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Study Start-Up Manager/ SSU PM
25-30K/月上海市-上海/本科及以上/5-10年
郭磊一周前来过
北京诺华制药有限公司
职位详情
岗位职责
About the role: We are seeking a Study Start-up stage project manager for study planning, SSU activities and activation deliverables of assigned projects in compliance with Novartis processes. Leads all SSU activities of assigned projects in close collaboration with SSO Feasibility Manager and SSO Site Partnership Manager as well as the global study team.
Key Responsibilities: (Editable Section unique to each role)
· Supports country SSU strategy in close collaboration with SSO Study Start-Up Team Lead, SSO Country Head Portfolio / SSO Cluster Head Portfolio. Collaborates with SSO Country / Cluster Head Portfolio, SSO Portfolio Team Leads and global study team to ensure SSU timelines and deliverables are met according to country commitments
· Accountable for timely start-up activities from country allocation until Green Light (ready to initiate site millstone) in assigned projects. Ensures close collaboration with local IRBs/IECs and Health Authorities, as applicable. Ensures that study start-up activities are conducted and completed on time, including preparation of IRB/IEC submission packages, review of Informed Consent Forms, engaging Regulatory Affairs/CTA Hub for Health Authorities submissions, as required
· Prepares and finalizes local submission package for submission to IRB/IEC, CTA Hub (Europe: acc. to new EU-CTR) as well as Health Authorities as applicable (including subsequent amendments, IBs, DSURs, CSRs). Coordinates timely response to deficiency letters in close collaboration with local and global stakeholders. Coordinates reportable events and notifications to IRB/IEC and Health Authorities as applicable
· Accountable for timelines, accuracy, and quality of country TMF documents in study start-up to ensure TMF inspection readiness. Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements. Implements innovative and efficient processes which are in line with Novartis strategy
· Supports study feasibility in close collaboration with Feasibility Manager and Site Partnership Manager as well as the global study team. Leads site selection in collaboration with Portfolio Team Lead and Clinical Project Manager if already assigned. In satellite countries oversees local vendor selection and performance as needed. Serves as main contact for quality/compliance issues in SSU phase, escalating as necessary
· Ensures sites are prepared for “Green Light” and ensures all documentation is in place for initial and subsequent drug release. Responsible for review and sign off of the site “Green Light”
· Oversees local SSU team activities in assigned studies to achieve start-up timelines and quality execution, (proposing and implementing corrective actions where appropriate), according to Novartis standards and local and international regulations
· Leads/chairs local SSU team meetings in assigned studies, participates in global study team meetings, as required. Leads the development of country site initiation and patient enrolment plans together with SSU CRA, CPM and SSU Lead
Essential Requirements:
· A degree in scientific or health discipline required and advanced degree with clinical trial experience and/or project management, is preferable. Fluent in both written and spoken English, local language as needed
· Minimum 5 years’ experience in clinical operations in a role that oversees (project management) and/or with monitoring clinical trials
Capable of leading in a matrix environment, without direct reports
· Understanding of all aspects of clinical drug development with particular emphasis on trial set-up, execution, and monitoring
· Strong project management capabilities with demonstrated ability to problem solve and mediate complex issues
· Thorough understanding of the international aspects of drug development process, including strong knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/National Health Authorities regulations and Novartis standards
Desirable Requirements:
· Thorough understanding of the international aspects of drug development process, including strong knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/National Health Authorities regulations and Novartis standards
· Strong interpersonal, negotiation and conflict resolution skills; Communicates effectively in a local/global matrixed environment
Why Novartis:
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and tru ste d medicines company in the world. How can we
achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us!
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse
teams representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network.
