Global Study Lead
6 months ago
RESPONSIBILITIES:
Lead and coordinate a cross-functional study team of experts in accordance with STOM and its roles, accountabilities and responsibilities framework (RACI) to ensure the clinical study progress as planned driving achievement of milestones according to timelines, budget and quality standards Lead and facilitate communication across all functions and provide guidance and support to the core and extended study team members as needed and in accordance with study-specific communication plan For outsourced studies, be the primary AZ point of contact for the CRO Project Manager to ensure study delivery according to agreed upon timelines, budget and quality standards, while ensuring that the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study, in accordance with relevant AZ SOPs and guidelines ( description of services and transfer of obligations) Provide input into and hold accountability for the development of essential study level documents ( Clinical Study Protocol (CSP) through to Clinical Study Report (CSR)) in accordance with relevant AZ SOPs Ensure all external service providers ( central laboratories, IXRS, ePRO, etc.) engaged at the study level are performing to contracted goals and timelines/budget and that adequate oversight is documented Develop and maintain relevant study plans ( global study management plan and its relevant components such as study project plan SPP) including required input into study level quality and risk management planning ( risk-based quality management, proactive risk and contingency plans, etc.) ensuring that the risk response strategies and issue escalation pathways are clear to the entire study team Oversee study level performance against agreed upon plans, milestones and key performance indicators (KPIs, quality and operational) by using company tracking systems and project timelines ( SPP, data flow metrics dashboard, CTMS or eTMF dashboard) and communicate any risks to timelines and/or quality to CPT, along with proposed mitigations Identify and report quality issues that have occurred within the study in accordance with relevant AZ SOP and collaborate with all functions as necessary to overcome barriers and achieve milestones; proactively communicate findings and corrective action plans (CAPAs) to relevant stakeholders ( CPT, quality assurance staff, functional line management, etc.) Oversee Trial Master File (TMF) completion in accordance with relevant AZ SOPs, including ensuring the TMF plan and Expected Document List (EDL) are in place and that QC activities are performed on an ongoing basis to ensure TMF completeness at all times Ensure timely compliance with company-wide governance controls ( Delegation of Authority, Sunshine Act, ACCORD attestations, Clinical Trial Transparency) The GSL is responsible for study budget re-forecasting following initial budget estimate provided by the CPT and accountable for study budget management through the study lifecycle and for providing budget progress reports to the CPT including any financial risks and mitigation plans (as part of the ongoing study change control process) Ensure studies are inspection-ready at all times, according to ICH-GCP and AZ SOP and relevant policies/guidelines; GSL is the primary Study Management & Operations (SMO) point-of-contact in the event of an audit or inspection Provide regular feedback on individual performance to the study team members and their line managers to support their professional development; may mentor less experienced colleagues Work on non-drug project work such as SMO representative in process improvements and/or leading improvement projects as discussed and agreed upon with their managerREQUIRMENTS:
University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research 7 years of relevant clinical experience in R&D in the pharmaceutical industry , including 2 years’ project management experience , or equivalent combination of education, training and experience Extensive knowledge of clinical research regulatory requirements and demonstrated abilities in clinical study management processes and clinical/drug development Demonstrated solid project management skills and knowledge of relevant tools Strong, demonstrated abilities/skills in team leadership Strong abilities in establishing and maintaining effective working relationships with internal and external co-workers and stakeholders, along with strong conflict management skills Excellent communication and interpersonal skills Strong strategic and critical thinking abilities Strong organizational and problem-solving skills Ability to manage competing priorities
【AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.
阿斯利康是一家提供平等机会的企业，我们将考虑所有符合条件的求职者就业。不因残疾、性别或性取向、怀孕或产假状况、种族或民族或族裔出身、年龄、宗教或信仰、性别认同或变更、婚姻或伴侣关系、受保护的退伍军人身份（如果适用）及任何其他受法律保护的特征而产生歧视。】
Date Posted
26-4月-2024Closing Date
29-9月-2024-
Sr./Associate Director, CPM
6 months ago
Daxing District, China AstraZeneca Full timeBe responsible for the on time, quality, within budget delivery of global and local medical affairs clinical study and program for key products Prepare and deliver study level feasibility, and develop recruitment strategies , and the delivery of the approved Clinical Study Protocol .The job holder will lead a team to develop and deliver study results and...
-
Physician Director
6 months ago
Daxing District, China AstraZeneca Full timeResponsible for products’ clinical development strategy and plan in multiple disease areas in R&D China. Responsible for managing reginal or China therapeutic or research projects or acting as an expert involved in the design, conduct, monitoring, data interpretation and reporting of individual clinical trials. Will provide some input to medical science...
-
Daxing District, China AstraZeneca Full timeRESPONSIBILITIES Leading the planning/execution of portfolio projects and programs in CNPTs Responsible for the development of strategic options for a project Responsible for coordinating the creation of project plan (business case, cross-functional development plans, budget and timeline), and project plan update and maintenance Responsible for...
-
Global Cost Optimization Expert
3 weeks ago
Jiading District, China A2MAC1 Full timeJob Title: Costing & Insights Engineer (Exterior)Job SummaryAs a Costing & Insights Engineer (Exterior) at A2MAC1, you will play a key role in optimizing product development costs and improving engineering solutions. You will work closely with cross-functional teams to understand the latest cost-efficient engineering solutions, collaborate with OEMs and...
-
(Sr.) Manager, Regulatory Affairs-CMC
6 months ago
Daxing District, China AstraZeneca Full timeAs a Regulatory CMC Expert, this role is responsible for assisting RA CMC Director to develop and communicate CMC regulatory strategy based on understanding of local CMC regulations, involved in CMC regulatory project, providing the support and coordination on CMC dossiers preparation, submission and response; providing technical support and tactical...
-
Global Electronic Sourcing Specialist
5 days ago
Yangpu District, China Continental Full timeJob DescriptionWe are seeking a highly skilled Global Electronic Sourcing Specialist to join our Electronics Purchasing Category Management team at Continental.This role involves driving and shaping current developments in the car industry, focusing on increasingly higher portions of electronic components in modern cars.The successful candidate will lead...
-
Changning District, China Maquet (Shanghai) Medical Equipment Co., Full timeJob DescriptionWe are seeking a seasoned professional to fill the role of Global Quality and Regulatory Affairs Leader in East Asia, based in Shanghai, China. As part of our commitment to excellence, this individual will lead our quality and regulatory affairs efforts in the region.About the RoleThis is an exciting opportunity for a talented and experienced...
-
Global Sourcing Director
3 weeks ago
Minhang District, China Centric Brands Full timeAbout UsCentric Brands is a leading lifestyle brand collective that designs, sources, markets, and sells high-quality products in multiple segments, including women's, men's, and kid's apparel, accessories, entertainment, and beauty. Our company is focused on our customers and our brands that will drive the company's future growth. We are defined by...
-
Segment Development Manager
4 weeks ago
Xuhui District, China Avery Dennison Smartrac Full timeAbout the RoleAvery Dennison Smartrac is seeking a highly skilled Segment Development Manager to drive the development pipeline for leading brand owners and streamline the value chain to realize sales. As a key member of our team, you will influence EU decision-making processes, provide value-added services, and promote sustainability thought leadership.Key...
-
Yangpu District, China Continental Full timeCompany OverviewContinental is a leading manufacturer of tires, automotive systems, and industrial products. We are seeking a skilled Senior PR and Brand Communication Specialist to join our team in China.Job DescriptionThis role will focus on developing and managing brand image, building and maintaining a positive company image through stakeholder...
-
Packaging Innovation Manager
5 days ago
Xuhui District, China Avery Dennison Smartrac Full timeAbout Avery Dennison SmartracA global materials science and digital identification solutions company that provides a wide range of branding and information solutions optimizing labor and supply chain efficiency, reducing waste, advancing sustainability, circularity and transparency, and better connecting brands and consumers.We serve an array of industries...
-
Costing and Insight Engineer
3 weeks ago
Jiading District, China A2MAC1 Full timePosition Overview:A2MAC1 is seeking a talented Costing & Insight Engineer (PWT) to join our team. As a key member of our product development team, you will be responsible for analyzing and optimizing product costs.Key Responsibilities:Understand the latest cost-efficient engineering solutions through technical benchmarking.Cooperate with OEMs or Tiers to...
-
Jiading District, China A2MAC1 Full timeJob DescriptionWe are seeking an experienced Advanced Engineering Cost Analyst to join our team at A2MAC1.The successful candidate will be responsible for analyzing and optimizing the cost of high-performance vehicle products, working closely with OEMs and Tier suppliers.This is a challenging and rewarding role that requires strong technical skills,...
-
Costing & Insights Engineer(Exterior)
2 months ago
Jiading District, China A2MAC1 Full timePosition Value1.Understand latest and cost-efficient engineering solution through technical benchmark2.Learn the engineering excellent practices from high-performance vehicle products across the world3.Co-work with OEM or Tiers to attend in new product development phase4.Communicate with global technical or costing experts5.Utilize technical insights...
-
Interior Costing Insights Engineer
2 months ago
Jiading District, China A2MAC1 Full timePosition Value1.Understand latest and cost-efficient engineering solution through technical benchmark2.Learn the engineering excellent practices from high-performance vehicle products across the world3.Co-work with OEM or Tiers to attend in new product development phase4.Communicate with global technical or costing experts5.Utilize technical insights...
-
Costing & Insights Engineer(EE)
2 months ago
Jiading District, China A2MAC1 Full timePosition Value1.Understand latest and cost-efficient engineering solution through technical benchmark2.Learn the engineering excellent practices from high-performance vehicle products across the world3.Co-work with OEM or Tiers to attend in new product development phase4.Communicate with global technical or costing experts5.Utilize technical insights...
-
Costing & Insight Engineer(Pwt)
2 months ago
Jiading District, China A2MAC1 Full timePosition Value1.Understand latest and cost-efficient engineering solution through technical benchmark2.Learn the engineering excellent practices from high-performance vehicle products across the world3.Co-work with OEM or Tiers to attend in new product development phase4.Communicate with global technical or costing experts5.Utilize technical insights...
-
Segment Development Manager
5 months ago
Xuhui District, China Avery Dennison Smartrac Full time公司描述 Avery Dennison Corporation (NYSE: AVY) is a global materials science and digital identification solutions company that provides a wide range of branding and information solutions that optimize labor and supply chain efficiency, reduce waste, advance sustainability, circularity and transparency, and better connect brands and consumers. Our...
-
Changning District, China Maquet (Shanghai) Medical Equipment Co., Full timeAbout the RoleWe are seeking a highly skilled Director of Quality and Regulatory Compliance for our East Asia region. This role will be responsible for providing regulatory and quality leadership for our operations in China, Hong Kong, Taiwan, Macau, and Mongolia.Key ResponsibilitiesWork closely with our East Asia QRC teams to ensure compliance with...
-
Yangpu District, China Continental Full timeCompany OverviewContinental, a leading global provider of automotive technologies, is seeking a highly motivated and organized Procurement Assistant to join its NPM Asia Team.
