艾昆纬
Site Activation Specialist (SSU/RSU)
Site Activation Specialist (SSU/RSU)
发布于 大约 3 小时前普通员工/个人贡献者
Taipei , Taipei City, Taiwan
中级经验
全职员工
仅现场办公
本科
医疗、制药与临床研究
SOP
ICH
ICF
Regulatory Affairs
Clinical Research
AI 估算 · 55k–75k
Based on 3 years clinical research experience in Taiwan, median salary for this role is around 65k TWD/month with 13-month annua
职位详情
关于这个职位
作为Site Activation Specialist，您将负责临床试验中心的启动与维护工作，确保符合法规和SOP要求
您将作为研究中心、项目经理和内部团队的核心联络人，推动项目按时交付
适合有临床研究经验、擅长沟通与多任务管理的专业人士
最低要求
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.
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.
工作职责
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 SOPs, Work Instructions, 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, ICF, and Investigator Pack 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.
AI 洞察
优缺点分析
优点
- Work in a global CRO with exposure to diverse therapeutic areas and cutting-edge clinical trials.
- Develop deep expertise in clinical trial start-up processes, a critical niche in drug development.
- Opportunity to build strong network with investigative sites and sponsors.
- Stable industry with consistent demand for clinical research professionals.
- High pressure to meet tight project timelines and regulatory deadlines.
- Requires meticulous attention to detail
- errors can delay trial progress.
- May involve repetitive document handling and administrative tasks.
- This role is ideal for professionals with clinical research experience who enjoy coordinating complex processes, working with diverse teams, and ensuring regulatory compliance.
缺点 / 挑战
暂无明显挑战项
角色解读
- Advance to Site Activation Manager or Project Manager leading global studies.
- Specialize in regulatory affairs or clinical operations management.
- Move into clinical research leadership roles within CROs or pharmaceutical companies.
- Serve as the primary liaison between investigative sites, project managers, and internal teams to ensure smooth site activation.
- Prepare and review regulatory documents, track document approvals, and ensure compliance with GCP/ICH guidelines.
- Monitor site performance metrics and provide feedback to improve project timelines and quality.
- Coordinate with sponsors and local authorities to facilitate regulatory and ethics submissions.
- Strong knowledge of clinical trial regulations (GCP/ICH) and local regulatory requirements.
- Excellent communication and negotiation skills to manage multiple stakeholders.
- Organizational and project management skills to handle multiple sites and deadlines.
- Attention to detail for document review and quality control.
申请策略
- Tailor your cover letter to demonstrate your understanding of the site activation lifecycle and your ability to work independently.
- Research IQVIA’s recent clinical trials and express interest in contributing to their global impact.
- Emphasize your experience in site activation, regulatory document preparation, and familiarity with GCP/ICH guidelines.
- Highlight any leadership or mentoring experience (e.g., leading a small team or training junior staff).
- Showcase your ability to manage multiple projects and meet deadlines with specific examples.
- Include any experience with clinical trial management systems (CTMS) or electronic document management.
- Strengthen knowledge of local regulatory requirements in Taiwan and ICH E6(R2) guidelines.
- Improve project management skills (e.g., PMP certification could be an asset).
面试指南
- Use the STAR method (Situation, Task, Action, Result) to structure your answers, focusing on concrete examples.
- Demonstrate your knowledge of regulations by referencing specific guidelines (e.g., ICH E6) and how you ensured compliance.
- Highlight your ability to collaborate and manage relationships by mentioning cross-functional team experiences.
- Can you describe your experience with site activation and regulatory document preparation?
- How do you prioritize tasks when managing multiple sites with competing deadlines?
- Tell me about a time you identified a potential compliance issue and how you handled it.
- How do you ensure effective communication with investigative sites and internal teams?
- What is your understanding of GCP and ICH guidelines, and how have you applied them?
职位点评
74
综合评分
Global CRO role in clinical trial site activation, purposeful work with moderate salary and limited flexibility.
更适合这类人
This role is best for candidates who value meaningful work in healthcare and professional development, and are comfortable with on-site, potentially deadline-driven environment.
表现最好
使命价值
相对薄弱
工作生活
薪资福利70
成长发展80
工作生活60
使命价值85
薪资福利
70中等
The salary is competitive for Taiwan's clinical research market, with typical annual bonus. Benefits not explicitly stated in JD but IQVIA likely offers standard benefits.
薪资信号市场水准 (55K-75K/月)
成长发展
80较高
The role offers strong exposure to global clinical trial processes and potential growth to management positions. However, no specific training programs mentioned.
技术前沿主流现代技术
技术栈GCP、ICH、Clinical Systems、Regulatory Guidelines
业务类型profit_center
工作生活
60中等
On-site work in Taipei office; no mention of flexibility or overtime. Typical office hours expected but may require overtime to meet deadlines.
工作模式仅现场办公
办公地点市区核心地段
加班情况未提及（无法判断）
使命价值
85较高
Clinical research contributes to developing new treatments, offering high social impact. The role supports regulatory compliance ensuring patient safety.
行业发展稳定成熟行业
社会影响正向社会影响力较高
创新程度稳健跟随主流
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