1. Job Purpose
To implement project management of clinical trials effectively, and to ensure success of clinical trials.
2. Responsibilities
* Make the project management plan: To draft and implement feasible project management plan according to SOPs, ICH GCP Guidelines, ISO14155 and other applicable regulations. Ensure the trial in managed under the project management plan.
* Make monitoring plan: To draft and implement monitoring plan according to SOPs, ICH GCP Guidelines, ISO14155 and other applicable regulations. Ensure CRA is trained of the monitoring plan and the site is monitored based on the monitoring plan.
* Manage site feasibility, site selection, initiation, monitoring, and close-out activities.
* Client Maintenance: Keep positive relationship with sponsor and investigator.
3. Minimum Qualifications
a) Academic / Major
* Bachelor degree or above in Medical, Pharmacology or Biology related majors.
b) Professional Skills
* Adequate knowledge of medical device development, including local regulation, GCP. GCP certificate required.
(c) Working Experience
* At least 5 years clinical trial experience, at least 3 years of independent project management experience. Experience of at least 3 medical device clinical trials.
(d) Fluent in both written and oral English.
(e) Good command of Microsoft offices.
(f) Other abilities such as Communication skills\Information-gathering skills. Strong project management skill; Strong time management skill.