- 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 (e.g. description of services and transfer of obligations)
- Provide input into and hold accountability for the development of essential study level documents (i.e. Clinical Study Protocol (CSP) through to Clinical Study Report (CSR)) in accordance with relevant AZ SOPs
- Ensure all external service providers (i.e. 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 (e.g. 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 (e.g. 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 (e.g. 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 (e.g. 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 (e.g. 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 manager
- 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
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AstraZeneca Jing'An, 中国 全职Typical Accountabilities: In partnership with AZ enablement team, other AZ clinical experts and external service providers, the GSAM provides oversight to ensure study delivery. · - Leads/contributes to the preparation of delegated study documents (e.g. Informed Consent Form, Mas ...
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AstraZeneca Jing'An, 中国 全职Responsible for providing technical leadership as compound or indication lead within a cross-functional team to design, execute, analyse and interpret clinical studies. Ensures projects (including multiple studies) adhere to Good Clinical Practice and regulatory requirements. · T ...
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AstraZeneca Jing'An, 中国 全职Manager, Global Study Management is accountable for managing a global study management team and to ensure excellent study performance at study level. As line manager of a team, he/she is responsible for building a sustainable capability development framework and developing talent ...
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AstraZeneca Jing'An, 中国 全职Key Accountabilities · Driving the cross-functional team to make out and carry on the product development strategy as technical leader. · Identifying the unmet medical needs on the indications, providing qualified medical assessments to guide clinical development teamwork. · Pro ...
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AstraZeneca Jing'An, 中国 全职Responsible for providing technical leadership as compound or indication lead within a cross-functional team to design, execute, analyse and interpret clinical studies. Ensures projects (including multiple studies) adhere to Good Clinical Practice and regulatory requirements. · T ...
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AstraZeneca Jing'An, 中国 全职Obtain and maintain essential documentation in compliance with ICH-GCP, AZ Procedural Documents and local regulations both in the office and at site. · Actively participate in local Study Delivery Team meetings. · Contribute to the selection of potential investigators. · Train, s ...
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AstraZeneca Jing'An, 中国 全职JOB REQUIREMENTS: · Academic / Professional Qualification / Working Experience · Advanced SAS programming knowledge · 2 or 5+ years of working experience in Pharmaceutical industry · BSc or higher degree in Mathematical, Statistical, Computer Science or Life Science or equivalent ...
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Project Manager
1周前
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AstraZeneca Jing'An, 中国 全职Translational Medicine supports programs in all phases of development and focuses on making measurements on human samples to understand why, and identify which, patients benefit from particular treatments, what doses and schedules of treatments to use and the mechanisms underlyin ...
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Global Study Lead - Jing'An, 中国 - AstraZeneca
描述
RESPONSIBILITIES:
REQUIRMENTS:
【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