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Job Title: Associate Clinical Trial Manager/Clinical Trial Manager/Sr. Clinical Trial Manager
Description:
Responsible for the successful execution of clinical trials from the protocol concept through the clinical study report; ensures completion of study deliverables; develops Therapeutic Areas knowledge and expertise through internal training and external conference attendance. Typically works on studies with moderate to high complexity (in terms of design, location, phase, etc.). Follows established SOPs, GCP and other applicable regulatory requirements in the execution of all activities. Proactively identifies and resolves clinical project issues and participates in process improvement initiatives as required.
Manages all clinical aspects of study, which include the following:
Assessing operational feasibility and recommending study execution plan; developing and managing comprehensive study timelines and metrics; participating in selection and management of external vendors and developing vendor specifications; providing study-specific training and leadership to clinical research staff, CRO, CRAs, sites and other contract personnel; preparing and presenting project debriefings as required; planning, executing, and leading study-specific meetings (e.g., Study Management Meetings, investigator meetings, Advisory Committee); participating in site monitoring visits as appropriate.
Uses operational and therapeutic expertise to optimize trial design and execution: Works with the study team to ensure study objectives are met by designing clinical trial protocols consistent with the clinical development plan and developing an ongoing data review plan to ensure appropriate patient recruitment and detection of data trends. Prepares study-related documentation. Provides input for design of the ICF, CRFs, monitoring conventions, edit checks, etc.
Qualifications:
Knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management. Strong clinical study management skills. Excellent communication and organizational skills, along with problem solving, conflict resolution, leadership and team building skills.
Bachelor's degree or equivalent combination of education/experience in science or health-related field required
Compensation:
Commensurate with experience
Date Posted: 11/09/2007
Email Résumé to info@cougarbiotechnology.com
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Cougar Biotechnology, Inc.
10990 Wilshire Blvd, Suite 1200
Los Angeles, CA 90024
(310) 943-8040 Main
(310) 943-8059 Fax |
