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Clinical Project Manager Resume
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| Desired Industry: Biotech |
SpiderID: 20653 |
| Desired Job Location: Toronto, Ontario |
Date Posted: 4/14/2008 |
| Type of Position: Full-Time Permanent |
Availability Date: 2 weeks from acceptance |
| Desired Wage: $80,000 |
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U.S. Work Authorization: No |
| Job Level: Experienced with over 2 years experience |
Willing to Travel: Yes, 50-75% |
| Highest Degree Attained: Masters |
Willing to Relocate: Yes |
Experience:
HIGHLIGHTS OF QUALIFICATIONS
Project / Study Management skills: demonstrated while working as an International Study Manager (ISM); simultaneously managing three high profile start-up studies, meeting all study milestones and staying within the established 3% annual budget variance of multimillion dollar study budgets. Received Project Management training tailored to the Regional Study Manager role & completed the required hours to obtain PMP certification.
Communication skills: excellent written and presentation skills demonstrated in final senior thesis (including defence) and as a presenter at various Investigator meetings while working as an ISM
Computer skills: Word, Excel, PowerPoint, Project, Lotus Notes, Bioinformatics
PHARMACEUTICAL / RESEARCH EXPERIENCE
April 2007 - Present
International Study Manager, GlaxoSmithKline PLC (contracted through VinCro Clinical Management Services)
- Co-lead and manage the implementation of global studies representing the International region within and across therapeutic areas
- Accountable to ensure all relevant studies follow GSK SOPs & GCP / ICH guidelines
- Lead the matrix team with key study partners (e.g. Regulatory, Compliance, Clinical Supplies, Country Medical Departments)
- Monitor and manage CRO and vendor performance
- Track timelines, identify risks and plan contingencies to ensure the study meets overall and regional timelines and recruitment milestones
- Manage study start-up, conduct, & close-out
- Ensure all participating International countries' unique timelines and regulatory requirements are met in line with overall study milestones
- Develop content, plan and drive execution and present at regional investigator meetings in South America, Africa and Asia
- Coordinate Clinical Operations input into informed consent form
- Contribute to status reports for program reviews and senior management
- Participate in key organizational process improvement initiatives (serves on GCO / MDC committees)
- Forecast, manage, phase and track study budgets up to $10 million within 3% target variance
- Assessed training needs of International CRAs and Study Managers and co-developed a 5 day, 200+ delegate training session in Santiago, Chile with input from senior management
January 2006 – April 2007
International Clinical Study Associate, GlaxoSmithKline PLC
- With limited oversight, managed the implementation of regional / global maintenance phase studies in the International region within and across therapeutic areas including oncology, gastrointestinal, infectious diseases and cardiovascular
- Support and assist International Study managers with all aspects of Study Management Key Responsibilities
- Was Accountable to ensure all relevant studies follow GSK SOPs & GCP / ICH guidelines
- Provide operational support for delivery of assigned studies or programs on time and within 3% budget variance; track timelines and identify contingencies and risk planning to meet overall timeline goals
- Maintained relationships and monitor performance of CRAs, CROs & other external vendors
- Responsible for accuracy of database systems
- Adhere to the Clinical model, collaborating with internal key matrix partners and external customers
- Serve as point of contact for questions related to functional area for internal and external customers
- Responsible for numerous activities outside study management including, but not limited to tracking performance metrics & benchmarking data for the international region and organizing and facilitating training sessions for new hires
- Job shadowed CRAs in several countries including Canada to in order to become familiar with their role
September 2004 – May 2005
Research Assistant, Dr. Campos, McMaster University
- Independently carried out laboratory experiments related to the generation and verification of mutant Drosophila lines (designed and carried out genetic crosses, DNA isolation, PCR, sequence analysis, Southern analysis, protein isolation)
- Published in the Journal of Molecular and Cellular Biology
- Prepared weekly progress reports for supervisor and monthly progress reports for the research team
Summers 2003 & 2004
NSERC Research Student, Dr. Campos, McMaster University
- Awarded two consecutive NSERC summer research positions based on academic merit and research proposal
- Research in both terms were related to senior thesis (using Southern blots to analyze mutant lines of Drosophila created through imprecise P-element excisions)
- Presented findings at the 2004 Ontario Undergraduate Biology Day Conference, North Bay, Ontario
Education:
2005 – 2007
University of Toronto, Toronto, Ontario
Master of Biotechnology, class of 2007
Awarded AstraZeneca University of Toronto Ontario Graduate Scholarship - 2005
2000 – 2004
McMaster University, Hamilton, Ontario
Honours Bachelor of Science: Genetics Specialization
Graduated Summa Cum Laude
Dean’s Honour List (2001 – 2004)
Affiliations:
Association of Clinical Research Professionals (ACRP)
University of Toronto Alumni Association, McMaster University Alumni
SHAD Valley Alumni
Candidate Contact Information:
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