临床项目经理(Clinical Project Management)
Refresh at 8 months ago
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Singapore
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Job responsibilities
Responsibilities:- Develop and manage project plans, including timelines, budgets, and resource allocation- Coordinate and oversee activities of cross-functional project teams, including investigators, Contract Research Organizations (CROs), and other external vendors- Ensure all clinical trials are conducted in accordance with relevant regulations, guidelines, and Standard Operating Procedures (SOPs)- Regularly communicate with internal and external stakeholders, providing project status updates and addressing any issues or concerns- Monitor and track project progress, identify risks and issues, and implement corrective actions as necessary- Prepare and maintain study documents, including study protocols, informed consent forms, and case report forms- Manage clinical trial budgets, including tracking and reporting expenses, and ensuring projects are completed within budget- Participate in the selection and oversight of external service providers, such as central laboratories and data management companies- Work with the study team to ensure research sites are adequately trained and equipped to conduct clinical trials- Support the preparation and submission of regulatory documents, such as Investigational New Drug (IND) applications and Institutional Review Board (IRB) approvals- Stay current with industry trends, regulations, and best practices in clinical research management.
Job Requirements
Qualifications:1. Bachelor's degree or above in medicine, pharmacy, biology, or related fields.
2. Minimum of 1 year of clinical project management or related experience, with preference given to those with clinical project management experience at a CRO company.
3. Familiar with relevant regulations and standards in clinical research, including GLP and GCP.
4. Excellent communication skills and teamwork spirit, able to effectively coordinate and manage project teams.
5. Strong problem-solving and decision-making abilities, able to handle various challenges and difficulties in the project.
6. Strong planning and organizational skills, able to work according to predetermined goals and timelines.
7. Strong learning and adaptability, able to continuously learn and update professional knowledge.
8. Strong English reading and writing skills, able to effectively communicate and collaborate with foreign teams and collaborators.
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