上海招聘

Responsibilities:

Basic Function:
Leads one or more cross functional study teams; Accountable for effective and efficient delivery of PD studies through all phases (start-up, conduct and close down) in accordance with appropriate quality standards including ICH/GCP
Primary Responsibilities include:
· Provides direction and leadership to one or more study teams to ensure delivery of all cross functional activities to meet study plans outlined by the clinical development plan
Builds effective high performing teams with clear roles and responsibilities for members
Chairs team meetings
Primary contact for key stakeholders eg OPL
Represents the study team at Clinical Team (ad hoc)
Ensures study team receives study specific and therapeutic training
· Creates and manages study timelines, budget, resource, risk and quality plans
Drive setting of study team goals and milestones and monitors progress
Establishes and maintains accurate study level timeline and resourcing plans and works with Functional Management to have correct resources in place
Leads development of protocol level feasibility and finalises country selection with OPL input
Ensures all the relevant functional groups provide input to develop and finalize core study documents including protocol, informed consent, CRF and SSPM (study-specific procedures manual).
Oversees the development and active management of the study patient recruitment strategies.
Oversees the drug supply requirements and availability across studies in liaison with the Global Trial Coordinator.
Finalize study budget based upon raw budget estimate from OPL, input from Global Study Manager and in alignment with DBA, Lifecycle Team/Clinical Team and SMT assumptions.
Management of study budgets, with appropriate input from the Global Study Manager to ensure efficient expenditure and minimal variance between actual and planned spend. Accountable for accuracy of forecasting at RFP rounds and making adjustments as necessary.
Ensures CTMS is updated and accurate
Ensure clinical data are reviewed in accordance with Study Data Quality plans
Oversees the safety reporting activities
· Provides direction and oversight of outsourced activities to ensure CRO and vendor delivery against contracted scope of work
Leads the identification and selection of vendors and ensures cross functional input into the scope of work
Inputs into the contract and budget negotiation led by Business Manager
Maintains oversight of performance, issues and their resolution to ensure studies are delivered in line with the agreed scope of work
· Identifies and contributes to areas of best practice and process improvements
Cross study review of quality, productivity and efficiency
Incorporates learning, recommendations from study debriefs and best practices
Contributes to functional excellence activities
Leads Study Debriefs (as appropriate)
· Provides study specific mentoring to GSMs and GSAs
· Ensures study adherence to ICH/GCP and SOPs
· As part of a clearly defined development plan, can take responsibility for additional activities in support of project level planning and implementation (in agreement with the Operations Programme Leader and GSL's Functional Manager). The OPL retains overall accountability for the project.(see supplemental information)

Requirements:

·Relevant working experience:
Strong leaderships and motivational skills developed through leading successful global multi-functional matrix study teams through all stages of clinical studies
Demonstrated consistent achievement of team delivery against commitments and goals.
Experienced project manager, having led the development and implementation of risk management plans, managed complex study budgets and resourcing plans.
Proven experience of all aspects of clinical studies including vendor/CRO management, leading/working as part of a HQ development team and coordinating study level activities to deliver data for filing or publication purposes.
Experience of influencing and negotiating at all levels to achieve team delivery.
Self-motivated and achievement driven.
Excellent written and verbal communications skills
·Education: BSc.
·Requirements on specific subject(s): BSc Life sciences degree or nursing equivalent.
·Language: Chinese and English (proficiency level)
·Computer skill: word, excel, PowerPoint
·Other skills and/or competence:
Project management
Decision Making
Collaboration and Teamwork
Influencing
Cost and Financial Awareness
Facilitation

More Information related to This Position

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罗氏药品临床研发亚太中心

罗氏药品临床研发亚太中心位于上海张江高科技园区，是罗氏在中国乃至亚太地区（不包括日本在内）第一个全功能临床药品开发中心，是罗氏药品开发部在全球的第五个研发地区。其前身为2007年10月成立的罗氏药品开发中国中心。

罗氏于2007年在中国率先设立全球药品开发中心，成为在华完成且体现药物研究、药品开发、生产制造和市场销售环节等整体价值链布局的跨国制药企业。此举不仅将加快新药在华的上市时间，使国内广大患者有望更早地受益于创新药物，而且将让更多的中国研究机构、学者、临床医生更早、更主动地参与到全球创新药物的开发过程。

罗氏药品开发中国中心从事药品开发工作，是把经过实验室筛选的分子转变成药物的关键一环，它通过国际多中心临床研究，鉴定药物的安全性和有效性，是驱动药物价值链的引擎。罗氏药品开发中国中心于2009年9月升级为罗氏药品临床研发亚太中心，负责罗氏在亚太地区的药品开发，令更多中国乃至亚太地区的患者尽早受益。