion of clinical operations into Germany and Spain. • Assisted business development with bid grids, bid defense materials, site feasibility, vendor feasibility and management.

Miami Beach

Administered over an online advertising network serving several billion daily impressions, overseeing major accounts, software development, billing, and business development. • Led in-house and offshore production teams, leveraging SCRUM and agile management methodologies to direct a 24-hour production cycle. • Drove revenue for web publishers and online marketers by brokering partnerships and implementing creative media-buying and optimization strategies.

Coral Gables, Fl

Led department of forty translators and ten project managers to deliver over 8,000 annual projects in over 100 languages. • Increased department output, revenue, and profit margin each year from 2007-2010. • Modernized operations via the company-wide implementation of project-management and CRM software suites. • Oversaw implementation and continuous audit compliance of IS0-9001 certified production processes.

Miami Beach, Fl

Managed A/R balance sheet, brokered resolutions to contract disputes, and challenged credit card charge-backs by crafting persuasive briefs for creditors. Worked full-time while pursuing MBA.

Miami/Fort Lauderdale Area

Analyzed credit to advise Spanish-speaking clients seeking automobile loans.

Washington D.C. Metro Area

Prepared recap briefs for staff after congressional hearings on technology, terrorism, and other issues.

Bachelor Of Arts (Ba), Political Science And Government; Spanish Minor

Mba, International Business/Management

High School