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Clinical Trial Manager/Senior Clinical Trial Manager

1 day, 9 hours ago
United States
Full-time
Senior
Program 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 78

Description

  • Serve as the primary clinical point of contact for the client.
  • Lead planning, conduct, and operational oversight of clinical studies.
  • Develop study clinical documents, including plans, ICF templates, forms, manuals, and training materials.
  • Identify training needs for CRAs and third-party vendors and support investigator and study kick-off meetings.
  • Generate site lists, drive feasibility assessments, and assess enrollment risks.
  • Develop country recruitment and retention strategies.
  • 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 and use metrics/reporting to track study performance.
  • Manage eTMF implementation, CAPA development and closure, and GCP audit preparation.
  • Collaborate with PM, data management, QA, CRAs, and other functions on budgets, quality, resourcing, and data cleanliness.
  • Manage investigational product processes, including drug accountability and reconciliation.
  • Support site budget and investigator contract negotiations and vendor management when needed.
  • May assume project management responsibilities when no cross-functional PM is assigned.

Requirements

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

Benefits

  • Annual discretionary bonus.
  • Health insurance.
  • Retirement savings benefits.
  • Life insurance and disability benefits.
  • Parental leave.
  • Paid time off for sick leave and vacation.
  • Compensation range of $110,700 to $200,900 USD.

Interested in this position?

Apply directly on the company website

Apply Now

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