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JOB SUMMARY

Provides customer-focused leadership in managing clinical projects across various phases, functional areas and assigned clinical staff. Accountable for the successful execution of all assigned projects, where success includes on-time, on-budget, high-quality/compliant project results that lead to satisfied customers. May have line management responsibilities.

JOB RESPONSIBILITIES

Project Leadership and Delivery: ?Manages a project as a project manager overseeing interdisciplinary clinical research studies and ensures compliance with GCP, relevant SOP’s, and regulatory requirements. ?Acts as a primary liaison between the Company and the Customer to ensure timely study launch, conduct, and closeout according to the Customer’s and the Company’s contractual agreement. ?Lead project team to ensure quality, timelines and budget management. ?Accountable for the financial performance of each project. ?Coordinate activities and deliverables of all study conduct partners and proactively identify and manage issues. ?Ensure studies are conducted in compliance with GCP, relevant SOP’s and regulatory requirements. ?Accountable for all project deliverables for each project assigned. Documentation and Reporting: ?Responsible for quality and completeness of TMF for assigned projects. ?Accountable for maintenance of study information on a variety of databases and systems. ?Responsible for study management components of inspection readiness for all aspects of the study conduct. ?Oversight for development and implementation of project plans. ?Plan, coordinate and present at internal and external meetings. ?Prepare project management reports for clients and management. ?Developing contingency planning and risk mitigation strategies to ensure successful delivery of study goals. Management: ?May be required to line manage other project management team members and clinical monitoring staff.

QUALIFICATION REQUIREMENTS

?Bachelor’s Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or equivalent combination of education and experience. ?Clinical research organization (CRO) and relevant therapeutic experience preferred. Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements ?Strong organizational skills. ?Strong ability to manage time and work independently. ?Direct therapeutic area expertise. ?Ability to embrace new technologies. ?Excellent communication, presentation, interpersonal skills, both written and spoken. ?Ability to travel as necessary (approximately 25%).