Clinical Trial Manager

1 hour, 40 minutes ago
Full-time
Senior
Project and Program Management
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

Description

  • Serve as the primary clinical point of contact for the client.
  • Lead planning, conduct, and operational oversight of clinical studies within the defined scope of work.
  • 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 support investigator meetings and study kick-off meetings.
  • Drive site feasibility, generate site lists, and assess risks to enrollment targets.
  • Develop country-level recruitment and retention strategies.
  • Build and maintain effective working 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 clinical monitoring strategies, manage metric reporting, and escalate issues to PMs and CRAs as needed.
  • Manage eTMF implementation and oversee CAPA development and timely closure.
  • Support GCP audits, investigational product processes, data quality, vendor management, and other project needs as assigned.

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, with significant clinical monitoring experience.
  • Oncology Phase I trial experience in Australia is preferred.
  • Experience with Microsoft Office products, including Outlook, Word, Excel, and PowerPoint.
  • Excellent communication and interpersonal skills for effective teamwork.
  • Strong organizational skills, attention to detail, and a customer-service mindset.
  • Ability to travel domestically and internationally, including overnight stays.
  • Experience with clinical research systems and reporting tools such as CTMS, DM query trends, and monitoring reports is preferred.
  • Experience managing clinical vendors, site budgets, investigator contracts, or line reports is preferred.

Interested in this position?

Apply directly on the company website

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