Key Responsibilities: (Editable Section unique to each role)
· Supports country SSU strategy in close collaboration with SSO Study Start-Up Team Lead, SSO Country Head Portfolio / SSO Cluster Head Portfolio. Collaborates with SSO Country / Cluster Head Portfolio, SSO Portfolio Team Leads and global study team to ensure SSU timelines and deliverables are met according to country commitments
· Accountable for timely start-up activities from country allocation until Green Light (ready to initiate site millstone) in assigned projects. Ensures close collaboration with local IRBs/IECs and Health Authorities, as applicable. Ensures that study start-up activities are conducted and completed on time, including preparation of IRB/IEC submission packages, review of Informed Consent Forms, engaging Regulatory Affairs/CTA Hub for Health Authorities submissions, as required
· Prepares and finalizes local submission package for submission to IRB/IEC, CTA Hub (Europe: acc. to new EU-CTR) as well as Health Authorities as applicable (including subsequent amendments, IBs, DSURs, CSRs). Coordinates timely response to deficiency letters in close collaboration with local and global stakeholders. Coordinates reportable events and notifications to IRB/IEC and Health Authorities as applicable
· Accountable for timelines, accuracy, and quality of country TMF documents in study start-up to ensure TMF inspection readiness. Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements. Implements innovative and efficient processes which are in line with Novartis strategy
· Supports study feasibility in close collaboration with Feasibility Manager and Site Partnership Manager as well as the global study team. Leads site selection in collaboration with Portfolio Team Lead and Clinical Project Manager if already assigned. In satellite countries oversees local vendor selection and performance as needed. Serves as main contact for quality/compliance issues in SSU phase, escalating as necessary
· Ensures sites are prepared for “Green Light” and ensures all documentation is in place for initial and subsequent drug release. Responsible for review and sign off of the site “Green Light”
· Oversees local SSU team activities in assigned studies to achieve start-up timelines and quality execution, (proposing and implementing corrective actions where appropriate), according to Novartis standards and local and international regulations
· Leads/chairs local SSU team meetings in assigned studies, participates in global study team meetings, as required. Leads the development of country site initiation and patient enrolment plans together with SSU CRA, CPM and SSU Lead
Essential Requirements:
· A degree in scientific or health discipline required and advanced degree with clinical trial experience and/or project management, is preferable. Fluent in both written and spoken English, local language as needed
· Minimum 5 years’ experience in clinical operations in a role that oversees (project management) and/or with monitoring clinical trials
Capable of leading in a matrix environment, without direct reports
· Understanding of all aspects of clinical drug development with particular emphasis on trial set-up, execution, and monitoring
· Strong project management capabilities with demonstrated ability to problem solve and mediate complex issues
· Thorough understanding of the international aspects of drug development process, including strong knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/National Health Authorities regulations and Novartis standards
Desirable Requirements:
· Thorough understanding of the international aspects of drug development process, including strong knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/National Health Authorities regulations and Novartis standards
· Strong interpersonal, negotiation and conflict resolution skills; Communicates effectively in a local/global matrixed environment
Why Novartis:
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and tru ste d medicines company in the world. How can we
achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us!
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse
teams representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network.
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公司信息
北京诺华制药有限公司
- 上海
- 1000-9999人
- 生物制药
- 外企
- 已上市
诺华正在通过创想医药未来，改善人们的生活质量、延长人类的寿命。作为全球知名的医药健康企业，我们运用创新科学和数字化技术，在医药健康需求增长的领域创造变革性的治疗方法。在探索新药物的过程中，我们不懈创新，对研发的投资一直处于行业全球先列。在全球，近8亿患者受益于诺华产品，同时，我们持续探索更多创新方式使我们的创新疗法造福更多患者。诺华在全球拥有来自超过140个国家的约11万名员工。
诺华在中国的经营活动可追溯到200多年前。早在1886年，嘉基公司就开始在中国推广染料，此后汽巴公司与山德士公司也先后进入中国市场。1970年，嘉基公司和汽巴公司合并；并于1987 年在华成立北京汽巴-嘉基制药有限公司，这就是北京诺华制药有限公司的前身。1996年，汽巴-嘉基和山德士合并成为诺华公司诺华在中国的业务包括诺华肿瘤、诺华制药和山德士，全国建有两大生产基地，并在北京、上海和江苏设立了研发机构。从研发到生产销售，诺华以多元化的业务组合，全面服务中国老百姓的健康。目前，诺华在中国拥有8000多名员工。
