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Clinical Trial Operations Opportunities at Parexel

Clinical Trial Operations

Site Contract Leader

Job ID 57572BR Taipei, Taiwan
Job Description:
1. Act as Parexel's direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase2. Conduct, drive and manage country specific feasibility activities, which may include: Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments3. Configure, distribute, collect, review, and approve (Sr. iCSM) high quality country specific and/or site specific documents or essential regulatory documents (SRP) and any updated or amended regulatory documentation4. Customize, review, and negotiate as required country/site specific Informed Consent Forms (ICF), translations (in accordance with country/regulatory/client requirements), and any amendments5. Prepare and submit IRB/IEC application in accordance with country/regulatory/client requirements, following up until receipt of final approval6. Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy7. Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner as indicated per project requirements

Qualifications

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

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