Job responsibilities
1. Be responsible for the project management of the company's clinical trial, and formulate the budget and time limit of the clinical trial project, the number of personnel required and the project management plan;
2. In the whole process of clinical trial project implementation, manage the time limit and budget according to the above plan, maintain close communication with relevant functional departments or teams, master the project process and continuously report to the management;
3. Organize the project team to carry out clinical trials, including screening the clinical trial base, determining the main researchers, hosting the researcher meeting and research scheme discussion meeting, and formulating the supervision plan;
4. Organize regular project meetings to solve various problems in the process of project implementation;
5. Review all clinical research core documents, clinical research protocols, monitoring reports submitted by CRA, and communication letters with EC and Research Center;
6. Review and approve all travel applications related to clinical trial projects;
7. Guide the work of CRA, provide necessary project related training for CRA, and organize to participate in the inspection of the project by the management authority when necessary;
8. Internal and external communication.
Qualification
1. Education and major: Bachelor degree or above, major in clinical medicine and pharmacy.
2. Good English reading, writing, listening and speaking skills;
3. Working experience: more than 5 years of clinical trial supervision experience and more than 3 years of project management experience. Familiar with various regulations related to ICH-GCP and clinical trials in China. Be familiar with the process and work content of drug clinical trial, and the process and work content of clinical supervision;
4. Quality requirements: excellent leadership, communication skills and personality charm, honesty and trustworthiness, tolerance and cooperation, courage to challenge and good at communication.
Job responsibilities
1. Assist project manager to improve project related documents
2. Participate in the selection of test centers;
3. Assist the project manager to organize scheme discussion and summary meeting;
4. Be responsible for the project start-up of their own center;
5. Be responsible for the specific implementation and supervision of clinical trials in their own center, ensure that the project is carried out in accordance with national GCP requirements, test scheme and company standard operating procedures, and do a good job in the whole process of quality control;
6. Be responsible for sorting, improving and archiving all test documents and data of their own center,
7. Check and report the test progress and quality, medical record filling, use and recovery of test drugs, adverse drug reactions and other aspects, find problems, analyze problems, propose solutions and implement them;
8. Track and report adverse events and serious adverse events during the experimental study to protect the rights and interests of subjects;
9. Regularly summarize and submit audit reports or other relevant forms to ensure that the data are true, accurate and complete;
10. Check the original data and HIS system regularly;
11. Ensure smooth communication with researchers, institutional personnel and ethics personnel of each center and maintain good relations;
12. Participate in relevant training, meetings, examinations, etc. of the project in charge;
13. Maintain good communication and coordination with superior supervisors, internal supervisors, CRC, other project teams and other departments;
14. Active learning to improve professional knowledge and professional level;
15. Put forward constructive suggestions on project promotion and quality;
16. Cooperate with the audit department and make timely rectification according to the audit report;
17. Complete other related work assigned by PM manager.
Job requirements
1. Education and major: major in medicine and pharmacy, bachelor degree or above;
2. Working experience: more than 1 year of CRA working experience, excellent fresh graduates are also welcome;
3. Skills:
1) Familiar with drug registration management measures, GCP regulations and relevant regulations on clinical research;
2) Familiar with clinical monitoring process, able to carry out various monitoring and related work independently;
3) Good written and oral expression skills, coordination and plan implementation skills;
4. Quality requirements: honest and upright, calm, fair, modest, careful, team spirit, strong sense of responsibility, strong pressure resistance, and able to travel.
Wechat Qr Code
Headquarters address：Room 1510, Building A, Wanda Plaza, Building 2, Yard 6, Fengke Road, Fengtai District, Beijing
