南京招聘

Perform tasks at a country level associated with Site Activation (SA)
activities in accordance with applicable local and/or international
regulations, standard operating procedures (SOPs), project requirements and
contractual/budgetary guidelines. May also include maintenance activities.

Essential Functions
● Under general supervision, serve as Single Point of Contact (SPOC) in
assigned studies for investigative sites, Site Activation Manager (SAM),
Project Management team, and other departments as necessary. Ensure adherence
to standard operating procedures (SOPs), Work Instructions (WIs), quality of
designated deliverables and project timelines.
● Perform start up and site activation activities according to applicable
regulations, SOPs and work instructions. Distribute completed documents to
sites and internal project team members.
● Prepare site regulatory documents, reviewing for completeness and accuracy.
● Ensure accurate completion and maintenance of internal systems, databases
and tracking tools with project specific information.
● Review and provide feedback to management on site performance metrics.
● Review, establish and agree on project planning and project timelines.
Ensure monitoring measures are in place and implement contingency plan as
needed.
● Inform team members of completion of regulatory and contractual documents
for individual sites.
● Review, track and follow up the progress, the approval and execution of
documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator
Pack (IP) release documents, in line with project timelines.
● Provide local expertise to SAMs and project team during initial and on-going
project timeline planning.
● Perform quality control of documents provided by sites.
● May have direct contact with sponsors on specific initiatives.

Qualifications
● Bachelor's Degree Bachelor’s Degree in life sciences or a related field and
3 years’ clinical research or other relevant experience; or equivalent
combination of education, training and experience.
● 3 years clinical research experience, including 1 year experience in a
leadership capacity. Equivalent combination of education, training and
experience.
● In-depth knowledge of clinical systems, procedures, and corporate standards.
● Good negotiating and communication skills with ability to challenge, if
applicable.
● Effective communication, organizational, and interpersonal skills.
● Ability to work independently and to effectively prioritize tasks.
● Ability to manage multiple projects.
● Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
● Knowledge of applicable regulatory requirements, including local
regulations, , SOPs and company’s Corporate Standards.
● Understanding of regulated clinical trial environment and knowledge of drug
development process.
● Ability to establish and maintain effective working relationships with
coworkers, managers and clients.

IQVIA（纽交所代码：IQV）是全球专注生命科学领域的高阶分析、技术解决方案和临床研究服务供应商。IQVIA利用深入分析、前沿技术、大数据资源和广泛领域的专业知识，智能连接医疗生态的各个环节。IQVIA Connected Intelligence？快速敏锐地为客户提供强大的数据洞察，帮助客户加速创新医疗的临床开发和商业化进程，以更好的医疗成果惠及患者。IQVIA拥有约72,000名员工，足迹遍布100多个国家/地区。

IQVIA拥有多元化的加强型隐私技术和保障手段，能够在保护个人隐私的同时对信息进行管理和分析，帮助医疗利益相关方有效开展精准疗法，获得更佳的疗效。这些洞见和能力能够帮助生物科技、医疗器械、制药公司、医学研究者、政府机关、支付方以及其他医疗利益相关方，获得对疾病、人类行为和科技进步更深入的理解，共同朝着治愈各类疾病的方向迈进。