职位描述

职位描述： Role Summary:The Senior Study Manager is responsible for simultaneous delivery of the operational aspects of a number of single/multiple countries clinical studies from protocol development through effective study reporting and close-out; submission activities; and audits/inspections, as appropriate.The Senior Study Manager achieves this purpose by thoroughly understanding and actively managing the activities and deliverables of all study conduct partners (e.g., Research/Business Units (RU/BU), Site Management functional lines, Pharmaceutical Sciences, GCDS, CRO/SMOs, investigator sites, vendors) and by proactively identifying and managing issues.The Senior Study Manager is accountable for study delivery and manages study deliverables through internal and external resources.Organizational Relationships:Reports to Study Management Lead.Partners with the Clinical Project Manager, Site Management functional lines and Clinical Trial Assistant.Partners with other Development Operations and non-Development Operations functions including but not limited to Clinical Trial Support and Compliance, Clinical, Regulatory, Pharmaceutical Sciences, Finance and Procurement, Legal, etc.Resources Managed (budget and FTEs):?Components of study budget, including but not limited to investigator grants, lab costs, vendor costs, clinical supplies, and investigator meeting costs etc.Responsibilities:Across Entire Study:?Actively manages the activities and deliverables of all study partners (e.g. RU/BU, Investigator sites, site management functional lines, Clinical Trial Support and Compliance, Pharm Sci, GCDS, CRO/SMOs, vendors) to ensure timely delivery of quality data on multiple studies.?Effectively manages and leads external vendors to deliver key clinical operations milestones for outsourced studies.?Oversees site management functional lines to ensure that protocol and monitoring plan are consistently and appropriately implemented across investigator sites and countries. Collaborates with the sites and site management functional lines to ensure that they are provided with the information to effectively contribute to the study.?Proactively identify and resolve study operations-related issues as they arise.?Responsible for ensuring that the operational aspects of a clinical study meet time, quality & cost targets consistent with the Clinical Development Plan and China new product development strategy.?Responsible for ensuring that studies are conducted in compliance with GCP, relevant SOPs, and regulatory requirements; Responsible for inspection readiness for all aspects of the study conduct.?Assist Clinical Project Manager to develop project plans and implement resource strategies to achieve RU/BU project goals, including contingency planning and risk mitigation strategies, to ensure successful delivery of study goals.?Share best practices across the organization to ensure cross-line standardization.?Support the efficient implementation and utilization of globally agreed, processes, technologies and strategies (e.g. OC-RDC, Datalabs, IMPALA, etc.) to ensure consistent processes are used across studies.?Coach and mentor Study Managers/ senior CRAs /lead CRAs as appropriate.Study Start-upProtocol Development?Provides input to the core protocol elements (CPE) (as early as the concept stage, if appropriate) to ensure operational feasibility.?Responsible for conducting the protocol feasibility prior to finalization of the CPEs, as appropriate.?Provides input to the study management components of the protocol;?Produces study level ICD, as appropriate.Budget?Provide input to the generation of investigator grant budgets at the study level (identify required budget components).?Initiate, review and ensure approval of the study start-up budget, including per subject and ancillary investigator costs, and Clinical Trial Budget (or MPA).Data Management/GCDS Interactions?Partner with GCDS to ensure set up of data capture tools (CRFs, EDC system, diary cards, questionnaires, translations etc.) to ensure completion within project deliverable timelines.?Overall responsible for ensuring the study has efficient and effective data flows (for all types of study data, including SAEs, endpoints, patient diaries, lab data, etc).Subject Recruitment/Country Allocation/Site Selection/Start-up (as appropriate)?Conducts study level allocation including country and study level feasibility assessments to ensure appropriate country and study site selection.?Develops study level recruitment/retention strategy/plan; oversee implementation of plan, including site-level plans, recruitment/retention tools, and advertising materials.?Oversees sites and site management to ensure timely site selection and site readiness (Clinical Site Agreements, Ethics Committee approvals and regulatory documentation.)Training/Investigator Meeting (as appropriate)?Develops the Monitoring Plan; ensure sites and site management functional lines are trained on Protocol-Specific aspects of the Study Monitoring Plan.?Responsible for working with Clinician to ensure that site management functional lines are provided with appropriate training in both the protocol and therapeutic area.?Drives and/or contributes to investigator meeting strategy/agenda and responsible for overseeing implementation by the project team; review meeting objectives/materials.?Facilitates and presents at investigator meetings, as required by project team.Drug Supply?Collaborates with CPM and Supply Chain Lead to develop and complete of the Request for Clinical Supplies.?Works with the Supply Chain Lead to ensure that clinical trial drug supplies are ordered, produced, labeled and supplied in a timely manner.Communications and Tracking Deliverables?Tracks progress to ensure all essential study materials, equipment and documentation are in place for study start (e.g., ethics and regulatory approval, budget, drug supplies, data collection tools).?Communicates status to Clinical Project Manager and project team as appropriate.Clinical Study ConductSubject Recruitment/Retention?Manages protocol-level subject recruitment and retention and take action to ensure targets are met.Quality & Compliance Management?Periodically review protocol deviations and collaborate with clinicians to manage protocol deviations according to Pfizer SOP.?Works closely with project team to ensure data quality requirements are agreed to and met, prior to reporting.?Performs required activities to ensure quality and completeness of Trial Master File and any additional regulatory documentation.?Works with quality assurance line to establish appropriate QC, audit and inspection plans. Serves as central point of contact for site and sponsor audits. Supports the writing of appropriate audit responses and ensures actions are completed.Data Flow Management?Partners with GCDS and site management functional lines to ensure timely retrieval and database entry of CRFs and other clinical study data and the distribution and resolution of data queries.?Coordinates endpoint collection, reconciliation and adjudication, when required.?Coordinates data collection and cleaning for interim data locks (e.g., DSMBs, Planned interim analysis, Final Safety Updates, etc)CRO/Vendor Management?Supports project team in the effective management of external vendors including SMOs and CROs.Budget?Compiles components of protocol level budget.?Approve up front or initial payments to investigators and vendors.Drug Supply?Works with Supply Chain Lead to ensure drug supply (including resupply) process timelines, risks and issues are handled in a timely manner.Communications and Tracking Deliverables?Uses the production and tracking of metrics as a tool to monitor report on and actively manage the delivery of project team goals.?Monitors cross-site performance and raise issues with sites and site management functional lines.?Responsible for distribution of information regarding the study at the protocol level to site management functional lines and investigational sites as appropriate.?Works with site management functional lines to ensure investigational sites are fully informed of all study related information in a timely manner.Clinical Study Close-out?In close partnership with the sites and site management functional lines to ensure site closeout activities are completed.?Responsible for the collection and consolidation of the Protocol Deviation Logs.?Accountable for study close out; support GCDS in database lock and release activities, ensuring all timelines and quality goals are met.?Contributes information regarding study conduct, as required, to ensure effective and timely study reporting. Participates in review of study report, as appropriate.Qualifications (Training, Education & Prior Experience):?Minimum of BS/BA in a biomedical discipline or equivalent education/training is required?At least 7 years in clinical practices?Good working knowledge of Chinese/ICH GCP guidelines and Pfizer SOPs?Knowledge on drug development process and country regulatory environment?Experience with clinical research methodology (e.g., study design, study monitoring and data analysis). Prior study management and/or study coordination experience preferred. Demonstrated effectiveness in working in a multidisciplinary, matrix team situation.?Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.?Advanced education and/or training/experience desirable. 职能类别： 临床研究员

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