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Clinical Trial Manager

3 days, 8 hours ago
China
Full-time
Senior
Project Manager
Project and Program Management
Apply Now
Precision For Medicine

Precision For Medicine

Precision for Medicine is a specialized scientific services company that helps pharmaceutical and life sciences clients innovate, develop, and commercialize next-generation medical products. With a diverse team of experts, they offer comprehensive serv...

Pharmaceuticals
1K-5K
Founded 2012
$225M raised
View All Jobs 86

Description

  • Serve as the primary clinical point of contact for the client.
  • Lead planning, conduct, and oversight of the operational portion of clinical studies.
  • Develop study-related clinical documents, including clinical plans, informed consent templates, forms, manuals, CRF completion guidelines, trackers, and training materials.
  • Identify training needs for CRAs and third-party vendors and present study training at investigator and kick-off meetings.
  • Generate site lists, drive feasibility assessments, and evaluate risks to enrollment targets.
  • Develop country-level recruitment and retention strategies.
  • Build 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.
  • Support investigator meetings and review or approve investigational product release packages.
  • Oversee submissions and approvals to Competent Authorities and IRB/Ethics Committees with regulatory teams.
  • Develop clinical monitoring strategies and use metric reporting to track study progress and quality.
  • Implement and manage the eTMF and support CAPA development and closure.
  • Assist sites, internal staff, and CRAs with GCP audit preparation.
  • Collaborate with data management, PM, QA, and CRAs on data quality, compliance, resource issues, and corrective actions.
  • Manage investigational product processes, including accountability and reconciliation.
  • May negotiate site budgets and investigator contracts, manage clinical vendors, perform data review, and provide line management.

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 competency for the role.
  • Significant clinical monitoring experience is required.
  • Oncology trial experience is preferred.
  • Ability to work from Shanghai or Beijing.
  • Experience with clinical study oversight in accordance with protocol, SOPs, ICH-GCP, and regulatory requirements.
  • Experience supporting site feasibility, start-up, enrollment, monitoring, and closeout activities.
  • Experience working with cross-functional teams, including PM, CRAs, QA, regulatory, and data management.
  • Experience with clinical systems and reporting tools such as CTMS and eTMF is preferred.

Benefits

  • Equal Opportunity Employer status with employment decisions made without regard to protected characteristics.
  • Reasonable accommodation available for applicants with disabilities during the application process.
  • Privacy policy and California applicant privacy notice provided for applicant data handling.

Interested in this position?

Apply directly on the company website

Apply Now

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