Senior Study Manager Resume

SUMMARY

Highly organized clinical project manager with background in all phases of clinical research (I, II, III, and IV) with leading global scientific discovery and clinical practices in the pharmaceutical industry.
Over 16 years of experience in Oncology, Neuro - oncology, Cardiology, and many other therapeutic indications in both hospital and pharmaceutical settings.

AREAS OF EXPERTISE

PROFESSIONAL EXPERIENCE

Confidential

Senior Study Manager

Responsibilities:

Global Site Manager responsible for the operational and financial oversight of clinical trial sites in North America, South America, and the APAC region
Clinical supply liaison and management of Study drug supply to the above mentioned regions
Oversight of IVRS vendor; handled change orders, and additions to the system; held bi-weekly meetings to ensure proper management of issues and overall satisfaction of the study team
Worked with CRO for feasibility and review of 200+ new sites mid-way through study
Responsible for drafting and review of clinical trial documents
Attended and presented at Investigator Meetings and site oversight visits

Confidential

Senior Project Manager

Responsibilities:

Responsible for the operational and financial management of clinical trial planning and execution for three projects
Close collaboration with other members within Clinical Trial Management and with the multiple functional units of Confidential as well as headquarters
Develop and implement risk management strategies and contingency plans for clinical deliverables
Travel to sites and implementation of motivational/recruitment plans
Participate in team, department, and cross functional meetings
Oversee and mentoring of 3 direct reports
Develop budgets and ensure projects move forward within said restrictions
Oversee performance of Lead CRAs
Led sub-team working on Pediatric Plan for motivational visits and accurate forecasting of enrollment

Confidential

Sr. Project Manager

Responsibilities: