Site Manager (CRA)--北京 上海

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.)are adequate 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.

QUALIFICATIONS

A minimum of a BA/BS degree is required. A degree in a health orscience relate******** is preferred. A minimum of 2 years of clinicaltrial monitoring experience is preferred.
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.