J&J Family of Companies Senior Site Manager in Beijing, China
Supports the operational execution of clinical trials. Conducts, records and reports trials in accordance with protocol, standard operating procedures, good clinical practices and regulatory requirements. Executes complex clinical trials activities following established standard operating procedures, good clinical practices and regulatory requirements. Oversees patient screening and enrollment at assigned clinical study sites. Ensures discrepancies are quickly and efficiently resolved. Monitors the creation and maintenance of source documentation, case report forms, and data reports assuring accuracy. Submits documentation as requested or required in a timely fashion. Designs site training and materials to ensure compliance to the investigation plan. Partners with senior staff to ensure the pre-study, initiation, routine monitoring, and close down visits of study sites. Recognizes problems and recommends corrective and preventive action.
A minimum of a BA/BS degree is required. A degree in a health or science related field is preferred. A minimum of 1 year of clinical trial monitoring experience is preferred.
Good working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
Good IT skills in appropriate software and company systems. Willingness to travel with occasional overnight stay away from home.
Proficient in speaking and writing the country language and English. Good written and oral communication skills.
J&J (China) Investments Ltd A- Beijing Branch (7075)
Clinical Trial Administration