7+ years of clinical research experience with a focus on increasing responsibilities
3+ years of study management in drug development
Proven history in managing CROs and global clinical studies
Experience in SOP development and implementation
Experience working with global teams, particularly in Asia-Pacific and EU
Responsibilities
Leads global cross-functional study teams from start-up to close-out stages
Drives the RFP/RFI process and manages budgets and proposals
Provides oversight to CROs and service providers for clinical study coordination
Ensures inspection readiness and implements quality assurance policies
Coordinates study timelines and addresses potential issues impacting deliverables
Manages study sites through feasibility, selection, and monitoring activities
Prepares and reviews regulatory submission documents and stakeholder updates
Benefits
Opportunity to work in a growing company focused on innovative small molecule medicines
Collaborate with a cross-functional team in both the US and Shanghai
Engage in multinational and late-stage clinical trials
Dynamic work environment with an emphasis on timely and compliant trial execution
Potential for involvement in policy development and process improvements
Full Job Description
Position Summary:
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. Needs to be able to work PST Hours.
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.
Job 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
Experience:
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, Skill Requirements and Education:
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.
Bachelor's degree or equivalent (scientific or healthcare discipline preferred)
