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Toxicology External Study Manager (TESM) Job
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| Employer Name: BiotechCrossing |
SpiderID: 2267890 |
| Location: Raleigh, North Carolina |
Date Posted: 6/9/2008 |
| Wage: |
Category: Biotech |
| Job Code: 5320461 |
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Job Description:
Requirements Manages issues as they arise during study and immediately reports study findings as per SOP-R&D-0026 (15-day rule) Finalizes study reports in association with SA project team member and key contributing scientists Collaborates with CRO Study Directors, Worldwide Regulatory Compliance, DMPK scientists, SAPR, Peer Review Pathologists (PRPs) and scientists of other relevant disciplines to resolve expected and unexpected scientific, technical or quality issues. Ensures compliance and commitment to Good Laboratory Practices and worldwide regulations, Safety Assessment SOPs, protocols, policies and procedures. Ensures critical report dates are met, and any delays are communicated and captured accurately in report tracking system. In partnership with IO&BE WW CRO Management: Optimises GSK/CRO working interface across CROs globally. Acts as reference point for the Directors of General Toxicology for the global management of CROs, and for the management of scheduling issues. For General Toxicology, participates on teams conducting due diligence reviews for the qualification and selection of potential CRO partners. Ensures consistency of study conduct and reporting among CROs and GSK SA sites. Ability to understand all scientific aspects of a compound and project for which specific studies are assigned Recognized competency in general toxicology with knowledge of animal husbandry, physiology and pharmacology in diverse experimental animals (including rodents, rabbits, dogs, and primates). Broad practical and conceptual ability in the design, conduct, data analysis and interpretation, and reporting of results from preclinical studies. Broad and integrated knowledge of all aspects of the specific discipline and associated processes including any appropriate regulatory guidelines. Demonstrated ability to apply expertise in leading and/or driving studies conducted at CROs with a track record of effective monitoring of a wide variety of general toxicology studies in multiple species at CROs. Knowledge and experience of Safety Policies, Good Laboratory Practices and relevant local and international regulations relating to the conduct of toxicology studies and the care and ethical treatment of experimental animals. Understanding of pharmaceutical industry drug development and CRO interactions. Understanding and appreciation of the role of a Study Director at a CRO Ability to conduct critical evaluations and generate creative options for scientific approaches making prudent decisions to achieve desired outcomes.
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Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:
Contact Information:
| Contact Name: - |
Company Type: Employer |
| Company: BiotechCrossing |
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| City: Pasadena |
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| State: California |
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| Zip: 91101 |
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Web Site: http://www.biotechcrossing.com
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