职位描述

职位描述： JOB RESPONSIBILITIESIndicate the primary responsibilities critical to the job.Responsible for country site management and clinical/medical/scientific oversight for assigned studies:Site Management & Delivery:?Provide country/regional level input to country strategy, feasibility and protocol design in collaboration with relevant Medical Affairs colleague, and with input from external clinical experts as required. Applies clinical development strategy in the assessment of country and site selection at the asset level?Provide recommendations on potential sites and provide targeted follow up with key sites as required. Influence the study teams in the selection of INSPIRE sites?Oversee and support study start up activities at the country level, including review of key documents (eg local Informed Consent Document template), and providing support to address regulatory and/or ethics committee questions.?Oversee and support study start up activities at the site level, including management of emerging issues that may compromise time to site activation.?Provide enrollment support and ensure progress by responding to start-up and recruitment issues from investigators, partner with study team to define and support recruitment initiatives at site / country level?Lead effective site recruitment planning and implementation of plans at the country and site level, consistent with global plan and local specificities?Support database release as needed.Clinical/Medical/Scientific Oversight:?Be proactive in ensuring overall site quality, regulatory and GCP compliance.?Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators and site monitors.?Provide protocol training to, and address protocol related questions from, the investigator site staff, site monitor and other RCSLs when required. This may include attendance at investigator meeting and/or site initiation visits and should involve discussions on known/anticipated operational and clinical risks.?Create and manage (the study oversight plan) and mitigate for known/anticipated risks proactively.?Monitor site performance using appropriate tools and resources (e.g. metrics, site health, Risk Based Monitoring signals etc) and take appropriate targeted action.?Apply knowledge of data and analytics to target site, study and asset level actions for mitigation and control.?Conduct and report oversight activities, both remote and onsite visits according to Pfizer standards.?Proactively identify, manage and escalate site issues.?Help to address Significant Quality Events or other quality issues at patient and/or site level.?Ensure resolution of investigator site issues in order to maintain sound investigator relations.?Communicate with investigators and study coordinators on a regular basis to build and maintain productive relationships and support investigator engagement through medical and scientific discussion.?Provide support for site audits/inspections as needed.?Maintain a thorough knowledge of assigned protocols.?Demonstrate TA/Category expertise where appropriate.?Colleagues with MD equivalent qualification and required experience will take on medical monitoring responsibilities, including participation in 24/7 medical cover, being the local point of contact for medical issues and assisting with complex safety, eligibility and other patient or protocol issues.Study Team Interface:?Interface with the study team as needed and act as representative of the RCSL function.?Champion and ensure update of existing tools / processes related to clinical site selection and management.?As needed, facilitate the exchange of information to / from the study team on study progress and impact of local clinical development environment on study / site.?Provide regional and cross-regional insights on study-site performance and trends to / from the study team.Country/Regional Environment Management and Across Study Trends:?Provide regional and cross-regional insights on trends (eg study/asset level issues, cultural differences, evolving local regulatory environment etc).?Maintain a thorough knowledge of country/regional clinical trial regulations and the country/regional clinical development environment.?Provide insight on appropriate sites/strategic alignment of networks (eg INSPIRE network) that would be supportive of the evolving geographic footprint for the current portfolio.QUALIFICATIONS / SKILLSIndicate qualifications and skills that are necessary for performance of responsibilities including: education, relevant experience, licenses, certifications and other job-related technical and managerial skills.?A scientific or technical degree in the healthcare field or an MD / MD equivalent degree along with:1.Extensive knowledge of clinical trial methodologies2.Must be fluent in English. Multi language capabilities are an advantage in this role.3.In general, candidates for this job would hold the following levels of education/ experience:？BS/BSc/MS/MSc or equivalent with demonstrated clinical research experience？PhD/MD or equivalent with demonstrated clinical research experience.?Demonstrated knowledge of clinical research and development processes and ability to gain command of process details?Demonstrated knowledge of global and local regulatory requirements?Demonstrated understanding of key operational elements of clinical research (e.g., site selection, monitoring, data acquisition and cleaning, reporting, etc.)?Demonstrated knowledge in disease and technical areas pertaining to clinical studies, including knowledge of company direction, investigational product(s), and associated development plan(s)?Demonstrated ability to participate and support sponsor regulatory interactions/inspections?Demonstrated knowledge of the processes around protocol design and feasibility assessment?Demonstrated understanding of region/country, culture, and medical practice and how they affect clinical trial delivery?Proven ability to work in a matrix team environment with the ability to influence, drive / lead and work through others for successful delivery of clinical trial?Ability to evaluate, interpret and present complex issues and data to support risk management and mitigation?Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization?Availalbity to travel within region and/or globally as requiredORGANIZATIONAL RELATIONSHIPSProvide the primary groups or key role(s) that this role will have interaction with as a regular part of the Job responsibilities. Include any external interactions as appropriate.?Reports to Director of Clinical Site Management?Partners with local Medical Affairs and colleagues at country and regional level?Partners with Study Team e.g. Clinician, Study Manager, Data Manager, Planner?Partners with Feasibility Center of Excellence as needed?Partners with contracted organizations, and site monitor/clinical research associate (CRA)?Partners with Regulatory Affairs, PharmSci, MQA, Legal, rug Safety Unit as needed?When necessary, represents GCSM as the single point contact on the Study Team for the Regional Clinical Site LeadRESOURCES MANAGEDSummary of resources managed. 职能类别： 药品生产/质量管理

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