理聘网-职位详情页，Senior Clinical Data Manager

岗位职责 1.Actively drive, co-ordinate and follow-up on data management plans and activities to ensure high quality data in line with expected timelines. 2.Oversight of DM activities performed by vendors to ensure compliance with the agreed scope of work, study protocols, regulatory requirements, and standard operating procedures. 3.Provide data management expertise to clinical study teams. 4.Participate in reviewing data from clinical studies to ensure robust, complete, and accurate data, and contribute to and review data related reports. 5.Identify and manage risks, in close collaboration with statisticians and clinical operations, in assigned clinical studies. Participate in the development and implementation of process improvements and standard operating procedures. 任职要求 1.M.Sc. or higher degree in a life science or mathematical/statistical discipline. 2.At least 8 years of experience from data management hands-on work in clinical research in the pharmaceutical, biotech or medical device industry (sponsor company or CRO). 3.Vendor management and vendor oversight of DM activities in clinical studies. 4.Oversight of vendor SOPs and ensure that they are compliant with company SOPs. 5.Familiarity with CDISC data standards and FDA, EMA and ICH guidelines and regulations. 6.Understanding of the full drug development process, including various clinical trial phases. 7.Experience from pivotal studies and submissions is a major advantage. 8Able to understand scientific and medical discussions. 9.Experience from EDC, IWRS, ePRO, eCOA and eTMF systems. 10.Insight in Decentralized Clinical Trials (DCT) is an advantage. 11.Experience with SAS, R, Python or similar is advantageous. 12.Excellent problem-solving skills. 13.Comfortable with working towards set timelines, both independently and in a team. 14.Positive and solution-oriented personality. 15.Excellent communication and cooperation skills. 16.High level of flexibility and adaptability.