Clinical Operations Manager简历模板

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Peter Xiong

phone13800000000
emailzhangwei@example.com
cityShanghai
birth35 years old
genderMale
jobClinical Operations Manager
job_statusEmployed
intended_cityShanghai
max_salary25k - 35k
Education Experience
Fudan University
985211
Clinical Medicine
Master
2008 . 092011 . 06
  • Systematically studied professional knowledge of clinical medicine, covering multiple core courses such as basic medicine and clinical medicine, with excellent grades and ranking in the top 10% of the major.
  • Participated in multiple medical research projects, exercised scientific research thinking and practical ability, and published 2 academic papers.
Work Experience
Shanghai Fosun Pharmaceutical (Group) Co., Ltd.
Pharmaceutical Listed CompanyInnovative Drug R & D
Clinical Operations Department
Clinical Operations Manager
Clinical Trial ManagementProcess OptimizationSupplier Management
2018 . 012023 . 06
Shanghai
  • Overall responsible for the operations management of clinical trial projects, developed project plans and budgets, coordinated cross - departmental teams (medical, statistical, monitoring, etc.) to ensure the quality, quantity and timeliness of project completion.
  • Established and optimized clinical trial operation processes and standard operating procedures (SOPs), improving team work efficiency by more than 30%.
  • Managed clinical trial suppliers (CROs, central laboratories, etc.), evaluated supplier performance, and reduced project costs by 15%.
  • Handled emergencies and risks in clinical trials, such as adverse events of subjects and data quality problems, to ensure the smooth progress of the trial.
Shanghai Roche Pharmaceuticals Ltd.
Multinational Pharmaceutical CompanyInnovative Drug R & D
Clinical Research Department
Clinical Project Manager
Project ManagementEthical ApplicationData Quality Monitoring
2014 . 072017 . 12
Shanghai
  • Led the initiation, execution and closure of multiple clinical trial projects, with a cumulative management of more than 10 projects, involving multiple therapeutic areas such as oncology and cardiovascular.
  • Responsible for the design of clinical trial protocols and ethical applications, successfully approved 8 ethical approvals.
  • Monitored the data quality of clinical trials, ensured data integrity and accuracy through regular inspections and audits, and reduced the data query rate by 20%.
  • Organized important meetings such as clinical trial initiation meetings and investigator meetings, and trained more than 200 members of the research team.
Project Experience
Phase III Clinical Trial of a New Anti - Tumor Drug - Project Leader
2019 . 012022 . 12
Shanghai Fosun Pharmaceutical (Group) Co., Ltd.
  • As the project leader, led the team to carry out the Phase III clinical trial of a new anti - tumor drug.
  • Developed a detailed project plan, coordinated more than 30 research centers across the country, enrolled more than 500 subjects, and completed the enrollment target 2 months ahead of schedule.
  • Optimized the data management process, introduced the EDC system, and increased the timeliness of data entry from 70% to 95%.
  • Handled serious adverse events that occurred during the trial, closely cooperated with the medical team to ensure the safety of subjects and the compliance of the trial.
  • The final trial results met the preset endpoints, providing key data support for the new drug's market launch.
Clinical Trial of a Cardiovascular Disease - Operations Leader
2015 . 012017 . 12
Shanghai Roche Pharmaceuticals Ltd.
  • Participated in a cardiovascular disease clinical trial project, responsible for operations management.
  • Established a quality control system for clinical trials, regularly conducted data audits and inspections, with a data accuracy rate of over 99%.
  • Coordinated research centers and laboratories, optimized the sample transportation and testing process, and shortened the testing cycle by 20%.
  • Organized project summary meetings, wrote clinical trial summary reports, and provided a strong basis for product registration and application.
Personal Summary
  • Over 10 years of clinical operations management experience, proficient in the full process of clinical trials, with rich project management and team leadership experience.
  • Familiar with domestic and international clinical trial regulations and guidelines (such as ICH - GCP, NMPA), ensuring project compliance.
  • Good at cross - departmental communication and supplier management, with good problem - solving and risk - response capabilities.
  • Have innovative thinking, promote the optimization of clinical trial operation processes and digital transformation, and improve team efficiency and project quality.
Honor Awards
2022 Company Excellent Project Manager
Other Information
Application of Digital Tools in Clinical Trials:
  • Proficient in various digital tools for clinical trials (such as EDC systems, RTSM systems, etc.), with experience in system implementation and optimization.
  • Promoted the digital transformation of the company's clinical trials, introduced new tools to improve work efficiency and data quality.