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 Job #03134 Email this job to a friend
About our client
Our client is a global drug development services company. 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
Associate Director of Clinical Research Massachusetts
Salary
Highly competitive package, commensurate with experience
Responsibilities
1) Lead the company's India operations as International Project Manager
2) Submit reports on international operations to management
3) Recruit investigators as well as negotiate study budgets and contracts
4) Review and approve regulatory and other documents from Investigator sites
5) Plan, coordinate and remain present at investigators’ meetings
6) Review and develop protocols and CRFs
7) Manage interdisciplinary clinical research projects as a Project Manager, leading the Clinical Team to ensure on-time and on-budget performance
8) Review Serious Adverse Event (SAE) reports
9) Review and approve monthly client invoices
10) Prepare project management reports
11) Review and approve monitoring trip reports
12) Author clinical study reports
13) Review tables and listings generated from study data
14) Supervise, train and mentor Clinical staff on monitoring, SOPs and procedures
15) Mentor senior CRAs and managers on project management procedures and policies
16) Participate in proposal meetings with potential clients
Requirements
1) Bachelor's degree
2) 8 years of experience in clinical research/data management/regulatory affairs or 6 years, with relevant doctoral degree (Oncology preferred)
3) Minimum 4 years of experience in the monitoring and management of clinical research projects
4) Proven experience of handling an overseas office (India preferred)
5) Excellent communication (written and oral) skills
6) Willingness to travel – up to 40%

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