南京-临床试验启动专员Site Start-Up Specialist (MJ001396)

岗位职责：
1、Prepare site GCP/EC documents, reviewing for completeness and accuracy and submit toassigned sites
2、Review, prepare and negotiate site contracts and budgets with sites, if applicable.
3、Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
4、Ensure contracts are fully executed unless special situation, EC documents and approvals are granted, Reviews essential document packages for site activation and IP Release authorized, may also be involved in essential document collection from site.
5、Review and provide feedback to management on site performance metrics.
6、Review, establish and agree on project planning and project timelines. Ensure overall project efficiency and adherence to project timelines.
7、Inform team members of completion of regulatory and contractual documents for individual sites.
7、May translate or review or verify completed translations of critical documents.
8、May support in feasibility and/or site identification activities.
9、May review or work with team members in preparation of regulatory submissions per work instructions, including site OHGRA filing docs, PFDA filing, etc.…
任职要求：
1、Bachelor’s Degree in life sciences or a related field and at least 1 year’ s clinical research or other relevant experience.
2、Proficiency in both written and spoken English.
3、Good interpersonal communication and organizational skills.
4、Good negotiating and communication skills with ability to challenge, if applicable.
5、Effective communication, organizational, and interpersonal skills.
6、Ability to work independently and to effectively prioritize tasks. Ability to manage projects with timeline pressure.
7、Knowledge and ability to apply GCP/ICH.
8、Knowledge of applicable SOPs and company’s Corporate Standards.
9、Ability to establish and maintain effective working relationships with coworkers, managers and clients.