Job Overview :
Accountable for execution and oversight of local operational clinical trial activities in a country for assigned protocols.
Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols.
Responsible for managing country deliverables, timelines and results for assigned protocols to meet country commitments.
Responsible for quality and compliance in assigned protocols in country. - Contributes to the development of local SOPs.
Oversees CTCs as applicable.
Coordinates and liaises with CRM, CTC, CRA, (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones.
Collaborates closely with Regional Operations to align country timelines for assigned protocols. Provides support and oversight to local vendors as applicable.
Oversight and coordination of local processes.
Education / Qualifications :
Bachelor Degree and above, major in Life Science or Health Care related (Pharmacy is preferred). At least 7 years clinical research experience.
Oncology trial experience is a plus.
Well-organized, strategically minded, and result-oriented
Good project planning, organizational skill, team work and working attitude
Open-minded, excellent communication and leadership skills
Good communication in both Mandarin and English
Familiar with Microsoft Office
At least 7 years clinical research experience. Oncology trial experience is a plus.
Solid track record of initiating, planning and delivery of projects and knowledge of project management practices.
Thorough knowledge of ICH GCP and regulatory