Senior Initiation Clinical Site Manager
Parexel
Taipei, Taiwan
6天前

Job Description

1. Act as PAREXEL's direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase

2. 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 amendments

3. 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 documentation

4. Customize, review, and negotiate as required country / site specific Informed Consent Forms (ICF), translations (in accordance with country / regulatory / client requirements), and any amendments

5. Prepare and submit IRB / IEC application in accordance with country / regulatory / client requirements, following up until receipt of final approval

6. Submit all pertinent documentation to the trial master file as per project plans / sponsor / company policy

7. Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner as indicated per project requirements

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
  • Why Work at PAREXEL

    There are pivotal moments in every career : Sharing new treatments. Improving processes. Delivering life-saving advances.

    The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path?

    A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

    That’s Parexel. We’re a diverse team of professionals focused on one goal : getting treatments into the hands of those who need them most.

    Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

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