Medical Affairs Manager (APAC)招聘_丘以思（上海）医药信息咨询有限公司最新招聘信息-猎才医药网

职位描述

Job Title: Medical Affairs Manager (APAC)Job Location: Shanghai, ChinaJob Overview:Medical Affairs Manager, APAC is combined position that includes responsibilities of the Medical Monitor; Medical Advisor, Safety Physician Pharmacovigilance. Sr. MAM APAC also oversees Medical and safety/PV operations in the APAC region and supports Business Development by providing medical and scientific advice and input.Applicable functional responsibilities are:The Medical Monitor (MM), provides advisory support of medical nature with the aim to ensure the safety and well being of study participants, integrity of the project data in accordance with the clinical trial protocol/clinical study protocol (or equivalent documents), standard operating procedures (SOPs), good clinical practice (GCP), and all other applicable directives and regulatory requirements. Responsibilities include medical supervision of assigned projects (e.g. clinical trial, clinical study, Non Interventional Study, Registry study etc.) from both a medical and scientific perspective. MM provides and/or oversees medical monitoring activities including development and/or review of project-specific Medical Monitoring Plan (MMP), review of other project-specific plans, responding to medically related questions, controlling medical aspects of the questions arising at any stage of a clinical trial and maintaining medical oversight for the conduct of a clinical trial. The MM acts as liaison between the Sponsor/Client who is responsible for medical decisions made in a project, the investigational sites and the project team. To perform functions the MM may need to be available up to 24 hours / 7 days a week. Scope of responsibilities of the MM and availability time depends on the contract with particular Sponsor or it’s appropriately authorized designated person (Sponsor/Client). Medical Monitor may be employee or contractor of CPWW. All services must be provided timely (as described in MMP or other study related documents) and within assigned budget (or within allocated time).Primary Job Duties and Responsibilities:Job duties differ from project to project and are described in the contract, project-specific Plans (SMP; MMP), and/or other documents agreed with Sponsor/Client. Job duties also comprise any other tasks as defined by applicable Policies/SOPs/Work Procedures (WPs) and in general include but are not limited to the following:Medical oversight of projects to ensure applicable Policies/SOPs/WPs, Sponsor/Client directives, national and international guidelines are followed. Providing medical consultation to Sponsor/Client and project team for project activities;Maintaining availability to the sites and project team including the Sponsor/Client to ensure that medical questions or medical aspects of project-related questions (e.g. safety, general protocol questions, subjects’ eligibility, inclusion/exclusion criteria, screening, randomization, unblinding, dosing, termination and discontinuation, drug specific questions, investigational product/device related questions etc.) are answered or communicated for resolution to the appropriate Sponsor/Client’s medical resource. MM does not instruct the site how to manage a patient from medical / clinical prospective, but advises how to understand protocol and other applicable project requirements;Review laboratory results and results of study subject’s examinations;Develop / update of the written MMP, follow it and oversee following it by other team members, escalate cases of deviations from MMP;Review of project specific plans including Safety Management Plan (SMP);Review and advise on project-related documents (e.g. clinical study protocol, clinical study report, Patient Information etc.);Develop and/or review project related documents and reports, assess and interpret project results;Review medical literature in the scope of preparation of project-related documents and input for preparation of the respective documents;Review and assessment of issues related to protocol compliance incl. protocol deviation/violation, development of the corrective and preventative actions;Advice on and participation in management of protocol deviations/violations;Training CRAs and other team members on different topics including medical and/or safety aspects of the project or therapeutic area/indication;Training other medical monitors;Attendance to internal and external (include Sponsor/Client and/or non-CPWW personnel) project specific meetings (e.g. Investigator meeting, Kick-off meeting, regular calls etc.);Attendance at data review meetings (interim analysis and final data analysis);Attendance at and services related to DSMB organization and management, creation of a DSMB charter, memo preparation etc.;Medical review of subject’s data (presented e.g. in the format of listings, patient’s profile etc.) aiming for identification of non-reported AE, clearing the data, clarifying and resolving data inconsistencies, query management etc.;Participation in Determination of dose escalation;Review of Medical Coding to assure medical reasonability of the codes and re-coding items if it is appropriate;Review of the requests from Regulatory authorities and/or Ethic Committees/IRBs and related activities (preparation of responses, participation in meeting etc.) when requested;Triggering discussion, sending out notifications and performing associated activities related to the Risk/Benefit ratio changes;Assisting the site staff in recording/reporting of SAEs; SADEs and other medically important safety events;Provide input to frequently asked questions log;Maintain adequate documentation of interactions with sites, project team, Sponsor/Client and other parties involved;Provide availability (to all or any: sites, Sponsor/Client, project teams) via call-in number up to 24 hours / 7 days a week or other schedule as agreed by contract;Work closely with other functional groups and departments including but not limited to Safety/Pharmacovigilance, Project Management, Clinical Operations, Data Management, Biostatistics and QA to ensure that medical operational functions are executed effectively as per contract;All other tasks and responsibilities allocated to the job title as defined in Policies/SOPs/WPs.The Medical Advisor (MA), provides advisory support of medical nature to projects with the aim to support development of e.g. clinical trial program, clinical trial protocol or other documents.Primary Job Duties and Responsibilities:Job duties differ from project to project and are described in the contract, project-specific Plans (SMP; MMP), and/or other documents agreed with Sponsor/Client. Job duties also comprise any other tasks as defined by applicable Policies/SOPs/Work Procedures (WPs) and in general include but are not limited to the following:Provide medical advisory in the scope of feasibility evaluation of clinical trial projectsProvide medical advisory for Clinical Study Protocol (CSP), Case Report Form (CRF), Patient Information (PI), Clinical Study Report (CSR) etc.Review medical literature in the scope of preparation of document for clinical trial submissions (authority, ethics committee);Advisory for submission documents;Training of internal and external staff on different medical topics;All other tasks and responsibilities allocated to the job title as defined in Policies/SOPs/WPs.The Safety Physician Pharmacovigilance (SP PV), performs review, analysis, medical evaluation and regulatory assessment of Individual Case Safety Reports (ICSRs), supports