职位详情

临床项目管理高级经理(PM)

面议

北京朝阳区 3-5年 本科
上海复星医药产业发展有限公司

医药企业 其他 规模不详

职位描述
Base on Beijing

RESPONSIBILITIES:
1. Participates in site feasibility and/or pre-trial site assessmentv******** providing recommendation from local area aboutsite/investigator selection in collaboration with the trial team
2. Acts as primary local company contact for assigne******** forspecific trials.
3. Attend******** in investigator meetings as needed.
4. Responsible for executing activities within site initiationan********-up, site mon******** site management an********/studyclose-out according to internal SOP******** an********.
5. Ensures site staff are traine******** the corresponding trainingrecords are complete an******** at any time point during all trialphases.
6. Contributes to site level recruitment strategy an******** planningan******** in partnership with other functional areas to achieveclinical research target.
7. Ensures site study supplies (such as Non-IP, lab k******** etc.) areadequate for trial conduct.
8. Ensures that clinical drug supplies are appropriately used,handle******** store******** returns are accurately inventorie********documented.
9. Arranges for the appropriate destruction of clinical supplies
10. Ensures site staff complete the data entry an******** queries withinexpecte********.
11. Ensures accuracy, validity an******** of data collecte******** trialsites
Ensures that all AE******** are reporte******** the require********timelines an******** as appropriate. For AE********, ensures that theyare consistent with all data collecte******** with the information inthe source documents.


EDUCATION AND EXPERIENCE REQUIREMENTS:
A minimum of a BA/BS degree is required. A degree in a health or sciencerelate******** is preferred.
A minimum of 3 years of clinical trialmonitoring experience ispreferred.
Specific therapeutic area experience may be require******** on theposition.
Strong working knowledge of ICH-GCP, company standar********proce******** local laws an********, assigne******** an******** protocolspecific procedures including monitoring guidelines.
Strong IT skills in appropriate software an******** systems. Willingnessto travel with occasional overnight stay away from home.
Proficient in speaking an******** the country language an********.Goo******** an******** communication skills.
职位要求
  • 专业要求: 临床医学,药学
  • 最低学历: 本科
  • 工作年限: 3-5年
工作地点
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