(Senior) Regional Clinical Study Manager

Job Description General Description: Accountable for regional study delivery with appropriate inspection readiness quality, within agreed timelines and budget Leads the regional clinical operations team (including oversight of external partners working on the regional level) and acts as point of escalation for resolution of issues within the region for the assigned study Ensures alignment of regional deliverables with overall study goals Essential Functions of the job: Regional Leadership Leads the regional clinical operations team effectively, ensures effective decision making and acts as point of escalation for resolution of issues within the region for the assigned study Leads external vendors involved in study delivery on a regional level Collaborates with key stakeholders in the region and provides regular updates on study progress in the region to senior management and Global Clinical Study Manager as required Represents the regional study team at internal meetings and at the cross-functional Clinical Study Team (CST) meetings Leads regional operations meetings with all regional study team members Timelines, Planning and Execution Leads planning and management of the assigned clinical study(ies) from feasibility through closeout activities for region, in line with global study timelines Generates, manages, and maintains high quality study start up and recruitment timelines for region and tracks progress towards these Ensures that the clinical study is operationally feasible in the region, drives trial feasibility, country allocation and site selection process for assigned region in collaboration with feasibility managers, country heads, medical affairs and any other stakeholders Provides regional input on global study plans as required Ensures timely availability of local adaptations of global study documents such as informed consent forms, in close collaboration with other key stake holders to ensure timely submission to regulatory authorities and ECs/IRBs Accountable for submissions of study in countries in assigned region in close collaboration with regional study start up team and regulatory affairs Ensures regional and country information in study systems and tools is entered and up to date Collaborates closely with CRAs in the region to ensure proper study execution at the sites. Reviews and signs-off monitoring reports Responsible for working with regional and country teams to ensure that country and site level Trial Master File is created, maintained and QC’d on a regular basis as per the study TMF QC plan Provides input to Global Clinical Supplies regarding drug inventories in region and reviews local drug labels for region. Provides input on local regulatory approval and reimbursement status of comparator drugs used in study for countries in region Manages the trial data collection process for the region, drives data entry and query resolution As required, supports planning and execution of the Clinical Study Report in collaboration with Global Clinical Study Manager and Medical Writing Quality: Handles escalated issues or problems with the sites in region in close collaboration with stakeholders such as country heads Monitors study activities in region to ensure compliance with the study protocol, SOPs, ICH/GCP and all other relevant regulations Ensures inspection readiness for study in region at any point in time throughout the study life cycle Informs Global Clinical Study Manager of any issues arising on the study, evaluates impact and ensures solutions are implemented Prepares sites for quality assurance audits and inspections, drives responses to audit and inspection findings as appropriate Collaborates with CST members and colleagues to ensure cross-team, site learnings, and best practices are shared Leads improvements and partners with CST members to enhance the efficiency and the quality of the work performed on assigned studies Contributes to development, optimization and review of work instructions and SOPs as required Budget and Resources Works with the sourcing team to select and manage regional study vendors Manages regional study budgets Works closely with Clinical Business Operation on investigator fees, site payment issues and patient travel reimbursement activities Identifies and manages regional team resource needs and establishes contingency plans for key resources Monitors regional resource utilization over study life cyle and liaises with functional managers as needed Supervisory Responsibilities: Provides performance feedback on team members as required Might mentor junior team members Competencies: Communicating Effectively Embracing Change Driving Excellence Working in Teams Mentoring Learning Education Required: Bachelor’s Degree in a scientific or healthcare discipline required*, Higher Degree preferred *exceptions might be made for candidates with relevant clinical operations experience Computer Skills: MS Office, Project Planning Applications Other Qualifications: Proven experience in clinical research including relevant experience as team lead in clinicial functions Experience as CRA is preferred Travel: Travel might be required as per business need 百济神州全球胜任力 当我们通过以下十二项全球胜任力，展现出 "患者为先"、"无界协作"、"锐意创新 "和 "追求卓越 "的价值观时，我们就能帮助全世界更多患者获得更多负担得起的药品。 ●团队协作 ●提供并征求坦诚及可行的反馈 ●自我认知 ●兼容并蓄 ●积极主动 ●开拓精神 ●持续学习 ●拥抱变化 ●结果导向 ●分析性思维/数据分析 ●卓越财务 ●清晰沟通 BeOne Global Competencies When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. ●Fosters Teamwork ●Provides and Solicits Honest and Actionable Feedback ●Self-Awareness ●Acts Inclusively ●Demonstrates Initiative ●Entrepreneurial Mindset ●Continuous Learning ●Embraces Change ●Results-Oriented ●Analytical Thinking/Data Analysis ●Financial Excellence ●Communicates with Clarity 求职者隐私申明： 百济神州致力于尊重和保护您的个人信息权利，并承诺依据合法、正当、必要和诚信的原则处理您的个人信息（包括个人敏感信息 ）。 由于百济神州在全球范围内开展业务，我们可能需要基于人力资源管理等合理业务目的而将您的个人信息发送和/或存储在位于您所在国家以外其他国家（例如：美国）的服务器和数据库中，详情参见百济神州《求职者隐私政策》（百济神州官网 - 隐私政策 - 求职者隐私政策）。 如您主动向我们提供您的简历信息或其他个人信息，则视为您已经充分理解并确认接受百济神州《求职者隐私政策》内容。如您对此有任何疑问的，请勿提交简历信息或其他个人信息。 BeOne is committed to respect and protect your personal information rights, and will process your personal information, including your sensitive personal information, based on the principles of legality, legitimacy, necessity, and integrity. 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