Bound Brook, New Jersey
about 1 month ago
Clinical Trial Manager
Bound Brook, NJ
Job Id: 9098
Are you looking to make a career change to a professional and stable company? This exciting opportunity offers a competitive salary plus an excellent benefits package including medical, dental and vision insurance as well as PTO. Does this position match your future career goals? Then this opportunity could be the right fit for you.
- Manages the day to day operational oversight and execution of study.
- Develops and maintain of quality project documentation including resources plan, risks plan, and communication plans, data management plans, Safety Plans, Pharmacy Manual, through the life of the project.
- Organizes investigator meetings and contributes to presentation of materials and the development of enrolment initiatives.
- Obtains required translations and collecting essential documents from site.
- Ensures sites are trained in collaboration with the CRO/site monitor.
- Anticipates and resolves challenges involving delivery of goals and objectives.
- Liaises with cross-functional team to influence solutions including final month 36 patient visits.
- Develops and implements study related operational processes throughout the study through forecasting, budget, potential modifications of the ICF, safety follow-ups, HA submissions study medication management, development of patient facing material, advertising material, and newsletters
- Manages external vendors to make sure study is successful; managing expectations of quality, timelines, and budget.
- Ensures that invoices from vendors are accurate and that work has been completed.
- Reviews/monitors reports, management of study enrollment including contingency planning, periodic review of protocol deviations, data review and trial master file management.
- Reviews of CSR shells, review of CSR/ appendices, finalization of the study protocol deviations, ensuring all documents are filed in the TMF appropriately
- Bachelor’s degree preferred
- Minimum of 5 years working in Clinical research
- Knowledge drug development and FDA regulatory guidelines
- Knowledge of clinical trial concepts and practices
- Familiar with clinical development and clinical operations
- Budget/finance -demonstrates full understanding of clinical budgets and understanding of project financials
- Excellent Communication Skills
- Assist with Drug Supply Management and Reconciliation
- Proficient in Excel, MS Word, and PowerPoint
- Medical Insurance
- Dental Insurance
- Vision Insurance
Ask for: Ashley
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