職位描述
崗位職責：
iCSM = initiation Clinical Site Manager
SSU = Site Start Up
主要負責臨床試驗前項目啟動的相關工作，準備倫理和機構的相關文件。
有CRA, SSU或者CRC工作經驗。
至少1年CRA或者SSU工作經驗。
或2年CRC工作經驗。
任職要求：
*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
