Tigermed Group
Contractor PM-Tigermed Jyton-Spain (MJ000038)
Tigermed Group, Villa Espana Colonia, Texas, United States
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To implement project management of clinical trials effectively, and to ensure success of clinical trials.
Responsibilities
Make the project management plan: draft and implement a feasible project management plan according to SOPs, ICH GCP Guidelines, ISO14155 and other applicable regulations. Ensure the trial is managed under the project management plan. Make monitoring plan: draft and implement monitoring plan according to SOPs, ICH GCP Guidelines, ISO14155 and other applicable regulations. Ensure CRA is trained on 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 a positive relationship with sponsor and investigator. Minimum Qualifications
Academic / Major: Bachelor degree or above in Medical, Pharmacology or Biology related majors. Professional Skills: Adequate knowledge of medical device development, including local regulation and GCP. GCP certificate required. Working Experience: At least 5 years clinical trial experience, at least 3 years of independent project management experience, and experience of at least 3 medical device clinical trials. Fluent in both written and oral English. Good command of Microsoft Office. Other abilities such as communication skills, information‑gathering skills, strong project management skill, and strong time management skill. Seniority level
Not Applicable Employment type
Full-time Job function
Project Management Industries
Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Tigermed by 2x
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Make the project management plan: draft and implement a feasible project management plan according to SOPs, ICH GCP Guidelines, ISO14155 and other applicable regulations. Ensure the trial is managed under the project management plan. Make monitoring plan: draft and implement monitoring plan according to SOPs, ICH GCP Guidelines, ISO14155 and other applicable regulations. Ensure CRA is trained on 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 a positive relationship with sponsor and investigator. Minimum Qualifications
Academic / Major: Bachelor degree or above in Medical, Pharmacology or Biology related majors. Professional Skills: Adequate knowledge of medical device development, including local regulation and GCP. GCP certificate required. Working Experience: At least 5 years clinical trial experience, at least 3 years of independent project management experience, and experience of at least 3 medical device clinical trials. Fluent in both written and oral English. Good command of Microsoft Office. Other abilities such as communication skills, information‑gathering skills, strong project management skill, and strong time management skill. Seniority level
Not Applicable Employment type
Full-time Job function
Project Management Industries
Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Tigermed by 2x
#J-18808-Ljbffr