A Senior Clinical Trial Manager job in Irvine,CA needs to be filled immediately by Adecco Medical & Science. This is a 1 year contract opportunity. This person will be accountable for leading the operational study team, which is responsible for the execution and delivery of quality studies including in-process quality control activities. Adecco Medical & Science is a division of the world leader in medical and scientific professional recruiting.
Senior Clinical Trial Manager job responsibilities:
Manage aspects of clinical trial including but not limited to: Pre-Study Activities, Start-Up Activities, Drug Management, Pharmacovigilance and Reporting and Site Monitoring.
Serve as the primary representative of Clinical Operations to Clinical Affairs supporting the execution and delivery of assigned study
Ensure accurate and timely entry of study information (e.g. design, results) into ClinicalTrials.Gov in collaboration with RAs and Clinical Affairs
Monitor study operational plan, and managing operational study budget, timelines, and risk mitigation processes with input from key stakeholders
Accountable for the management and maintenance of the study TMF
Lead and managing the process for the selection, contracting and oversight of CROs and clinical trial related vendors in collaboration with the study team, CRO Management, Clinical Affairs and key stakeholders
Provide operational input into the development and management of the IQMP and Risk-Based Monitoring Plan for an assigned study
B.S. degree required; Advanced degree (e.g. Master, PharmD, PhD) preferred
Minimum of 5 years of pharmaceuticals/biotech experience
Minimum of 5 years drug development experience in the pharmaceutical industry/CRO or commensurate clinical/medical research experience with emphasis on Phase II-IV clinical trials
Minimum of 1 year of dermatology experience strongly preferred
Proven leadership abilities and demonstrated experience directly working in multidisciplinary study teams Demonstrated ability to execute within a matrix management model, ideally in pharmaceuticals/biotech
Timeline, budget and resource management experience required
Demonstrated experience in change management initiatives preferred
Program and project management experience preferred
International experience a plus
If you are interested in this Senior Clinical Trial Manager job in Irvine, CA then please click APPLY NOW. For other opportunities available at Adecco Medical and Science go to www.adeccousa.com or email your resume to Melody.Lam@adeccona.com
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