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Clinical Trial Manager/Senior Clinical Trial Manager

1 hour, 47 minutes ago
United States
Full-time
Senior
Program 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 47

Description

  • Serve as the primary clinical point of contact for the client.
  • Collaborate with the project manager on monthly invoicing, variance management, and clinical budget oversight.
  • Develop clinical study documents, including clinical plans, informed consent templates, study 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.
  • Generate site lists, drive site feasibility, and assess enrollment risks based on feasibility analysis and site commitments.
  • Develop and finalize country-level recruitment and retention strategies.
  • Build effective working relationships with investigators and study teams to support feasibility, site start-up, enrollment, maintenance, and closeout.
  • Lead internal clinical team meetings and set expectations for CRAs and CTAs.
  • Address CRA and site questions and maintain an FAQ log as needed.
  • Oversee submissions and approvals to competent authorities and IRB/ethics committees, and support regulatory coordination.
  • Develop clinical monitoring strategies and use study metrics to track timelines, quality deliverables, and study conduct.
  • Manage eTMF implementation, CAPA development and closure, audit preparation, investigational product processes, data quality coordination, and site/vendor oversight.

Requirements

  • Bachelor’s degree or equivalent combination of education and experience in a science or health-related field; advanced degree preferred.
  • Minimum of 7 years of clinical research experience or demonstrated equivalent competencies, with significant clinical monitoring experience.
  • Experience with Microsoft Office products, including Outlook, Word, Excel, and PowerPoint.
  • Excellent communication and interpersonal skills for team-based collaboration.
  • Strong organizational skills, attention to detail, and a customer-service mindset.
  • Ability to travel domestically and internationally, including overnight stays.
  • Mastery of ICH-GCP, relevant SOPs, and regulatory guidance, with the ability to implement them.
  • Working knowledge of clinical management techniques and tools.
  • Direct experience working in a cross-functional environment.
  • Proven experience in functional management, delegation, planning, risk management, and change management.
  • Strong presentation, verbal, and written communication skills.
  • In-depth experience in pharmaceutical and/or device research.
  • Experience in independent negotiation and conflict management.
  • Advanced degree preferred.

Benefits

  • Discretionary annual bonus.
  • Health insurance.
  • Retirement savings benefits.
  • Life insurance and disability benefits.
  • Parental leave.
  • Paid time off for sick leave and vacation.
  • Compensation range of $100,700 to $200,900 USD.

Interested in this position?

Apply directly on the company website

Apply Now

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