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Clinical Study Manager
Date: Jul 29, 2010
Location: Edison, NJ, US
Auto req ID 3318BR
Job Title Clinical Study Manager
Functional Area Research & Development
City Edison
State New Jersey
Job Description Job Summary:
The incumbent will be responsible for the overall management and implementation of global clinical research studies for the investigation of new drugs. Drug product candidates under investigation may belong to any therapeutic area. The incumbent will oversee performance and interactions with CROs and other external vendors. This individual will report directly to the Director/Assoc. Director Clinical Operations, and for project related activities, to the assigned Therapeutic Area Clinical Study Leader to ensure that clinical studies are conducted in a cost-effective manner according to the timelines, budget and objectives set forth by the Product Development Plan, and per Daiichi Sankyo procedures, FDA regulations/EU Directive and ICH GCP Guidelines
Responsibilities:
Develop study implementation plan. Participate in site selection and site qualification. Manage CRO performance and interface with CRO management for resolution of issues with implementation of clinical studies or resources. Ensure timely and cost-effective implementation of clinical trials. Manage GCP compliance issues and assure appropriate communication, issue resolution and adherence to SOPs and guidelines. Archive study material. Support preparation of Clinical Development Plans (CDPs), protocol profiles and clinical sections of NDAs. Manage completion of CRFs and other relevant study-related documents. Prepare drafts of entire Clinical Trial Protocols, Clinical Trial Reports and sections of Briefing Documents and INDs under the supervision of Clinical Study Director. Ascertain proper inclusion of appendices for study reports. Coordinate document review using appropriate tools. Assess signals in clinical database and propose monitoring strategies and preemptive solutions to CRO, Medical Monitor or Clinical Study Leader. Review and approve site contracts, informed consent forms, study budgets, work orders and invoices prior to final approval. Manage study drug coordination with CSO. Handle logistics for investigator meetings. Make presentations at management reviews, investigator and consultant meetings, as needed.
Education/Experience
Bachelor's Degree in Life Sciences or higher. A minimum of 3 years of experience in clinical research (at least 2 of these in Clinical Development) in pharmaceutical or device company, Academic Research Organization or CRO with BS. Minimum of 2 years of clinical research experience with MS, MPH, PhD or higher. Complete understanding of the concepts and applications of clinical research, medical terminology and other disciplines involved in drug development. Proficient skills in computer applications such as Word, Excel, and PowerPoint. Strong oral and written communication skills. Complete knowledge of GCP, FDA CFRs and ICH Guidelines. Ability to interpret data and to present results in a concise and clear manner. Management and leadership skills to contractors to the successful completion of the project. Working knowledge of the components and key content Requirements of IND & NDAs.
Job Title Clinical Study Manager
Functional Area Research & Development
City Edison
State New Jersey
Job Description Job Summary:
The incumbent will be responsible for the overall management and implementation of global clinical research studies for the investigation of new drugs. Drug product candidates under investigation may belong to any therapeutic area. The incumbent will oversee performance and interactions with CROs and other external vendors. This individual will report directly to the Director/Assoc. Director Clinical Operations, and for project related activities, to the assigned Therapeutic Area Clinical Study Leader to ensure that clinical studies are conducted in a cost-effective manner according to the timelines, budget and objectives set forth by the Product Development Plan, and per Daiichi Sankyo procedures, FDA regulations/EU Directive and ICH GCP Guidelines
Responsibilities:
Develop study implementation plan. Participate in site selection and site qualification. Manage CRO performance and interface with CRO management for resolution of issues with implementation of clinical studies or resources. Ensure timely and cost-effective implementation of clinical trials. Manage GCP compliance issues and assure appropriate communication, issue resolution and adherence to SOPs and guidelines. Archive study material. Support preparation of Clinical Development Plans (CDPs), protocol profiles and clinical sections of NDAs. Manage completion of CRFs and other relevant study-related documents. Prepare drafts of entire Clinical Trial Protocols, Clinical Trial Reports and sections of Briefing Documents and INDs under the supervision of Clinical Study Director. Ascertain proper inclusion of appendices for study reports. Coordinate document review using appropriate tools. Assess signals in clinical database and propose monitoring strategies and preemptive solutions to CRO, Medical Monitor or Clinical Study Leader. Review and approve site contracts, informed consent forms, study budgets, work orders and invoices prior to final approval. Manage study drug coordination with CSO. Handle logistics for investigator meetings. Make presentations at management reviews, investigator and consultant meetings, as needed.
Education/Experience
Bachelor's Degree in Life Sciences or higher. A minimum of 3 years of experience in clinical research (at least 2 of these in Clinical Development) in pharmaceutical or device company, Academic Research Organization or CRO with BS. Minimum of 2 years of clinical research experience with MS, MPH, PhD or higher. Complete understanding of the concepts and applications of clinical research, medical terminology and other disciplines involved in drug development. Proficient skills in computer applications such as Word, Excel, and PowerPoint. Strong oral and written communication skills. Complete knowledge of GCP, FDA CFRs and ICH Guidelines. Ability to interpret data and to present results in a concise and clear manner. Management and leadership skills to contractors to the successful completion of the project. Working knowledge of the components and key content Requirements of IND & NDAs.
Nearest Major Market: New Jersey
Job Segments: Clinic, Clinical Research, Database, Healthcare, Management, Manager, Medical Research, Product Development, R&D, Research, Technology
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