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Clinical Trial Manager

2 months, 1 week ago
China
Full-time
Senior
Project Manager
Project and Program Management
Apply Now
Precision Medicine Group

Precision Medicine Group

Precision Medicine Group specializes in precision medicine, utilizing targeted expertise and data insights to accelerate drug development and enhance the commercialization of next-generation medical products for the pharmaceutical and life sciences ind...

Pharmaceuticals
251-1K
Founded 2012
View All Jobs 48

Description

  • Serve as the primary clinical point of contact for the client.
  • Lead planning, conduct, and oversight of the operational aspects of clinical studies.
  • Develop clinical study documents such as clinical plans, informed consent templates, study forms, manuals, trackers, and training materials.
  • Identify training needs for CRAs and third-party vendors and present study materials at investigator and kickoff meetings.
  • Drive site feasibility, generate site lists, and assess enrollment risks and recruitment/retention strategy.
  • Build and maintain effective relationships with investigators and study teams to support site start-up, enrollment, maintenance, and closeout.
  • Lead internal clinical team meetings and set expectations for CRAs and CTAs.
  • Oversee submissions and approvals to Competent Authorities and IRB/Ethics Committees.
  • Develop monitoring strategies, track study metrics, and escalate issues related to timelines, quality, or compliance.
  • Manage eTMF implementation, CAPA development and closure, IP accountability, and data quality coordination.

Requirements

  • Bachelor’s degree or equivalent combination of education and experience in a science or health-related field; advanced degree preferred.
  • 5-8 years of clinical research experience or demonstrated equivalent competencies.
  • Significant clinical monitoring experience.
  • Oncology trial experience preferred.
  • Ability to ensure studies are conducted in accordance with protocol, SOPs, ICH-GCP, and applicable regulatory requirements.
  • Experience supporting regulatory submissions, site start-up, and study oversight in a clinical trial environment.
  • Ability to collaborate across functions including project management, data management, QA, regulatory, CRAs, and vendors.
  • Experience with clinical trial systems and reporting tools such as CTMS and eTMF is preferred.
  • Experience with investigational product management, including drug accountability and reconciliation, is preferred.
  • Potential line management experience is preferred.

Interested in this position?

Apply directly on the company website

Apply Now

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