1. Fully charge of quality monitoring and management of the clinical research projects shared;
2. Communicate with sponsor or CRA in a timely manner, conduct center screening, main researchers and participants in the research screening, to achieve the overall project budget in time;
3. Develop the overall project schedule, assist the CRA of each center to complete the schedule of each center, and complete the trial project as planned;
4. Complete the corresponding case report form, original medical record records, project management form and other documents in accordance with trial scheme formulated; submit central ethics data to team leader unit and get central ethics approval;
5. In charge of budget and purchase of trial materials, including printing, distribution, and transportation of case report forms, informed consent forms and other materials;
6. Review the clinical study contract of each center, and guide CRA to complete the negotiation and signing of study contract with each center;
7. In charge of providing guidance of relevant job in project to CRA.
1. Bachelor degree or above, medicine and other related majors;
2. At least 3 years experience in clinical monitoring, at least 1 year PM experience;
3. Have good abilities to communicate and coordinate; be able to accept business trips.
1. Complete clinical trial data review and statistical analysis;
2. Fully complete clinical trials statistics with high quality on time according to the requirements for statistical analysis;
3. Analyze the safety and efficacy of clinical trial data to generate statistical forms;
4. Conduct necessary exploratory analysis and other analysis of clinical trial data;
5. Conduct comprehensive safety and effectiveness analysis of the entire clinical project;
6. According to the requirements of the drug regulatory authority, prepare eCTD documentation for the new drug application, and support to answer project questions;
7. Formulation of SOP (and work guideline) in the business;
8. Perfect the working process, improving work efficiency;
9. Develop application statistical analysis macro program modules.
1. Education: Bachelor degree or above in medicine and related majors, proficient in English;
2. Proficient in SAS;
3. At least two years experience in data management, those with experience in complete project data management are preferred;
4. Attitude is rigorous, good at thinking, have strong communication and expression abilities.
1. Summarize and interpret drug registration regulations and technical guidance, and provide compliance guidance and risk management for the drug R&D of company;
2. Participate in communicating and coordinating with official departments such as CDE and CFDI;
3. Organize and coordinate to conduct official consultation on internal R&D related issues;
4. Follow up company's ongoing project allocation and coordination, follow up the registration project progress, find and deal with the problems in the course of the registration project in time, to ensure the completion of registration;
5. Coordinate and deal with related issues in registration review.
1. Bachelor degree or above in medicine and pharmacy;
2. At least two years related experience in registration, those with experience in applying for drug IND approval successfully are preferred; with experience in official job are preferred;
3. Familiar with drug registration regulations and application process;
4. Have excellent abilities to communicate and coordinate and have innovative spirit;
5. .Be dedicated, aggressive, responsible and upright.
1. Build up and perfect training management and complete relevant training work;
2. In charge of survey of training demand, formulate annual & quarterly training plans and specific implementing plans, and reasonably control training costs;
3. Organize the implementation of training, follow up and record the training process, organize training assessment, evaluate training results, write training reports, and put forward suggestions for training improvement.
4. Develop, screen and introduce external training resources and manage them effectively.
5. Complete other tasks assigned by leader.
1. Education: Bachelor degree or above.
2. Proficient in office software such as Word, Excel, PPT, Photoshop, etc.
3. At least two years experience in training.
4. Have strong language competence, affinity, appeal, responsibility and teamwork spirit.
5. Be a quick thinker, have good abilities to organize, coordinate, communicate and abilities to solve and analyze problem, with good writing and language skills.
6. Be good at training planning, organization and management, and have strong training curriculum development and teaching capabilities.
1. Write clinical trial protocol;
2. In charge of clinical medical support in the course of clinical trial project, such as writing, reviewing and revising of informed consent forms and investigator’s brochure;
3. Write, review and revise the clinical application data such as clinical study report and clinical study review;
4. In accordance with the needs of clinical projects, communicate related clinical protocol design with experts in clinical medicine and review;
5. Conduct medical monitoring and regular centralized data monitoring, and question the problems found, and follow up probleming;
6. Participate in clinical protocol seminar and summing-up meetings, and provide relevant medical support;
7. Provide medical support for company's NDA and IND;
8. Provide medical support and medical training to clinical trial team, and answer medical questions raised by the team.
1. Master degree or above in clinical medicine and related majors;
2. Have CRO or medical affairs management experience in pharmaceutical enterprise, have independently designed and conducted clinical trial in various fields;
3. Have excellent abilities to communicate, coordinate, influence, lead, judge and make decision;
4. Have experience in departmental management, have good abilities to organize, coordinate and communicate, and have good team work spirit, being conscientious;
5. Proficient in both Chinese and English medical writing and document retrieval.
1. In accordance with company's R&D strategy, follow up the clinical progress in the relevant medicine field, collect and reorganize the literature of clinical studies in relevant field, provide clinical evaluation opinions for the development of new products or technologies, to formulate a clinical development plan;
2. In accordance with the results of pre-drug study and R&D of similar drugs at home and abroad, write clinical review, design clinical trial plan, content of case report form, informed consent, investigator's brochure and other relevant clinical study data; and discuss with relevant experts to determine a perfect clinical trial plan;
3. Select the clinical research center and CRO/SMO, suppliers of data management and statistical analysis, in charge of implementation and monitoring of clinical trials;
4. Based on the results of clinical trials, write clinical study reports, write and update clinical reviews, investigator’s brochure and other clinical study data;
5. Assist registration department to complete the writing and recognizing, translation and proofreading of the clinical data in IND/NDA;
6. Train associated personnel on the clinical research and development of new products and related clinical knowledge.
1. At least 3 years clinical or clinical trial-related experience, those with experience in oncology projects are preferred.
2. Proficiency in English listening and speaking, and be able to read English documents proficiently;
3. Have strong communication ability and good teamwork consciousness; be familiar with common literature databases and literature retrieval methods.
1. In charge of the planning, development, management and coordination of clinical projects of company;
2. Assist superiors to carry out the selection, agreement negotiation of research units; hold meetings at various phases of clinical trials; and prepare clinical trial samples, materials and random items;
3. In charge of the implementation and monitoring of clinical trials, tracking and coordinating, to ensure that researchers conduct trials in accordance with relevant requirements of protocols, GCPs, and SOPs, ensure that trials meet ethical requirements, trial data are scientific and reliable and collected in time, and ensure that the research center can complete the enrollment and statistics of cases according to schedule;
4. Know the clinical trial progress of each center, supervise the implementation of clinical protocols, timely and properly handle AE and SAE, solve problems in clinical trial and process clinical data;
5. Regularly conduct field examination to the research center in accordance with the monitoring plan, and complete monitoring report within the given time. At the same time, report the visiting details to the superior, so that the superior can know the situation of trial process at any time, and find out and correct the existing problems;
6. Assist superiors in completing the clinical trial evaluation in project approval phase, and keep a good relationship with clinical hospitals and related clinical staff.
1. Bachelor degree or above in clinical medicine, pharmacy or nursing and other related majors;
2. At least 1 years CRA work experience;
3. Familiar with drug clinical research manage criterion and related laws and regulations, those with GCP training certificate (SFDA) are preferred;
4. Have good coordination and communication abilities; be able to take business trips, being conscientious;
5. Have good team work spirit.
1. Trial Management: assist researchers in coordinating application ethics, signing research agreements, etc.;
2. Subject management: assist researchers in screening, enrolling and follow-up visiting subjects;
3. Files Management: assist in completing the collection, filing and management of research data;
4. Data Management: Complete the input of clinical trial data of the operating system.
1. College degree or above in clinical medicine, pharmacy or nursing and other related majors;
2. Those with at least 1 year experience in clinical trial are preferred;
3. Have good communication ability, strong learning ability and good service consciousness.
4. Have strong independent working ability and teamwork spirit, being conscientious.
5. Familiarity with office software, compliance with relevant GCP regulations and company systems.
Capability and Competence: Divisional management, market management, operation of business division, team building, leadership, decision-making ability
1. Formulate business system development planning according to company's overall development strategy, determine business development directions and goals, and implement them;
2. Build up a perfect business processes, systems, standards and related management evaluations, and implement them; control business risks, continuously improve service levels, and ensure business efficiency;
3. According to the annual tasks assigned by company, organize the formulation of the annual work plan, implementation scheme and business policy of the business system;
4. Draw up commercial customer screening, evaluation, adjustment standards and management methods, and report to the company for approval before implementation;
5.In charge of the overall business management of Business Division, including channel planning, network construction, management of commercial clients, etc.;
6. In charge of file management and update of commercial clients, visiting VIP customers, and price system maintenance;
7. Organize to build up a perfect a business plan management system, do a good job of market forecasting, continuously improve the accuracy rate of business plans, and improve the efficiency of internal operations;
8. Complete other affairs assigned by leaders;
9. Have the business resource of CRO company and be able to lead the team to complete annual business tasks.
1. At least 5 years business management experience in large and medium-sized enterprises, and at least 3 years experience working in the CRO industry;
2. Have strong sense of judgments, be good at making decision, communicating, coordinating, organizing, planning and executing, and have rich team building experience and organizational development ability; be able to work hard and be active and enterprising;
3. Familiar with the pharmaceutical/CRO industry, have good resources of large-scale pharmaceutical distribution companies across the country, familiar with the current development of the industry and have unique insights;
4. Have strong ability to analyze and solve problems, have excellent resource integration capabilities and business promotion capabilities.
1. In charge of the market promotion of company's related business and contact;
2. Actively seek and manage target customers, facilitating project cooperation;
3. In charge of the feasibility research of customer potential projects;
4. Prepare and follow up the project plan and quotation;
5. Follow up and negotiate contracts with customers;
6. Follow up the change in requirements from costumers about company service, and provide up-to-date information;
7. Assist other departments of company to communicate with customers, making company's business run smoothly.
1. College degree or above, those with medical background or marketing major are preferred;
2. Those with related work experiences in sales, clinical trial or new drug R&D are preferred.