北京招聘

职位描述：
Overview
Clinical Project Manager or Director will be accountable for the implementation, management and reporting of assigned clinical trials. In this role, she/he will lead the execution of the clinical studies in conformance with Good Clinical Practices (GCP) and in accordance with the International Conference of Harmonization (ICH) Guidelines. Will be a key member of the clinical project team working closely with the Medical Leader and other key functions, and will be accountable for all aspects of assigned study execution including where applicable, CRO selection, study plan design, execution, study start-up, CRO and vendor management and performance, study budget and timelines. Develops all study plans in collaboration with the CRO. Manages all aspects of clinical operational plan.
Responsibilities
? Ensure successful completion of clinical studies that are on time and within budget. Accountable for ensuring all needed aspects of clinical operations are identified (drug, resources, contracts, budgets, etc) and planned in timely manner. Generate contingency plans where necessary, proactively identify potential issues/risks and mitigate.
? Manage and monitor performance of all CROs and vendors to ensure successful completion of program with regard to timelines and budget.
? Manage the budget, contract requirements, and performance metrics for the team to ensure that trials/development program plans are on target.
? Work with DM to develop data capture tools that reflect the requirements of the protocol. Review clinical data and metrics to identify trends.
? Develop mitigation plans as necessary.
? Review and approve clinical supply and dispensing design and drug labels.
? Liaise with CRO on Investigational Review Boards (IRBs) and Ethics Committees (ECs) requirements and questions.
? Review and contribute to key study documents including protocols, case report forms (CRFs) and Informed Consent templates.
Qualification
? Bachelor’s degree in Life Sciences, Pharmacy or Life Sciences. Advanced degree preferred.
? At least 5 years of experience working in industry and or with a CRO is required-managing clinical studies. The director must be able to work collaboratively with others both internally and externally. Oncology experience preferred
? Good working knowledge of GCP and ICH guidelines
? Title and compensation commensurate with qualifications and experience
? Proactive and organized with exceptional follow-up
? Anticipate/ identify problems and takes appropriate action to correct
? High degree of accuracy with attention to details
? Excellent team player 举报 分享

CStone Pharmaceuticals is an innovative, research-based, biopharmaceutical company committed to the development of a new generation of therapeutic drugs. Based in both Shanghai and Suzhou, the company's leadership team consists of seasoned executives from top pharmaceutical MNCs. In July 2016, CStone announced the completion of its Series A financing, raising a total of US$150 million (about 975 million RMB). Three prestigious investment companies in the industry, Oriza Seed Venture Capital (Oriza Seed), Boyu Capital, and WuXi Healthcare Ventures (WXHV), jointly invested in the round. With an overarching commitment to meeting the most pressing needs of Chinese patients, the company's pipeline covers five therapeutic areas, including oncology, cardiovascular diseases, rheumatoid arthritis, hematology and autoimmune diseases. With immuno-oncology as CStone's core therapeutic focus, the company strives to lead Chinese research to the global market through its world class R&D team, its innovative portfolio, and an open innovation strategy.
基石药业是一家创新的研发驱动型生物制药公司，致力于开发新一代的治疗性药物，创立于中国上海和苏州两地，公司的领导团队由来自国际***药企的管理层成员组成。 2016年7月宣布完成A轮融资，共募集到1.5亿美元（约9.75亿人民币）资金，由三家颇具声望的投资公司参与，分别是元禾原点创业投资管理有限公司、博裕资本及毓承资本。
目前，基石药业拥有肿瘤、心血管、风湿性关节炎、血液病及自身免疫病等五个治疗领域的产品线，旨在满足中国病患重大迫切的临床需求。在广受瞩目的肿瘤治疗领域，基石药业以其出色的肿瘤免疫药物为核心，凭借其世界级的研发团队，最前沿的药物研发项目，以及开放式创新的策略有望引领国内新药研发行业走向全球。