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Clinical Trial Manager
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Organization: Clinical and Systems Resource Group
View Company Profile of Clinical and Systems Resource Group :: View more jobs from Clinical and Systems Resource Group
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Job Description:
The Clinical Trial Manager position has three primary responsibilities: Execution of the clinical trial site monitoring functions of a clinical trial (e.g. those functions having to do with the clinical trial site), management of staff within the clinical trial management group, and development of standards and practices within the clinical trial management group.
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Skills Required:
Project Responsibilities
?Coordinate and manage vendor processes for the clinical trial site monitoring function of clinical trials including central laboratories and Clincial Research Organizations (CRO).
?May act as Protocol Lead on one or more clinical trials.
?Primary contact for CROs Clinical Trial Site Monitoring Team to ensure CRO’s performance to the terms of contract, CFR, ICH/GCP compliance, and overall quality of work.
?Coordinate day-to-day activities for the clinical trial site monitoring function of clinical trials including flow of documents and information to and from clinical trial sites and/or external vendors
?Facilitate the flow of information between contract CRAs, CROs and in-house team members, as well as, other relevant departments.
?Develop quality control program for each clinical trial and oversees implementation (i.e. clinical trial site co-monitoring, periodic review of adherence to clinical monitoring plan, etc.).
?Responsible for the quality and deliverables of the CRAs.
?Will assist with the design and review of clinical trial protocols in collaboration with medical monitor, biostatistician, regulatory affairs, senior management and other relevant groups.
?Participate in the creation and tracking of detailed clinical trial site monitoring plans for clinical trials.
?Participate in the evaluation, training and refining of departmental SOPs and guidelines, and the development of standard reports, templates and forms
?Problem-solve clinical team personnel issues.
?Participate in the identification, evaluation and selection of clinical investigators and clinical trial sites.
?Oversee drug accountability system, and collaborate with Investigational Drug Supply Chain.
?Maintain detailed clinical trial site and clinical trial subject information for assigned clinical trial sites via chosen clinical trial management system (CTMS)
?May assist in the preparation and follow-up of in-house and on-site sponsored quality audits, as well as, regulatory authority inspections.
Management
?Train and mentor clinical staff in trial management systems and tools, as well as, CFR, GCP/ICH requirements
?Manage internal (dotted line or functional) and external Clinical Resarch Associates (CRAs), and other external clinical trial service vendors as necessary.
?Serve as mentor to help assigned staff develop their career paths.
?Provide timely feedback to assigned staff on personal and project-specific performance, and provide guidance on performance improvements as necessary.
?Empower and coach assigned staff to accept responsibilty for their work, manage themselves and excel at their assigned projects.
?Perform performance evaluations twice per year to provide assigned staff with constructive feedback to enhance their performance.
?Establish and enforce department and corporate goals with staff.
?Review and revise staff project assignments as needed to balance workload.
?Ensure staff training is adequate and documentation of training is up to date.
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Qualifications:
?BA/BS or equivalent in a scientific discipline or any relevant and qualifying medical training with a minimum of 10 years of relevant clinical trial management experience.
?Experience in the Pharmaceutical/Biotech Industry is required.
?An advanced degree is a plus
?Experience managing CRO relationships
?Oncology and hematology clinical research experience preferred
?Experience managing clinical research staff is required.
?Ability and willingness to travel is required (domestic and internationally)
?Thorough knowledge of CFR and GCP/ICH requirements, as well as, European Clinical Trial Directive is required.
?Understand clinical drug development process.
?Proficient in development of clinical trial management tools and documents.
?Excellent communication and organization skills.
?Excellent clinical trial site monitoring skills.
?Ability to plan, organize and manage clinical trials .
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| Job Category: |
Biotechnology |
| Job Status: |
Full Time |
| Location:
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Seattle, United States |
| Start Date:
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ASAP |
| Salary:
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120,000 - 130,000 |
| Contact:
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Andrew Mammano |
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Email: |
Andrew@srgr.com |
| Reference:
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CTM Seattle |
| Date Posted:
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8/28/2008 7:07:56 PM |
| Duration:
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