南京招聘

1. In general provide internal support to Project Leader/Clinical Operations Leader/ Data Operations Leader as a project resource supporting internal systems and systems set-up but also executing day-to-day data analysis of the operational study status (planned versus current) and reporting activities.
2. Prepare draft project plan including all sub plans (Communication plan, Risk Management plan, MSP, WSOP listing, Quality plan, etc.) for team discussion before Kick-off meeting,
3. Develop and maintain Central Files Maintenance Plan (CFMP) in co-operation with Project Leader and project team. Support implementation according to the CFMP and oversee quality checks according to the plan.
4. Prepare project documents and status reports for Project Leader.
5. Prepare study recruitment plan in co-operation with SMO (Site Management Organization) and Clinical Operations Leader which outlines key recruitment challenges for the trial and corresponding strategies to meet the milestone. Monitor compliance to the plan and report status to Project Leader.
6. Responsible for assigned tool management including set up and maintenance of the recruitment planning tool (SPARC) in co-operation with SMO; Maintain investigator /supplier portal.
7. Initiate, set-up and maintain Management Systems on a regular basis (GXDB, CTMS, PMED, other systems as required )
8. Develop routine Client Report format with Functional Leads using standard reports where possible. May be involved with ad hoc client requests for reporting.
9. Arrange project related training for project team members and new team members under the direction of the Project Leader/ Clinical Operations Leader and Data Operations Leader and maintain project specific trainings overview and records, including study specific system training and access for PI, site staff, new site staff, study team and new study team members (e.g. IVRS, e-CRF)
10. Attend project specific training, as required
11. Attend project meetings as required per SOPs and Work Instructions
12. Oversee implementation of Quality Plan, perform Project Management related quality checks on the study according to Quality Plan and in close co-operation with Project Leader (e.g. Study Manual, CRF completion guidelines).
13. Support Project Leader in identifying, implementing, reviewing and up-dating project specific operational performance metrics.
14. Support Project Leader in appropriate selection of third party suppliers. Manage internal procurement process, ensuring that appropriate Scope of Work documents and Purchase Requisitions are in place
15. Coordinator for Vendors to answer queries, provide study updates, reports and trackers if required
16. Work with Project Leader and Project Analyst to develop “what if” scenarios to ensure pro-active decisions and solutions.
17. Document Lessons Learned and post in Lessons Learned database.
18. Conduct project close out in management systems at end of project (GXDB, CTMS, PMED, and other systems as required). Request export of project central file to sponsor and review the export to ensure, that it meets the required specifications
19. Ensure SAE reporting process and plan has been developed by the Medical Lead or relevant client contacts. Distribute PMED link for SAE and AE reporting procedure to the study team, if required
20. May communicate with the client on specific items as directed by the Project Leader.
21. Manage the project resourcing – resource requests.
22. Support projects for in-house audits.
23. Support Project Leader and Clinical Operations Leader in set up of a study specific payment procedure, where required. Ensure investigator information and payment details are entered in the CTMS, administer investigator payments; track payments, ensure timely processing and secure all approvals as needed.
24. Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics)


*Job Qualifications

Proven relevant experience in healthcare, clinical research, project management or contract research organization.

Education
Preferred a Bachelor’s degree or equivalent in a science related field, with an advanced degree desirable
or sufficient, relevant job experience
or another relevant education

Language Skills
Proficient in local language and profound working knowledge of the English language

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。