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Clinical Trial Manager (WA)
Eligibility : Bachelors in scientific discipline, RN or health care professional or equivalent. An advanced degree
Location : WA/Other
Designation : Clinical Trial Manager (WA)
Details ::
Makro Technologies
About Verna Scientific:
Verna is a multidisciplinary Life Sciences firm, Verna specialize in Consulting and Staffing services for Fortune 1000 as well as start-up companies in Biotech, Pharmaceutical and Healthcare industries with major focus on clinical research and data management. Verna is growing rapidly and we are always looking for individuals with outstanding capabilities in clinical arena. We offer careers in both technology and research disciplines. Verna's expertise has earned us an esteemed reputation within the industry and with our clients such as Schering-Plough, Astra Zeneca, Purdue, Abbott Labs, Merck, Wyeth, Allergan and Amgen.
Urgent requirement for one of the our top client located in 'WA'.
Responsible for the monitoring and conduct of a clinical trial, both directly and working with contracted organizations (eg CROs). They are the supervisor of all monitoring activities and directly accountable for the deliverables of a quality trial that is completed on time, in accordance to ICH/GCP and the needs of the company. In addition, this person will oversee and act as mentor for less senior members of the Clinical Trial Team and will manage direct reports.
Coordinate and manage vendor processes for the monitoring function of clinical projects including monitoring, data management, and central laboratories.
Act as Protocol Lead on one or more projects
Primary contact for CROs Clinical Monitoring Team to ensure their performance to the terms of contract,ICH/GCP adherence, and overall quality of work.
Coordinates day-to-day activities for the monitoring function of clinical studies including flow of documents and information to and from sites and/or external vendors
Facilitate the flow of information between contract CRAs, CROs and in-house team members and other involved members of the department and cti.
Develops quality control program for each clinical trial and oversees implementation (i.e. co-monitoring, periodic review of adherence to monitoring plan, etc.).
Requirements:
10+ years Clinical Monitoring experience or equivalent, including 5 yrs CRA/CRO management experience or equivalent. Experience in the Pharmaceutical Industry is required.
Bachelors in scientific discipline, RN or health care professional or equivalent. An advanced degree is a plus
Experience managing CRO relationships desired.
Oncology and Hematology Clinical Research experience preferred
Past experience working in both a CRO and sponsor a plus
Experience managing personnel is required.
Ability and willingness to travel is required (domestic and internationally)· Thorough knowledge of FDA and ICH requirements·
Contact:
The most effective way of communication is via email please forward us your updated WORD FORMAT resume (Address, Contact number and email is must) Please mention your best hourly rate, availability and visa status. Any questions, do feel free to email us
About Verna Scientific: Verna is a multidisciplinary Life Sciences firm, Verna specialize in Consulting and Staffing services for Fortune 1000 as well as start-up companies in Biotech, Pharmaceutical
Salary : Not specified
Company URL :
Last Date : 2007-12-26
Address: Srilaxmi
       
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