岗位职责：

iCSM = initiation Clinical Site Manager

SSU = Site Start Up

主要负责临床试验前项目启动的相关工作，准备伦理和机构的相关文件。

有CRA, SSU或者CRC工作经验。

至少1年CRA或者SSU工作经验。

或2年CRC工作经验。

任职要求：

• Job Description
• Conduct country specific feasibility and/or site pre-qualification
• Review and validate site identification list
• Collect and negotiate Confidentially Agreements (CDA) as required
• Organize translations per country/regulatory/client requirements
• Review and approve country specific and/or site specific documents or essential regulatory documents (SRP)
• Customize, review, configure, and negotiate as required country/site specific Informed Consent Forms (ICF) and their amendments
• Prepare and submit IRB/IEC application and follow up until final approval received (initial submission and amendments)
• Prepare and negotiate as required initial and/or amended CSA at a site level
• Resolve CSA changes requested by the site and approve any change in CSA language with support from Site Contract Leader (SCL) as required
• Collect internal CSA signatures
• Complete routine departmental administrative tasks in an accurate and timely manner (e.g. timesheets, metrics, etc.)
• Proactively keep manager informed about work progress and any issues (including conflicting priorities and free capacity)
• Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, PAREXEL SOPs, other PAREXEL training requirements, and study specific procedures and training
• Ensure excellent understanding of project scope, milestones, budgets, and time codes and strive for high quality, timely, and efficient delivery
• Update all appropriate Clinical Trial Management systems (CTMS) as indicated per function on an ongoing basis and submit all relevant documents to central files per the Central File Maintenance Plan
• Escalate any site and study issues that require immediate action to the Functional Lead (FL)
• Proactively work with other project team members to meet project goals
• Show commitment and perform consistent high quality work

In addition;

• Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced, and objective manner
• Manage complex sites and protocols across multiple therapeutic areas with a high level of autonomy
• Provide input to country selection strategy
• Support less experienced staff on project assignments as appropriate
• Recognize out of scope activities and communicate to FL
• Anticipate impact of issues/delays/changes on study timelines and communicate to FL
• Participate in internal audits/client meetings with minimal supervision
• Proactively inform manager about work progress and any issues to avoid unforeseen situations and recommend solutions
• Require minimal supervision by Manager
• Act as functional/technical Subject Matter Expert (SME) as required
• Identify inconsistencies and inefficiencies in processes/systems/trainings and recommend solutions
• Participate in internal and external process improvement initiatives
• Job Qualifications
• Excellent presentation skills
• Client focused approach to work
• Ability to interact professionally with external customers
• Flexible attitude with respect to work assignments and new learning
• Advanced ability to manage multiple and varied tasks with enthusiasm
• Attention to detail
• Ability to work in a matrix and virtual team environment and to value the importance of teamwork
• Strong computer skills including but not limited to the knowledge of Clinical Trial Management Systems (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word
• Excellent interpersonal, verbal, and written communication skills
• Advanced problem solving skills
• Sense of urgency in completing assigned tasks
• Excellent time management in order to meet daily metrics, team objectives and department goals
• Proven ability to work across cultures
• Excellent ability to work independently but seek guidance when necessary
• Excellent ability to influence and negotiate resolutions and outcomes with sites and IRBs/IECs
• Willing and able to travel locally and internationally occasionally as required

Education

• Educated to degree level (biological science, pharmacy, or other health-related discipline preferred), nursing or other relevant qualification/experience

Language Skills

• Excellent written and oral English and fluent in relevant local language

Minimum Work Experience

• Substantial previous clinical trial start-up experience or equivalent experience in clinical research with strong understanding of clinical trials methodology and terminology

上班地址：来福士