Bree T. Jasminski
Milford
Summary
Highly organized Study Manager with background in coordinating and overseeing clinical trials. Possess strong knowledge of FDA regulations, protocol development, and data management. Known for effective team leadership, communication skills, and ability to manage multiple projects simultaneously. Noted for improving efficiencies in study processes and delivering high-quality results within project timelines.
Overview
27
27
years of professional experience
Work History
Study Manager
BAYER HEALTHCARE
Whippany
10.2007 - Current
- Manages and is responsible for all activities related to global and local clinical trials from the approved Study Concept to the Clinical Study Report.
- Develops the comprehensive overview and operational plans for the study.
- Manages operational study feasibility conducted by country organization to determine study feasibility and final country selection.
- Based on the feasibility summary, develops study timelines, milestones, outsourcing plan and proposed external study budget.
- Accountable for the development of the Core Study Documents and processes including: Data Collection tool (Remote Data Entry/Case Report Form), Study Monitoring Plan, Drug Forecasting and Clinical Study Report.
- Responsible for Study Protocol and ensuring adequate Investigator selection in each country to meet study enrollment and timelines.
- Responsible for developing the total external study budget and accountable for providing monthly and yearly estimates.
- Responsible for tracking study budget, initiating payments, providing monthly information to Controlling and GCL, identifying budget/estimate issues and proactively developing a plan for resolving study finance issues.
- Identifies, implements, leads and manages a cross-functional Study Team for the duration of the study, working with functional line management to identify team members and resolve issues.
- Core Global Study Team members include: Medical Expert, Study Statistician, Data Management Representative, Drug Safety Representative, Monitors (Clinical Research Associates), Global Regulatory Strategist, Global Medical Writer, Country Lead Monitors and External Supplier Management Representative.
- Disseminates relevant information to team members in effective and timely manner.
- Manages, tracks, and responsible for ensuring ongoing study activities, study execution and timelines are met.
- Tracks and compiles patient enrollment, data cleaning progress and overall study progress.
- Assesses and analyzes study information for variances and takes necessary actions within his/her responsibility to resolve variances.
- If necessary, initiates action with functional heads to resolve variances.
- Develops appropriate study related training for Study Team representatives (in particular for monitors) and site personnel according to GCP and BSP Global Development Standards to ensure quality and requirements necessary for global regulatory approvals and marketing needs are met.
- Manages Contract Research Organizations (CROs) and External Suppliers.
- Selects and develops contract specifications for external supplier in collaboration with Global External Supplier Manager.
- Responsible for defining outsourced tasks, developing outsourcing plan, training and managing external suppliers to ensure compliance with timelines and budget.
- Identify milestone achievements to initiate payments to external suppliers.
Medical Research Associate
BOEHRINGER INGELHEIM PHARMACEUTICALS
Ridgebury
06.2001 - 09.2003
- Participate in the operational activities involved in planning, conduct and completion of clinical trials.
- Recently received awards for outstanding performance on oncology and respiratory projects.
- Duties include protocol and CRF development, reviewing regulatory documents, preparing monitoring guidelines, participating in Clinical Project Team meetings, writing clinical trial reports, prepare and assist Drug Regulatory Affairs with reports necessary for requirements to the FDA including IND Annual Reports and New Drug Application, as well as corresponding with investigative sites and CRAs while adhering to governmental regulations and corporate SOPs.
- Maintain an active liaison with members of other groups involved in global drug development, particularly Data Management, Drug Regulatory Affairs, Research and Development, Drug Safety, and CRAs.
Clinical Research Associate
INTERNATIONAL PHARMACEUTICAL RESEARCH
Norwalk
12.1999 - 07.2000
- Performed field and in-house monitoring of clinical trial sites to ensure accuracy and completeness of all study record forms as well as protocol adherence.
- Duties included generating queries, tracking data clarification forms, and reconciling database listings.
- Responsibilities required comprehensive knowledge of medical terminology and FDA and ICH guidelines, in addition to a strong oncology background.
Senior Project Manager
DIAGNOSTIC ONCOLOGY CRO, INC.
Seymour
03.1999 - 11.1999
- Developed Clinical Trial Design including identifying Clinical Sites and developing Standard Operating Procedures.
- Managed Clinical Sites and CRAs as well as conducted Investigator Meetings and CRA Training to ensure protocol and regulatory adherence by all personnel involved in study.
- Performed field monitoring of multiple study sites to ensure compliance with FDA regulations.
Assistant Project Manager
DIAGNOSTIC ONCOLOGY CRO, INC.
Seymour
08.1998 - 02.1999
Clinical Research Associate
DIAGNOSTIC ONCOLOGY CRO, INC.
Seymour
05.1998 - 07.1998
Education
Bachelor of Science - Environmental Public Health
Southern Connecticut State University
New Haven, ConnecticutMasters of Clinical Research Administration -
George Washington University
Skills
- Microsoft Office
- MS Word
- MS Excel
- MS Power Point
- MS Outlook
- PAL 02/Remote Access
- Word Perfect
- IMS Software Applications
- Doc Image/Documentum
Timeline
Study Manager
BAYER HEALTHCARE
10.2007 - Current
Medical Research Associate
BOEHRINGER INGELHEIM PHARMACEUTICALS
06.2001 - 09.2003
Clinical Research Associate
INTERNATIONAL PHARMACEUTICAL RESEARCH
12.1999 - 07.2000
Senior Project Manager
DIAGNOSTIC ONCOLOGY CRO, INC.
03.1999 - 11.1999
Assistant Project Manager
DIAGNOSTIC ONCOLOGY CRO, INC.
08.1998 - 02.1999
Clinical Research Associate
DIAGNOSTIC ONCOLOGY CRO, INC.
05.1998 - 07.1998
Bachelor of Science - Environmental Public Health
Southern Connecticut State University
Masters of Clinical Research Administration -
George Washington University