Manager, Clinical Trial Management

This is a fully remote position, open to applicants in Poland.

📋 Description

• Oversee daily clinical trial management activities, assisting your team in achieving high-quality results.

• Facilitate Risk-Based Monitoring (RBM) strategy meetings and create study-specific site monitoring plans in accordance with study risk assessments.

• Ensure that monitoring strategies are integrated with technological capabilities.

• Manage Site Monitoring assignments within the client's systems.

• Deliver Site Monitoring training and aid in the development and distribution of site monitoring materials.

• Act as the primary reviewer for site monitoring visit reports.

• Evaluate systems and dashboards to monitor site compliance with monitoring protocols.

• Address site monitoring requirements throughout the study's progression.

• Provide site management support as necessary during site monitoring visits conducted by Site Monitors.

• Initiate and oversee Monitoring Oversight Visits.

• Collaborate with the RBQM Operations team to resolve ongoing centralized monitoring issues with sites.

• Conduct periodic evaluations of site monitoring and Risk-Based Monitoring compliance KPIs and KQIs.

⛳️ Requirements

• Bachelor's degree in medicine, science, or a related field, or an equivalent combination of education and experience.

• Proven capability to manage the clinical deliverables of a study effectively.

• At least 6 years of experience in the pharmaceutical or CRO sector.

• Minimum of 2 years of experience in Site Monitoring, Site Monitoring Management, Risk-Based Monitoring, or Monitoring Excellence roles.

• Strong knowledge of drug development and the execution of clinical trials.

• Familiarity with industry regulatory requirements, including 21 CFR Part 11 and ICH E6 (GCP).

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.