Job description for clinical project manager at Shanghai Sailybio Biotechnology Co., Ltd
main duty:
1. Communicate with key stakeholders, including study sites, ethics committees, data safety monitoring boards (DSMBs), and regulatory agencies.
2. Manage project risks, formulate risk mitigation strategies, and promptly solve problems that arise in the project.
3. Ensure that all clinical research activities comply with applicable regulations, guidelines and company policies.
4. Prepare and submit regulatory documents, such as clinical research protocols, investigator handbooks, ethics committee applications and regulatory reports.
5. Monitor project progress and regularly report project status and key milestones to senior management.
6. Lead the project team, provide guidance and support, and ensure the professional development of team members.
7. Support the analysis and interpretation of clinical data and provide scientific basis for project decision-making.
8. Participate in the clinical trial design and development process, including preparation and revision of draft protocols.
Qualifications:
1. Biology-related majors, more than 3 years of clinical project management experience, including at least 3-5 years of clinical trial project management experience, and experience in successfully managing multiple stages of research projects.
2. Familiar with international clinical trial standards, GCP, FDA, EMA and other regulatory agency requirements.
3. Strong project management skills, including time management, budget management and team leadership skills.
4. Excellent written and oral communication skills, able to communicate effectively in multi-level and cross-functional teams, Chinese is a plus.
