Clinical Study Manager for Pharmaceutical Company in Overland Park, KS

Smith Hanley has an outstanding new opportunity for a Clinical Study Manager for our client in Overland Park, KS.  Position Description: Study Management Leading Study Teams and ensuring progress of studies within timeline and budget Managing Study Teams to integrate the work and input from all functional members of the team Reviewing study protocol and providing operational input Oversight of study budget development and tracking Preparing or participating in preparation of various plans/documents for study and execution plan, Monitoring and reporting on status of study deliverables Managing vendors and ensuring that all key milestones are met Providing status updates to Study Team and occasionally Clinical Development Team (as needed) Resolving issues that arise over the course of study Ensuring timely close-out of study Develop detailed study timelines  Clinical Operations Providing status updates to Study Team and occasionally Clinical Development Team (as needed) Performing protocol related site management activities Identifying prospective sites and reviewing feasibility from operational perspective  Minimum Requirements:  BA/BS or equivalent degree preferably in life sciences or medically related field Typically 6 years experience in life sciences or medically related field, including 3 to 5 years experience in Clinical Development (e.g. CRA or equivalent) Understanding of drug development process Experience in interactions with outside vendors, e.g., CROs and contract labs Experience with administration of site budgets and grants with supervision Experience with development of prospective site-selection criteria Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements preferred Excellent writing and presentation skills with the ability to appropriately use scientific and clinical issues terminology Experience in Clinical project planning including oversight of study deliverables, budgets, and timelines Experience working on clinical studies conducted internationally preferred Experience working effectively in a team/matrix environment Capable of dealing with time pressures and incomplete information or unexpected events Good organizational and planning skills, particularly good at time management Ability to anticipate and resolve problems Attention to detail Ability to create strong team spirit and make people go the extra mile Strong skills in written and oral communication Ability to understand technical, scientific and medical information Results focused Demonstrated flexibility in a dynamic environment Takes initiative Policy, process and procedural conformance Familiarity with current clinical trial software technology If you are interested in this position, we invite you to please email a MS-Word copy of your resume to Cheryl Dapkus at cdapkus@smithhanley.com , or if you have any further questions please call 1-800-684-9921 Ext. 256.We look forward to hearing from you! If you would like to be considered for this opportunity, please forward your resume to the email address provided below. If you meet the minimum requirements someone will be in touch with you to discuss the specific details. Education Level: Bachelor's Degree Job RefCode: 3025236 Email: Apply by Email