the development of aggregate reports e.g. Development Safety Update Report (DSUR), Periodic Safety Update Report (PSUR), participates in safety signal management and provides all other activities in close cooperation with safety/pharmacovigilance and other internal and external groups as described in applicable SOPs.Primary Job Duties and Responsibilities:Job duties differ from project to project and are described in the contract, project-specific Plans (SMP; MMP), and/or other documents agreed with Sponsor/Client. Job duties also comprise any other tasks as defined by applicable Policies/SOPs/Work Procedures (WPs) and in general include but are not limited to the following:Perform medical evaluation, confirm and suggest follow-up and confirmation of regulatory assessment of Individual Case Safety reports (ICSR) from various sources (e.g. clinical trials, spontaneous, literature etc.);Identify a safety finding that would necessitate further evaluation (e.g. positive re-challenge of a SUSAR);Serve as a medical resource for the Pharmacovigilance Team for discussions related to initial classification (triage) of Individual Safety Case (ISC), ISC disposition emails, coding, causality, and expectedness assessments;Provide medical input within established timelines for case processing for regulatory and periodic reporting purposes;Communicate and/or support communication with the safety / pharmacovigilance contact person at the client’s site (where applicable);Review of aggregate safety data, adverse event reports, including review of relevant literature for safety information pertinent to product safety, as needed;Particiapte in signal management (e.g. perform and/or provide review of relevant documentation for detection and evaluation of potential signals etc.);Organise, oversee and control the safety portions of the projects (i.e. provide Project Management in safety services in clinical trials, post-marketing surveillance, and other types of projects);Assist with and/or provide input to the preparation of a Safety Management Plan (SMP) or equivalent documents;Support the development of aggregate reports e.g. Development Safety Update Report (DSUR), Periodic Safety Update Report (PSUR) in cooperation with relevant members from other groups and departments (internal and external);Assist with and/or provide input to the preparation of Risk Management Plan (RMP);Support of postmarketing surveillance based on various sources;Participation in controlling activities initiated by different parties (e.g. audits and/or inspections), as needed;Support in reporting of risks ratio changes – to the regulatory authorities or other applicable parties;Provide advice and support to sites, project teams (internal and Sponsor’s), in organization and management of safety aspects of the projects including but not limited to reporting obligations;Provide medical and safety expertise and/or training re: safety surveillance in clinical trials (e. g. SAE reporting, regulations).Additional Tasks and Responsibilities (as needed)Data Safety Monitoring Board (DSMB) – review of documents provided to DSMB, support in meeting coordination, participation in meetings;Clinical Event Committee (CEC) – providing medical support for adjudication process and participation in meetings;Responses to regulatory agencies and governments - assisting in preparing safety portions of the responses;Medical Safety Review Meeting (MSRM) – participation in and/ or chairing of the meeting;Safety Evaluation Committees – serving and contributing to the development of risk management activities;Train staff and project teams on different topics incl. procedures related to medical review and interpretation; training on specific indications or therapeutic areas etc.;Assist with and/or support for the safety aspects of all relevant study documents including, but not limited to Investigator Brochures (IB), Informed Consents, Package Labels, Core Safety Information, Protocols, Final Clinical Study Reports (CSR), IND and NDA Annual Reports, Health Hazard Evaluations, Signal Evaluation Reports, Annual Safety Reports, and Integrated Summaries of Safety (ISS) for IND/NDA submissions, etc.; Provide review and input for SOPs and Guidelines;Take part in meeting with existing and Potential Clients, Support business development activities;All other Tasks and Responsibility assigned to MM, MA and SPPV in applicable SOPs.Supervisory Responsibilities:MAM, APAC oversees Medical and safety/PV operations in the Asia and Pacific region and may act as Line Manager for the Medical and safety/PV personnel in the region according to the current organization chart and project assignments.Job Requirements:EducationMD required, MD/PhD is a plus.ExperienceMinimum 3 years of experience within the clinical arena post-training (in the pharmaceutical, biotech, medical device and/or CROs). CRO experience highly desirable.Experience working in a drug safety / pharmacovigilance or drug development environment performing medical review of clinical and post-marketing data.Prior combined experience as Medical Monitor and Medical Advisor and Safety Physician Pharmacovigilance (or equivalent roles) is highly desirable. Experience or knowledge of safety signal management approaches.Experience in project management and team leadership.;Experience in development and delivery of the trainings and presentations.Skills/CompetenciesClinical thinking: ability to perform critical review and answer questions of medical nature from sites, project team (incl. Sponsor/Client) in accordance with ICH GCP guidelines, project specific documents to ensure patient safety, data integrity and successful completion of project;Deep understanding of the scientific basis for therapies and drug-induced diseases. Comprehensive knowledge of medical device, vaccines and drug development process;Deep understanding of safety databases and pharmacovigilance processes;Effective communication: comfortable communicating both inside and outside to company;Mature Management: management with a calm, positive winning attitude and excellent decision making skills;Strong knowledge of the drug/device/vaccine development process;Regulatory guidelines expertise: knowledge of international guidelines and country specific regulatory requirements (FDA, ICH GCP, MHRA, Pharmaceuticals and Medical Devices Agency (PMDA), GVP Modules; respective EU Clinical Trial Directive etc.);Training expertise: able to efficiently train others;People management: able to clearly and efficiently communicate with site and team members;Clinical Management: able to manage clinical projects successfully;Time management: good sense of urgency, prioritization skills;Team player: effective participant as a team member and team leader;Creative and positive leadership: programming team success through establishing and clear articulation of goals;Creative problem solving skills;Effective oral and written communication and presentation skills (Mandarin and English are compulsory); Coach: a passion to assist others in becoming all they can be; Achievements: ability to define and meet requirements;Integrity: Understanding and acting on principles of honesty, trust and fairness.CapabilitiesProficient in the use of computers and clinical trial management software programs.Ability to drive an automobile and have a valid driver’s license.Must have a credit card that can be used for travel expenses.Ability to work remotely.Ability to travel up to 20 %, as needed.THE COMPANY WILL NOT ACCEPT RESUMES FROM THIRD PARTY VENDORS 职能类别：医药技术研发人员临床研究员关键字： MM MA SP PV

