Senior Clinical Trial Manager

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• Seeking a highly motivated Sr. Clinical Trial Manager (SCTM) to be part of our Clinical Operations team. This is a unique opportunity to join a growing company committed to converting biologics and peptides into life-changing small molecule medicines for everyone. The SCTM will be responsible for the day-to-day oversight of global clinical trials and will manage internal stakeholders, CROs, multiple service providers, clinical monitors, and clinical trial sites. The SCTM will focus on the management and support of multinational, multicenter, late stage studies and may assume responsibility for additional studies/indications as applicable. The SCTM works closely with and supports the Clinical Development Operations team, receives assignments in the form of objectives, and will ensure deliverables are completed on time and within budget.
• This position will also work closely with a cross-functional team based in the US and Shanghai to ensure that clinical trials are conducted in a timely fashion and compliant with SOPs, ICH/GCP, Country specific regulatory guidelines, company goals, and budgets. The SCTM will be responsible for managing various project goals and supporting delivery of a quality clinical trial to meet current business needs and trends.

Responsibilities:

• Leads and coordinates global cross-functional study teams through all study stages (start-up, conduct, close-out).
• In collaboration with internal stakeholders, responsible for helping to drive the RFP and RFI process, analyze service providers, budgets and proposals, conduct bid defense meetings, award services, negotiate and execute complex agreements (i.e., CRO, study related collaboration agreements).
• Provides oversight and direction to the CRO and service providers to accurately coordinate clinical study activities.
• ssists with Inspection Readiness activities which may require the development, modification and/or implementation of policies as needed to ensure high quality and integrity in all study activities.
• Coordinate clinical study timelines with Project management and escalate issues that may impact timelines/ deliverables.
• Leads and/or participates in the development and review of study documents including, but not limited to, CRF design, project plans, Service Provider Oversight plans, TMF plan.
• Follows processes and procedures and recommend changes to SOP's and policies to ensure comprehensive and compliant processes in the clinical operations organization.
• Identifies potential study issues/risks, escalates as needed and recommends/implements
• Manages study sites and study related activities including but not limited to site feasibility, selection, start up, subject recruitment, enrollment, study management, monitoring report review, site management, trial master files, and data review/clean up.
• Coordinate with Lead and Finance to track the financial status against budget.
• Provide regular updates to Study Lead and other stakeholders; Proactively identify, manage, or escalate issues appropriately.
• Prepares or reviews clinical sections of regulatory submission documents, responses to EC and/or Health Authority questions.
• Monitors study progress for possible changes in study scope to ensure timely change order implementation and finalization; implementation of PI Training, site monitor training, etc.
• May have some responsibility for the oversight and management of the study budget including site and service provider budgets.
• Supervises ongoing communication of operational issues and provides accurate progress reports on assigned activities to Study Management Team and Clinical Development Team.
• Ensures oversight of data and information in study specific systems EDC, CTMS, eTMF is current and accurate.
• May lead a cooperative effort on a project team or contribute as a subject matter expert on key projects and initiatives to identify and implement process improvements and standards.
• Other supportive duties as assigned to achieve operational

Requirements:

• Bachelor's degree or equivalent (scientific or healthcare discipline preferred
• Minimum of 7+ years of related industry experience as a Clinical Research Associate or related function with increasing responsibility and scope
• Minimum of 3+ years study management experience in clinical and drug development
• Experience in selecting, managing, and overseeing sites, CROs, specialty labs and other service providers in global, multinational studies or programs.
• Experience in supporting SOP development and implementation is
• Experience working on global teams is desired, Asia-Pacific and EU highly

Core Competencies, Knowledge and Skill Requirements:

• PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
• In-depth understanding of FDA and EU regulations, ICH Guidelines and GCP requirements governing the conduct of clinical trials.