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Vadim Paluy
Sunnyvale, CA
currently: Open for projects
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Work history
Ilypsa
December 2006 to the present
Clinical Trials Manager
tags:
clinical research
• gcp
• leadership & management
• management of clinical trials
How would you describe your time at Ilypsa?
*Successful planning and optimal placement of clinical trials
*Execution and management of clinical projects
*Oversight of project specific performance of internal and external contracts, including CROs and other vendors
*Review of study related manuals, materials and reports(Protocols, CRFs, Data listing review, etc)
*Accountable for successful operation of clinical trials through management and monitoring of progress, problem resolution and personnel issues
*Direction of team assigned in-house CRAs, Clinical Trial Specialists and Field CRAs as required
*Development of needed SOPs and working practices... 
Clinical Research Consultant
tags:
leadership & management
• gcp
• clinical research
• management of clinical trials
How would you describe your time at genentech?
?? Participate in the conduct of multi-center clinical research studies (Phase III: Ophthalmology)
?? Provide input for definitions of new or revised process development, contribute to creation and review of clinical study documents and monitoring tools
?? Determine resource requirements and evaluates the need to outsource; manage vendors to achieve team goals and specifications.
?? Identify potential investigators in collaboration with Project Management and Marketing to ensure the acceptability of qualified investigative sites
?? Evaluate, initiate and monitor sites in compliance with protocol, FDA guidelines, SOPs, and Study Monitoring Plan
?? Lead CRF Review and critique for accuracy and completeness, and all statistical listings for accuracy
?? Contribute to the project team by mentoring new members, assisting in preparations of project publications and/or tools, and sharing ideas/suggestions with team...
Clinical Research Consultant/Auditor
tags:
management of clinical trials
• auditor
• monitor
• clinical research manager
• gcp
• md
How would you describe your time at Placet Research?
Summary:
My formal training is as a board-certified psychiatrist and internist. However, I have had considerable research interests in multiple areas including oncology, immunology, infectious diseases, autoimmune disorders, AIDS, psychiatry, hematology, neurology, and pulmonary diseases among others. Having been associated with the pharmaceutical and biotechnology industry for 20 years as a Clinical Research Consultant, I have very extensive experience working with different types of organizations such as sponsor companies (i.e. Merck, Genentech, J&J, BMS, Daiichi, etc) and CROs (i.e., ICON, Advanced Biologics, PPD, CSMG, i3Statprobe, Covance, Kendle, Quintiles, MDS, etc).
THERAPEUTIC EXPERIENCE: Oncology, Neurology, Cardiology, Infectious Diseases, Autoimmune Disease, Internal Medicine, Ophthalmology, Pain management, Transplantation, Nephrology, Urology, Dermatology, Gastroenterology, Intensive Care, Travel Medicine, AIDS, Psychiatry, Pediatrics
Specialties:
Management of clinical trials (pharm/biotech/medical device industries); site/CRO/vendor AUDIT in US, Western and Eastern Europe; Maintenance and development of study protocols and plans, CRF, SOP, data validation plans, etc.; knowledge of GCP/ICH and FDA regulations, clinical and med research methodology and terminology (MedDRA, WHODRL); Set-up of investigating meetings, presentations; Liaison to sponsoring pharm companies and study participants; PROFESSIONAL TRAINING & COACHING...
Education
Internal Medicine
tags:
leadership & management
• medical doctor
How would you describe your time at Moscow Medical School named...?
Reports on annual student scientific conferences on clinical subjects, 1990-1996:
- News in treatment of chronic illness (distribution drugs by aerosols and bronchoscopic methods)
- Modern theories of chronic illness (connection between quality of life and oncology illness for patients with survival more than 3 years)
- Dietary regime for patients with Diabetes Mellitus
- Particularities of ulcers development (Helicobacter pylori as suspected cause of peptic ulcer; side effects of anti-inflammatory drugs)
- Psychiatric components in treatment of patients with chronic diseases (patient noncompliance, personality changes associated with different diseases)......
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Vadim has
