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 Job #02752 Email this job to a friend
About our client
Our client is a global, publicly traded drug development services company headquartered in New Jersey. The company has strong financials, an experienced management team and a loyal customer base. They have developed an industry-wide reputation for a positive work environment and an aggressive training program that ensures employees are up to date on current trends and best practices. This is a strong opportunity for someone that wants to put their drive and initiative to work!
Position Location
Clinical Research Manager Framingham, Massachusetts; Blue Bell, Pennsylvania; Wilmington, Delaware; San Diego; California; Princeton, New Jersey; Deerfield, Illinois; Morrisville, Charlotte, North Carolina
Salary
Highly competitive package, commensurate with experience
Responsibilities
1) Manage interdisciplinary clinical research projects to ensure on-time and on-budget performance
2) Supervise, train and mentor the Clinical Research staff
3) Review and approve regulatory and administrative documents from investigator sites
4) Approve investigator study budgets and contracts
5) Review and develop protocols
6) Plan, coordinate and be present at investigators’ meetings
7) Review and approve CRFs
8) Participate in proposal meetings with potential clients
9) Review Serious Adverse Event (SAE) reports
10) Train CRAs on monitoring, internal procedures and query resolution
11) Review and approve monthly client invoices
12) Prepare project management reports for clients, project personnel and management
13) Review and approve monitoring trip reports
14) Author Clinical Study Reports (CSRs)
15) Review tables and listings generated from the study data
16) Mentor senior CRAs on project management procedures and policies
Requirements
1) Bachelor's degree or RN
2) Minimum 5 years of clinical research experience (oncology preferred)
3) At least 2 years of trial management experience in a pharmaceutical/biotech company or CRO
4) Excellent organizational skills
5) Ability to manage time and work independently
6) Excellent communication skills (written and verbal)
7) Willingness to work in the office when not traveling
8) Willingness to travel – up to 20%

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