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Senior Manager, Site Operations Expert, Clinical Site Management

beigene · 上海市, 上海市, 中国

External listingfull-timeabout 2 months ago

About The Role

General Description: Hire, train, and develop the Site Operations Expert (SOE) team, ensuring a highly qualified and capable team to execute site engagement strategies in alignment with BeiGene’s corporate objectives and strategies. Ensure the SOE team’s proficiency and compliance with processes and requirements of assigned hospital, continuously driving efficiency and accelerating study delivery across all therapeutic areas within the assigned region. Strengthen BeiGene’s reputation and expand its influence at clinical trial sites, positioning the company as a preferred partner for clinical research. Oversee SOE team performance by managing key performance indicators (KPIs) and ensuring the execution of clinical deliverables in strict adherence to ICH guidelines, GCP, local regulations, and applicable SOPs. Essential Functions of the job: Allocation and conduct ing of trials Develop in-depth expertise on the performance and specific requirements of each hospital within the region, categorizing hospitals based on BeiGene’s defined criteria. Strategically allocate SOE resources to BeiGene cooperated hospitals according to the designated hospital tiering system. Ensure SOE teams execute tailored site engagement strategies at each assigned hospital, aligning with BeiGene’s corporate objectives and strategic priorities. Monitor clinical trial progress and key deliverables (e.g., site start-up, patient recruitment) to drive efficiency across all study phases, from feasibility and initiation to enrollment, maintenance, database lock (DBL), and site closure. Implement mitigation plans as needed to address challenges. Strengthen BeiGene’s relationships with clinical sites, ensuring high site performance and reinforcing BeiGene’s reputation as a trusted and successful partner in clinical trial execution. Productivity Manage and regularly review SOE assignments and workload, making adjustments and implementing mitigation plans as needed to optimize efficiency. Identify and develop new clinical trial site partnerships, expanding the number of Tier 1 and Tier 2 sites in accordance with BeiGene’s quality standards. Streamline site performance management by reducing the number of low-performing sites and minimizing non-enrolling sites to enhance overall trial productivity. Delivery, Quality and Compliance Regularly review hospital performance within the region based on aligned KPIs, analyze performance gaps, and develop and implement improvement strategies. Monitor SOE team performance and provide support in issue resolution to ensure clinical trial execution aligns with protocol requirements, regulatory guidelines (ICH-GCP). Ensure effective risk management and timely issue escalation and resolution. Identify SOE team competency gaps and enhance capabilities through targeted training programs. Execute the Accompany Site Visit per SOP requirements and complete the report in a timely manner. Escalate the study related findings to rCSM for awareness and taking actions for solution. Ensure SOE team adherence to SOPs and completion of all required training curricula to maintain compliance and operational excellence. Oversee study implementation and milestone delivery in close collaboration with Clinical Research Associates (CRAs) to ensure seamless execution. Conduct regular performance reviews and evaluations of the SOEs, assessing key metrics such as quality, delivery, compliance, 360-degree feedback, and task completion. Driving Excellence Inspire and support the team in embracing change with a positive mindset, ensuring flexibility and preparedness to navigate its impact effectively. Foster an environment of innovation and inclusivity, where diverse perspectives are valued, and team members feel empowered to share ideas. Supervisory Responsibilities: People Management Lead and manage direct and indirect reports in alignment with the organization’s policies and applicable regulations. Hire, train, develop, and retain talent by designing comprehensive recruitment plans, organizing in-depth training sessions, and creating structured career development paths to enhance engagement and retention. Coach and mentor employees by assigning role-specific training, encouraging the adoption of new technology tools, and promoting a culture of continuous improvement. Ensure optimal resource allocation by assessing qualifications and workload distribution, ensuring efficiency across the team. Establish clear performance metrics, conduct regular evaluations, and provide constructive feedback to drive continuous improvement. Monitor SOE performance, including KPIs, process efficiency, recruitment commitments, and systematic issue resolution, offering continuous guidance to ensure high-quality output. Address employee relations issues promptly and fairly, fostering a harmonious work environment through active listening and conflict resolution. Conduct performance reviews and guide team members in improving efficiency, prioritization, and overall performance while fostering professional growth. Ensure fair and objective decision-making in all human resources matters, maintaining a balanced and transparent evaluation process. Provide performance feedback on team members as needed. Leadership Make effective decisions with confidence, take ownership of outcomes, and stand by choices when challenged. Proactively plan and prioritize work to ensure timely execution of projects, demonstrating initiative and a strong sense of urgency. Competencies: Ethics: Treats people with respect; inspires the trust of others. Works with integrity and ethically and upholds the organizational values. Fosters Teamwork : Proactively facilitates teamwork and creates a positive and inclusive work environment; puts BeiGene’s and patients’ interests ahead of one’s individual or functional interests; values the opinions of others. Provides and Solicits Honest and Actionable Feedback: Holds ongoing conversations with team members about their performance; solicits feedback from others on one’s own performance and takes action on that feedback. Self-Awareness : Exhibits emotional intelligence and self-control; builds positive relationships; is aware of one’s behavioral strengths and weaknesses as a leader; acts respectfully and empathetically to others and holds others accountable for the same. Acts Inclusively : Fosters diversity and leads inclusively; actively seeks and engages with diverse perspectives; identifies and mitigates bias and addresses barriers to inclusion; promotes a sense of belonging across different cultures, teams and matrixes. Demonstrates Initiative : Makes bold commitments and delivers against them for both self and team; action-oriented; acts decisively and empowers others to make sound decisions; anticipates and proactively addresses challenges. Entrepreneurial Mindset : Challenges the status quo; identifies and fosters opportunities for innovation and improvement; establishes a safe and encouraging environment for innovative ideas; encourages calculated and measurable risk-taking; always balances risk with reward. Continuous Learning : Identifies opportunities for continuous learning; challenges oneself and others to be better; exhibits curiosity and encourages the same for the team; aids in team’s development and supports the team to achieve their development goals. Embraces Change : Encourages and supports change; helps others manage through change positively; challenges others to be adaptable and flexible. Results-Oriented : Prioritizes and directs resources towards what’s important for the enterprise, not just oneself or one’s team/function; relentlessly sets and achieves outcome-based goals with integrity and following compliance standards for self and team;acts with a sense of urgency and agility; able to influence and drive results even without direct authority in a matrix environment. Analytical Thinking/Data Analysis : Identifies and analyzes data from a variety of sources to derive insights, identify root causes and generate solutions; makes well-considered decisions. Financial Excellence : Drives effective use of Company resources to deliver results; leverages internal capabilities where possible; instills ownership and responsibility for sound financial decisions; always seeks value for money. Communicates with Clarity : Communicates clearly and in a timely manner with cultural sensitivity; provides context, rationale and expectations; checks for understanding; listens effectively and responds to feedback; communicates effectively across matrixes. Qualifications: Minimum of three years of experience as a People Manager or in a similar role, with a strong understanding of clinical trial processes and a thorough knowledge of ICH GCP guidelines and applicable regulations. Experience in a multinational company or global CRO is preferred. Proven ability to manage KOLs in the region with a track record of successful KOL relationship management and satisfaction. Excellent interpersonal skills, organizational skills, and strong communication skills, with demonstrated team leadership capabilities. Proficiency in English with strong verbal and written communication skills. Therapeutic or medical knowledge is a plus. Experience in study management and vendor management is an advantage. Travel: Be adaptable to business trips as needed. Education Required: Bachelor’s degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences or drug development is required. 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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