Senior Clinical Trial Manager

A Senior Clinical Trial Manager job in Irvine, CA is available through Adecco Medical and Science. The Sr. CTM is accountable for leading the operational study team, which is responsible for the execution and delivery of quality studies, including in-process quality control activities. Requires advanced knowledge of the functional disciplines necessary to guide the operational objectives to ensure execution and delivery of quality studies within defined timelines and budget.
Sr. CTM job responsibilities include:

As the operational study lead, serves as the primary representative of Clinical Operations to Clinical Affairs and other functions supporting the execution and delivery of an assigned study(s) (e.g. Clinical Planning, Regulatory Affairs, Global Drug Safety, Pharmaceutical R&D, R&D Quality Assurance)
Supports the Clinical Program Manager by providing study status updates, and informs and as needed escalates issues; Provides operational support as needed at various meeting interactions with, as example, advisors or Partners
Accountable for the execution and adherence to integrated study operational plan (start up, conduct, close-out, and vendor oversight) with input from key stakeholders inclusive of all operational accountabilities, including adherence to all relevant regulations including GCP, ICH and Regulatory requirements, as well as FRI’s SOPs and policies.
Accountable for accurate and timely entry of study information (e.g. design, results) into ClinicalTrials.Gov in collaboration with RAs and Clinical Affairs
Accountable for monitoring study operational plan, and managing operational study budget, timelines, and risk mitigation processes with input from key stakeholders
Accountable for direct supervision and mentoring of Clinical Trial Managers
Accountable for oversight of Clinical Trial Manager activities
In collaboration with key stakeholders, responsible for supporting the development and application of standardized operational study processes, methodologies, appropriate quality and performance metrics and tools to systematize continuous process improvement and impart best practices across clinical operations to maximize its effectiveness.
Accountable for the management and maintenance of the study TMF
Accountable for leading, 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

QUALIFICATIONS:

B.S. degree; 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
Extensive experience in the operational and scientific/medical aspects of clinical development.


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. If you have questions about the position or would like more information, please contact Sindie Rothstein at 858-410-1108 or by email at Sindie.rothstein@adeccona.com.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled




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Reference number US_EN_2_108175_330975