MARIA RAMIREZ
**********@*****.***
HTTPS://WWW.LINKEDIN.COM/IN/MARIA-R-832A3038/
PROFESIONNAL PROFILE
TRILINGUAL : French 5/5 Spanish 5/5, English 4/5
COMPUTER SKILLS: Proficient with Microsoft Office: Word, Excel and Power Point, MS Project, Visio, MS. Office, Outlook, SPSS, CRM, ERP system, Work front
KEY SKILLS:
Good interpersonal, coordination and communication skills
Team building, specifically experience with multi-disciplinary teams
Recognized for my dynamism, positivism and high level of energy
Strong strategic thinking and networking skills with good business acumen
Strong strategi
EXPERIENCE
05/2016-today Clinical Project manager/CRA Biox Clinical Research (Montréal, QC)
Responsible for the general oversight of clinical issues, personnel and for the provision of high quality clinical data
Assemble and lead the clinical trial team and conduct effective team meetings
Monitor patient safety on-site (review for missing SAEs, AEs,) and address protocol violations
Manages study sites to ensure studies are completed on time, within budget and in compliance with SOPs
Conduct the following monitoring visits according to GCP/ICH guidelines, Working Instructions, Protocol Specific Monitoring Plans, and departmental timelines
Maintains effective communication practices throughout the trial
Manages client relationships and client expectations
Ensure the design, implementation and timelines of study deliverables are consistent with client requirements and budget expectationsr
Negotiates investigator contracts and budgets, reconciliations, and payments to Investigators
12/2015-05/2016 Clinical Study Specialist/CRA JSS Medical Research (Montréal, QC)
Assist with all start-up activities prior to site activation
Assist with identification and tracking of new sites
Collect the required investigator and regulatory documents to perform clinical trials
Supervises the conduct of chronic diseases and diabetes clinical studies and verifies the integrity of investigator files
Review with investigators the obligations inherent at the end of the study and writes closure visit reports
Arrange on-site visits and logistics
EXPERIENCE
04/2015-12/2015 Clinical Study Coordinator JSS Medical Research (Montréal, QC)
Provide clinical support for ongoing trials and training of technical personnel in clinical sites
Monitor and report all adverse experiences and abnormal results to the Investigator and Sponsor
Provides support to Data Management for specified study activities and coordination with Clinical Operations
Utilize proven quality control tools to collect and measure performance data and participate in or lead process improvement initiatives
09/2013-04/2015 Quality Business Developer and Project Manager Iso-Process (Montréal, QC) part-time
10/2012-08/2013 Laboratory Equipment Representative Roche Diagnostics (Sherbrooke, QC)
MBA CONSULTANCY PROJECTS
11/2014 - 02/2015 Project manager BiogéniQ (Montréal, QC)
Objectives: Create and implement a marketing strategy concerning a new product for a growing healthcare organization.
Deliverables: project management plan, marketing strategic plan, marketing strategy implemented
11/2013-04/2014 Project Manager Bombardier Aerospace (Montréal, QC)
Objectives: Implementation of Six Sigma Infrastructure
Deliverables: Project Management Plan, Final consultancy report, six sigma infrastructures implemented
EDUCATION AND TRAINING
2017 Master in project management (MGP) (Montréal, Québec)
École des sciences de la gestion (ESG UQAM)
2015 Master in business administration sciences (MBA) (Montréal, Québec)
École des sciences de la gestion (ESG UQAM)
2013 Bachelor of Sciences Pharmacology (Sherbrooke, Québec)
University of Sherbrooke