職位描述
主要負責臨床項目啟動工作，職位名稱為Initiation Clinical Site Manager(臨床研究中心經理,啟動組)。
* 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 workIn 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/experienceLanguage 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
