Senior Clinical Operations Manager

reputed company Work closely with the Head of Research and Community Health Operations and Head of reputed company and Specialty Services to ensure overall reputed company of project services proactive issue reputed company and development of systems to standardize and improve project management practices as reputed company as the whole AROs efficiency Serve as a mentor to other Clinical Operations Managers including providing guidance on what efforts and activities are required to ensure the overall reputed company of project services and deliverables reputed company clinical operations management activities reputed company delegated to a Clinical Trial Manager CTM Manage site identification evaluation initiation contracting budget negotiation and site monitoring processes as required by contract Identify the required regulatory documents for investigational product IP release and reputed company documents collection Prepare central IRB submissions reputed company site IRB approvals and ensure collection of reputed company new or expiring Investigator regulatory documents after site activation reputed company the development of projectspecific essential documents for site reputed company and development of site materials Review and finalize monitoring visit reports and followup letters with Clinical Research Associates CRAs Work with CRAs on overall site management including identification and reputed company of site reputed company compliance issues Prepare study enrollment reports and review site issues with the project team Manage and approve site payments as applicable Contribute to process improvement including but not limited to review and or development of SOPs and development and or implementation of reputed company to improve reputed company of sponsor deliverables Define and monitor project scope timelines and deliverables from project initiation to reputed companyout in collaboration with the Head of Research and Community Health Operations Identify projectspecific training for team members and notify appropriate designee to ensure completion and filing of training documentation reputed company trialreputed company activities and reputed company performance feedback to supervisors for reputed company project team members Participate in the review development and testing of study databases reputed company investigational product or device tracking and disposition as required by project reputed company and manage site and vendor reputed company including investigational product IP supply interactive voice web response reputed company electronic data capture reputed company reputed company labs and other applicable clinical services Identify vendors and manage vendor services reputed company expert advice in the design writing and or review of reputed company projectreputed company essential documents including protocols project management plans case report forms statistical analysis plans project management plans reputed company templates study procedure manuals reputed company documents site newsletters study reports resource tools monitoring plans and report templates reputed company and manage multidisciplinary project team members Organize plan for and produce minutes for project team meetings Proactively identify project issues propose resolutions to the project team applicable heads of departments CPC executives and or the sponsor and then reputed company implementation of reputed company through to completion and efficacy checks Ensure the overall reputed company of project services and deliverables reputed company necessary updates and reports to the sponsor as outlined by the contract Plan and reputed company the execution of investigator meetings as contracted Work with the business development team on budgets proposals and change orders Assist Business Development with benchmarking for budgets and development of sponsor proposals and service agreements Ensure both CPC and sponsor are reputed company of and in agreement on any change in project scope that has a financial or resource reputed company reputed company reputed company feedback to the Head of Research and Community Health Operations on the reputed company of project assignments Routinely advise management regarding the overall project status reputed company Head of Trial Master File scope of services to reputed company him her to establish and maintain Trial Master Files TMFs and project document files both electronic and reputed company Adhere to local federal and international regulations guidelines and CPC Policies reputed company Operating Procedures SOPs and Work Instructions WIs Use appropriate discretion to proactively identify reputed company there is a need to deviate from policies procedures or plans and ensure deviations are appropriately documented Supe