AD/D Clinical Operations

该职位来源于猎聘 Key Responsibilities

• Line management of Clinical Operations staff, responsibilities includingprofessional development, performance appraisals, and employeecounseling for junior and management staff.
• Manage senior level professional staff. Provide expert operationsoversight and guidance. Sets priorities and schedule activities ofdepartmental resources, implement company objectives, and createalternative solutions to address business and operational challenges.
• Ensures quality and adherence to Standard Operating Procedures/WorkInstructions (SOP/WI) and compliance with federal and local guidelinesand ICH/GCP.
• Ensures individual and team tasks are completed according to countryspecific and government regulations. Ensures all staff follow requiredtraining and completes the required documentation.
• Manage resource availability for the assigned country(-ies) or region(s),ensuring projects are suitably resourced and staffing needs areidentified in a timely fashion, resolving potential resourcing conflicts tofacilitate mutually beneficial resolutions.
• Supports the development of the regional staff plan, identifying needs tohire new staff in a timely fashion and oversee the talent acquisition process in the assigned country. Proactively works to ensure. staffretention and turnover rates remain within expected levels.
• Manage and control the financial performance in the assigned country(-ies) or region(s), ensuring that departmental targets are met forutilization, gross profit, revenue realization and cost control (includingcontractor use and staff overheads).
• Maintains awareness of project resourcing issues, hours and overallworkloads. Ensures that project clinical operations goals are met withinappropriate timelines. Provides regular updates to the assignedBusiness Unit Leadership accordingly.
• Works closely with other departments to ensure quality performance onall studies as well as to correct process deficiencies as identified bystaff, clients, and auditors. Assist in the resolution of any project-relatedissues/findings associated with the performance of Clinical Operationsstaff. Participates in committees and work groups to support thedevelopment of corporate best practices and processes.
• Provide support to Business Development to facilitate new projectawards during the Bid Defense process, providing expert ClinicalOperations guidance where required. May participate in marketingactivities, client presentations and proposal development Preferred Experiences and Skills：
• Minimum of 10 years of progressive experience in clinical researchwhich includes at least 5 years in line management or projectmanagement experiences preferred.
• Extensive knowledge of GCP/ICH guidelines and other applicableregulatory requirement.
• Strong leadership, tactical and strategic thinking skills. Demonstrateunderstanding of the workflow process, roles and responsibilities ofmultiple functional areas. Knowledge of financial concepts as related toforecasting, budgeting, and proposal generation.
• Excellent communication, presentation, interpersonal, and changemanagement skills, both written and spoken, with an ability to inform,influence, convince, and persuade.
• Must demonstrate proficiency in Microsoft Office Suite (Word, Excel,and PowerPoint), email, and voicemail.
• Ability to travel as necessary (up to 20%)