• Ensuring management of trials are done in compliance with ICH, GCP, MSD global standards, local laws and regulations. To maintain quality standards, the CPM is involved in additional protocol specific training and might be supporting co-monitoring with a CRA. Providing country specific guidance and oversight to CRO's where needed.
• Ensuring clinical trials are effectively executed and completed within budget, timelines and meeting enrollment commitments as well as routine updating of CTMS and other clinical systems. Pro-active trial management to identify challenges, develop effective mitigation plans and to appropriately escalate and inform all relevant parties.
• Manage site pre-selection and validation process. Support local investigator meetings, ensure contracts and applicable reg documentation is obtained prior to study start. Facilitation of all aspects of IRB/ERC and Regulatory Agency submissions (including local IC). PPOC for all logistical and operational issues and facilitate general communication.
• Oversee drug and clinical supplies management to ensure sites have timely availability of required materials to avoid disruption of protocol deliverables and to oversee appropriate final disposition of IMP.
• Ensure clinical study site close-out in accordance with local regulations and ensure dissemination of clinical trial results to the participating study investigators. Oversee appropriate file archiving of all relevant study materials in accordance with local law and MSD guidelines.
• Medical qualifications, bachelor degree or above in Clinical Medicine, Pharmacology and Public Health, etc., strong emphasis in science
• 5 years clinical research experience. 3 years Previous CRA experience desirable and strong organizational skills required.
• Proficiency in computer skills
• Result oriented
• Teamwork spirit and cooperation skills
• Customer focus
• Good communication skill
• Proactive and self-motivated
Job: Proj Mgmnt-Clinical Research Job Title:Sr. Spclst, Project Management
Primary Location: APAC-CN-11-Chaoyang
Employee Status: Regular
Number of Openings: 1
Company Trade Name:MSD
Job Segment: Clinic, Medical, Project Manager, Law, Manager, Healthcare, Technology, Legal, Management