Clinical PM Director-北京-广州
公司部门: Clinical Development
1. In accordance with relevant laws and regulations and the company's SOP and GCP, responsible for the management of clinical projects, including the initiation, monitoring, audit and regular data collection of clinical trials, timely discovery of problems, put forward questions and solutions, and ensure the quality and progress of the project。
2. Responsible for timely communication and coordination with relevant departments within the company in the process of project promotion; ensure that the team plans and delivers high-quality clinical trials in a timely manner, and is responsible for responsible team performance according to key indicators.
3. According to the needs of clinical projects, communicate with CRO companies, main investigators, clinical medical experts, and review experts to solve or assist in solving problems in the process of clinical research.
4. Develop a training plan for the clinical project manager team to improve project management skills and ensure high-quality delivery of clinical trial results.
5. Builds up clinical project managers team and manages resource according to trial needs, maintains a positive and results orientated work environment. Drives team members to improve their efficiency and effectiveness at prioritizing work and improving performance.
6. Ensures operational processes, systems and standards are adopted and implemented consistently across trials，Contributes to Clinical Operations and clinical trial sourcing strategy development and takes a lead role in cross-function governance.
7. Implements and revises SOPs and monitors team compliance. Participates in formal staff performance review processes. Communicates with internal and external staff effectively with a professional and collaborative approach.
8. Escalates issues to InnoCare Senior Management team timely, demonstrates strong initiative in activities through the clinical trials and other company initiatives, proactively identifies potential issues and seeks improvement.
9. Takes initiative for issue resolution within and outside the Clinical Operations department. Coordinates the risk management process encompassing proactive risk identification, evaluation (probability and impact) and mitigation plans.
1、 At least 8 years of clinical study experience in pharmaceutical company or CRO, and more than 4 years of project management experience;
2、 Familiar with the overall process of clinical study from the approval of the study until the end of the study, and fully understanding the coordination of all departments in each stage of clinical study;
3、 Those with project experience in the field of autoimmune diseases and oncology will be preferred;
4、 With good ability to communicate, manage and coordinate;
5、 Proficiency in MS Office Suite, including Excel, Power Point, and Project.
6、 Proficient in English as working language, good at reading and written English