Clinical Project Manager strong regional/global experience-Home Based Mexico Updated: Yesterday Location: MEX-Remote Job ID: Description Clinical Project Manager strong regional/global experience-Home Based Mexico 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. 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. Develops strong relationships with current clients to generate new and/or add-on business for the future. May participate in bid defense meetings where presented as potential project manager. May be required to line manage other project management team members and clinical monitoring staff. Qualifications and 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%). Summary Roles within Clinical Project Management job family are responsible for planning, directing, creating and communicating clinical study time-lines. Gathers input from cross-functional teams and creates plans that help the team produce deliverables on schedule. Ensures consistency of clinical study and processes across clinical trials, overseeing and resolving operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations such as site and vendor selection, preparing clinical trial budgets. Ensures studies are conducted within clinical trial protocols, monitoring progress and following up with team members and line managers when issues develop. Implements and prepares the clinical development strategy as outlined by the clinical teams. May develop trial recruitment strategies.Impact and ContributionIncludes executives as well as managers, supervisors and team leads providing strategic vision and/or tactical direction across a discipline and/or broader organization. The majority of time is spent overseeing their area of responsibility, planning, prioritizing, and/or directing the responsibilities of employees. Goal are achieved through management of process, policy, and performance of direct and/or indirect reports. Supervises experienced support employees and/or entry individual contributors. Delivers operational results that have moderate impact on the immediate achievement of results for the team. Broad job knowledge in an operational, administrative and/or specialized field, adapts new procedures, techniques, tools, etc. Understands basic management approaches such as work scheduling, prioritizing, coaching and process execution. Equal Opportunity Employer Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against. 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Clinical Project Manager Strong Regional/Global Experience-Home Based Mexico
SYNEOS HEALTH, INC.
americas, americas
Publicado hace 21 días
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