Clinical Trial Manager

cardiff by the sea, CA

Perm Salary

apply now




Overview

We are currently searching for a skilled professional to join a well-known client’s team as a Clinical Trial Managerin Los Angeles, California. The CTM role contribute to strategic planning to ensure optimized clinical development plans for assigned projects, provides direction in CRO and vendor selection and management, and also oversee clinical trial conduct and monitor work performed internally and externally. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity.

Responsibilities

  • Analyze therapeutic program to implement strategies and management tools to facilitate andimprove operational and financial management of therapeutic program
  • Analyzeand develop action plans to address issues with investigational sites, CROs, etc
  • Provide direction in CRO and vendor selection and management
  • Provide feasibility assessment for new clinical protocols
  • Manage Phase 1, 2, 3, and 4 clinical trials
  • Travel may be required up to 50%
  • Manage clinical studies and the process to identify and solve operational issues and drive delivery to plan through internal and external partners
  • Responsible for project management and execution, including the development, initiation, conduct and maintenance of realistic
  • Prepare, review and manage clinicalresearch budgets, timelines and performance metrics
  • Act as operational interface with external partners (e.g., alliance partners, CRO and vendors) for externally managed/outsourced activities
  • Review and provide technical expertise for vendor/partner contracts
  • Track items related to CDAs, contracts, budgets and completion status
  • Prepare study feasibility and study specifications
  • Maintain frequent contact and work effectively with site investigators and coordinators
  • Prioritize study monitoring needs
  • Review monitoring reports for accuracy, completeness and conformance with SOPs
  • Review and resolve discrepancies in clinical data with clinical sites
  • Resolve patient eligibility and protocol deviation issues

Experience

  • Strong communicationskills,proven negotiation skills and team player
  • Strong understanding of pharmaceutical development, clinical development, clinical research, study design, biostatistics, pharmacokinetics and medical terminology
  • Strong critical and logical thinking with ability to analyze problems, identify alternative solutions and implement recommendations for resolution
  • Understands and interprets data/information and its practical application
  • Self-motivated, flexible and creative leader, able to prioritize, multi-task, and work in a fast paced and demanding environment
  • Takes ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance, as necessary
  • Proficient in pertinent software and tools
  • Must be knowledgeable in industry trends for clinical operations
  • Master Protocol (e.g., basket, umbrella, tent trial designs) experience a plus

Qualifications

  • Minimum of Bachelor's degree, preferably in medical or biological sciences or discipline associated with clinical research from an accredited college or university. Advanced degree is preferred
  • 8 years of related pharmaceutical or bio-pharmaceutical industry experience, with at least 6 of those years directly in clinical operations

Google Ads

847-267-1176

Google Tags Manager Footer