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Clinical Trial Manager BIND Biosciences
THIS JOB HAS EXPIRED
Position SummaryReporting to the Head of Clinical Operations, the successful candidate will be responsible for all aspects of clinical trial management including but not limited to study planning and execution, timelines and budget, vendor management, preparation of study related materials, and relationship management between clinical sites and vendors.
Essential Functions:
Responsible and accountable for one (or more) concurrent clinical studies
Regularly meet with the Head of Clinical Operations to discuss overall clinical trial(s) plans, update forecasting, and potential issues or recommendations
Manage activities associated with routine and advanced trial start-up, conduct and closeout activities
Prepare and present trial specific updates to management. Manage vendor to scope of work, quality, and budget.
Review and approve vendor invoices and manage accruals
Contribute to the writing and review of clinical documents such as protocols, informed consents, investigator brochures, monitoring plans, trial reports and annual reports
Manages trial budget & MS Project timeline
Participates in contracts and budgets negotiations with clinical sites and vendors
Participates in the coordination of Investigator meetings and all other study management meetings
Reviews and approves corrective action plans at individual site and across study, may participate in internal/external study related audits
Must be able to monitor as needed
Education, Skills, and Experience
BS Degree in science or a health related field is required, RN preferred
Minimum 3 years relevant industrial clinical development experience, with at least 3 years of managing multi-disciplinary project team
Willingness to travel domestically and internationally
Applies project management best practices Strong verbal and written communication skills
Excellent interpersonal and organizational skills
Ability to deal with competing priorities, strong reasoning, detail oriented and problem solving ability is essential
Ability to work on teams and with multiple projects, and works well under general direction with tight timelines
Working knowledge of medical terminology
Excellent knowledge of GCP, ICH and FDA regulations
Independently motivated
| Location: | 101 Binney Street Cambridge, MA 02142 United States |
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THIS JOB HAS EXPIRED
BIND Biosciences
Investors: ARCH Venture Partners, Flagship Ventures, Polaris Venture PartnersAll Jobs: at BIND Biosciences
| Web Site: | www.bindbio.com |
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| Headquarters: | 101 Binney Street Cambridge, MA 02142 United States |
| Industry: | Biotechnology |
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