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| Title of job: |
Clinical Trial Manager |
| Job Location: |
Bridgewater, New Jersey, 08807 |
| Job Type: |
Contract
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| Price Range: |
| Negotiable, Depending on experience |
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| Start Date: |
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| End Date: |
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| Categories: |
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| #1 |
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Health Care |
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Health Care |
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Administration |
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| Qualifications: |
Other desired skills:
Clinical Trial Manager |
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| Job/Project Details: |
Our client, located in Bridgewater, NJ is seeking a Clinical Trial Manager for an immediate 6 month contract position DUTIES : Co-lead the Study Management Team (SMT) with Medical Director to include representatives from Biostatistics, Data Management and Epidemiology; Clinical Supplies, Health Outcomes, Regulatory, Pharmacovigilance, Medical Outsourcing, Regional Clinical Operations and other relevant departments -Responsible for the consistent planning, implementation and successful completion of clinical research activities for clinical trials of medium complexity -Ensure that clinical trials are conducted in accordance with State and Federal regulations, Good Clinical Practice regulations and internal Standard Operating Procedures -Follow and implement the Study Protocol Development Process in conjunction with the Medical Director and key members of the SMT (e.g. Biostatistician, Clinical Supplies Liaison, Data Manager, Regulatory Liaison, Pharmacovigilance, Health Outcomes, if applicable) -Conduct study operational feasibility assessments and risk assessments -Work with the Clinical Supplies Liaison and Medical Director to forecast and maintain adequate Clinical Supplies Interface with Medical Outsourcing and Purchasing regarding contract services. Ensure SMT participation in the development of study specifications/scope of work/project timeline for Request for Proposal (RFP) development. Ensure SMT participation in bid defense, vendor selection and contract finalization meetings -Work with SMT to develop study budget, including per patient costs, service provider costs, etc. Adhere to the Project Pre-Approval (PPA) and Purchasing policies; Ensure Sarbanes Oxley (SOX) compliance; Ensure study budgets are within forecast. Manage study budget and work with Finance for accrual and forecasting cycles For outsourced studies, responsible for the management of Clinical Research Organizations (CROs), and other service providers, and serve as the primary liaison between the sanofi-aventis SMT and the external teams -Oversee planning of investigator meetings; participate in the presentation of operational information -Review and provide feedback to functional SMT members on Monitoring Plan/Data Management Plan/Statistical Analysis Plan -Ensure timely distribution of Dear Investigator Letters (DILs) -Ensure study timelines are met, oversee that study progress is reported and tracked, results and any significant findings are discussed with the SMT, and ensure that the study status within the clinical trial tracking databases (IMPACT; ClubNet) are maintained -Ensure payments are made to CROs and investigator sites for the duration of a study -Communicate with Investigative sites regarding study progress issues, communicate regularly with contacts within Joint Venture organizations, when appropriate, and communicate study progress/status on a regular basis to the Director, Medical Operations, to the Medical Director, to the Vice-President, Medical Operations and to the Vice-President and Sr. Director, Medical Affairs -Assure proper study documentation is maintained and archived in the TMF -Facilitate and actively participate in process improvement initiatives, taskforces and committees within Medical Operations and cross-functionally SKILLS: -At least five (5) years of clinical research in the function of clinical trial manager is required -Knowledge of drug development -All phases of the clinical research process including protocol and case report form design, clinical investigational site monitoring, data management, etc. -Experience working in the area of CNS, specifically insomnia, is preferred -Ability to work with a continued focus on quality, efficiency and ongoing improvement through decision making, planning and organizational skills, communication and quality orientation -Proven interpersonal, communication (written and verbal) and organizational skills -Proven ability as an effective leader is required (e.g. training, decision making, problem solving, negotiating etc.) -Commitment to teamwork -Ability to utilize various electronic systems and softwareï¿ intermediate computer skills required -Ability to travel (minimal) EDUCATION :Bachelor degree in a relevant scientific discipline Headquartered in Princeton, New Jersey, technologyBROKERS and clinicalBROKERS are full service staffing solutions companies dedicated to providing qualified technical and clinical professionals to our clients. Member Companies of The Brokers Group provides Consulting/Contract, Contract to Hire, Full Time Direct and Project Outsourcing Solutions. Our thorough candidate pre-screening process allows us to present the most qualified professionals for any staffing need. Our success is a result of strong client partnerships where we have a solid understanding of our clients corporate structure, culture, and how our candidates can contribute to their business. In addition, our solid relationships with our candidates allow us to find the best suited environment and opportunity for each individual. Our consultants select us for the personal touch and thorough understanding of what a professional needs. They prefer to work with a company that prides itself in working with only the best people in the highest ethical manner. They know we strive to find for them the best opportunity full of exciting challenges, experience and most importantly, an opportunity to advance their career.df-jb |
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