公司信息

In Jan 2014,Choice Pharma(丘以思(上海)医药信息咨询有限公司) merged with Clinipace Worldwide. Clinipace Worldwide is a global full-service digital contract research organization (dCRO) that has pioneered an innovative service model to transform drug and medical device development by delivering technology-amplified services to improve study performance, collaboration, and transparency across all stakeholders. From managing your entire development program to conducting an individual clinical trial, our experts bring extensive therapeutic and local experience in building a well-defined clinical plan to maximize your success. Powered by TEMPO? – our proprietary eClinicaltechnology – our teams ensure your success and bring unsurpassed efficiency, quality, and visibility to your development programs. Now Clinipace Worldwide ranks the 10th CRO,and developes rapidly. Clinipace Worldwide，一个基于科技的全球性全方位服务的数字化合同研究组织（dCRO）。我们开创性的开发了依靠技术创新的CRO服务模式，以满足风险投资支持的，中型的战略性制药，生物技术公司以及医疗器械公司的研发需求。借助于我们专有的TEMPO?电子化临床试验平台，我们的专家团队用他们丰富的治疗领域知识和见解来帮助生命科学公司制定和执行注册策略，临床开发和上市后研究，以确保药物和医疗器械开发计划的成功。 Clinipace Worldwide的唯一目标就是通过开拓创新的技术继续坚定不移地致力于客户的成功，以最具性价比的全球性解决方案服务客户，提供高透明度，灵活和高质量的服务。我们已经开展了超过1500个全球性的临床研究，完成了超过300个注册和开发策略制定项目。治疗领域涵盖如心血管和代谢，中枢神经系统，皮肤，消化，免疫，感染，肾脏，肿瘤，呼吸，风湿和疫苗（和其他细胞和组织疗法）。 Clinipace Worldwide刚刚庆祝了他们的10週年。如今，Clinipace Worldwide其总部设在美国北卡罗莱纳州的Research Triangle Park，为横跨4大洲的27个国家提供服务。因为对更高的数据准确度，经济高效的解决方案和更低的研发成本的需求在不断的增加，Clinipace Worldwide还在持续的在全球扩张。 https://www.clinipace.com 最后, 丘以思以正直透明、追求卓越绩效的企业文化邀请您的加入. 应聘邮箱：mwang@clinipace.com

周边城市招聘：上海浙江安徽广东山东河北重庆北京江苏湖南

企业入驻日期： 2017-11-09

上海相关职位

职位描述

联系方式

公司信息