南京招聘

职位描述：
As a Country Study Manager, you will be responsible for:
Throughout the Study Lifetime:
Has full accountability for all assigned studies at Regional/country level (Global and local studies) including adherence to quality, timelines and budget.
Leads local study teams, represents Country/Region Clinical Operation at the global SMT, and provides Global Teams with feedback from a local CCO perspective (Global Studies).
Leads the local study team, including cross functional group leaders, and ensures GLORA process is followed (Local Studies), if apply.
Coaches, and provides indirect line management support in partnership with the relevant line managers to Sponsor in-house study team members (i.e. Country Study Specialist (CSS) and Study Start Up Specialist (SSUS)) by setting clear goals and expectations, monitoring performance, providing overall motivation, support, feedback and follow up to ensure team performance is fully optimized.
Provides oversight, leadership and support to CRO staff (ie Clinical Research Associates (CRAs) and Clinical Trial Assistants (CTAs)) to ensure overall delivery at the country and site level (time, quality, cost) and interfaces regularly with local Sponsor Vendor Manager and CRO Management regarding feedback on CRO staff performance.
Collaborates in the preparation of local quality/compliance reviews, internal audits and regulatory inspections and ensures adequate and timely CAPA follow up.
Actively conducts risk management activities (assessment, measurement and mitigation) on an ongoing basis in order to ensure overall delivery at the country and site level (time, quality, cost).
Identifies areas of best practice and contributes to activities to improve and maintain the quality and effectiveness of processes and activities within the function.
As requested by local Head of Clinical Operations and/or Therapeutic Area Leaders (TALs) and/or Country Medical Director participates in overall TA support in area(s) of expertise eg future landscaping activities, i***estigator/site development activities etc
Study Preparation Phase:


Leads and participates in the preparation phase of the study (feasibility, site selection, initiation) ensuring all other roles that support these activities both within Clinical Operations and externally contribute appropriately.
Provides support and expertise for regulatory, ethical and administrative submissions.
Accountable for ensuring i***estigator site recruitment targets and timelines are realistic and adequate to ensure recruitment to overall country commitment and developing and actively managing study patient recruitment strategies.
Accountable for the development of the local CCO’s study budget, initial study resourcing forecasts and establishment of study level plans.
Accountable for ensuring that TMF (country and site level) documentation is Inspection Ready by ensuring there are regular quality checks on the completeness and robustness of study related documents.

Study Conduct Phase:
In accordance with the overall project plan, manages and maintains accurate country/study level plans (i.e. timelines, budget, resource, risk and quality plans) in appropriate Sponsor planning system. Highlights deviations in plans to relevant parties, develops and implements mitigation strategies as required.
Develops and maintains effective working relationships, including being the key point of contact where appropriate, with key internal and external stakeholders, including i***estigators, local medical team, global study team, other local departments, external vendors/CROs etc.
In conjunction with local Head of Clinical Operations, Therapeutic Area Leader (TAL) and/or Medical Manager (MM) or the Country Medical Director (CMD), ensures relationships with key i***estigator sites, alliance partners and/or collaborative groups are optimized to ensure efficient and smooth conduct of the study.
Study Close-Out:
Ensures all activities related to site/study close-out are managed according to global and local processes.
Manages either directly or indirectly knowledge sharing activities via debriefs or other focus group activities.
You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.


Qualification:
Education and relevant working experience: University degree or equivalent in a medical/science-related field and/or 5 years proven experience in Clinical Research/Development or related industry.
Skills, Experience and Competencies:
Leadership: developed through leading multi-functional matrix study teams through all stages of clinical studies
Project Management: including implementation of risk management plans and management of complex study budgets and resourcing plans
Communication: excellent written and verbal communication skills demonstrated by the ability to present clear messages from complex information/data to all levels in the organization
Personal Organization: demonstrated ability to prioritize and manage multiple tasks, self-motivated and achievement driven.
Good knowledge of ICH GCP, GPP, Sponsor SOPs/Guidelines and quality standards related to study management.
Clear and accurate communication in written and spoken English.
Strong computer skills.
Clinical development experience on the operational aspects of conducting clinical studies including:
vendor/CRO resource management
leading/working as part of a development team
implementing clinical development plans
risk management
coordinating study level activities to deliver data for filing or publication purposes including interaction with local Business Units
Demonstrated ability to interact with different professional levels of the research community
Experience of influencing and negotiating at all levels to achieve team delivery 举报 分享

精鼎医药（Parexel International）是全球领先的药物研究合同委托机构（CRO），总部位于美国生物医药圣地马萨诸塞州的波士顿附近，在世界各地拥有71个办事处，约17,600 名员工，为超过100个国家的客户提供服务。

精鼎医药成立于1982年，在三十多年的历程中，一直致力于发展成为全球生物制药和医疗器械行业首屈一指的新型医学疗法开发和商业化服务供应商，并且取得了卓越成果。目前，我们能够提供全世界CRO领域全面的新药临床阶段研发服务，服务内容包括新药开发策略的拟定与计划、国际临床试验规划执行及整合、临床试验的监测、临床试验数据处理、临床研究统计分析、临床试验总结及统计报告、临床试验稽核服务、临床试验供应和物流服务、临床电子数据采集、临床医学信息管理系统、新药查验登记事务和国际临床试验相关法规咨询等。

将我们的全球法规监管专业经验、I-IV期临床研究服务、整合的电子化临床技术能力和商业化服务结合在一起的一体化解决方案，可帮助我们的客户更加顺畅、经济和高效的推动整个研发历程。