Sr. CTM / CTM

South San Francisco, CA 94080

Posted: 02/07/2020 Employment Type: Contract-to-Hire Industry: Clinical & Scientific Job Number: 17110

Job Description


Sr. CTM / CTM

South San Francisco, CA

 

Responsibilities (Six-month contract eligible for renewal)

 
  • Assess feasibility of enrollment across different neurodegeneration indications by providing assessment of timelines/rate of patient availability
  • Responsible for study strategy development, protocol, CRF development, and Clinical Study Report preparation
  • Responsible for recruitment strategy and execution within agreed timelines, resources and budget
  • Responsible for development and execution of natural history studies within agreed upon timelines, resources and budget
  • Ensure effective development, implementation and execution of clinical trials within agreed timelines, resources and budget
  • Responsible for identifying, selecting, and closing out appropriate investigational sites for clinical studies
  • Manage all components of clinical trials from protocol inception through CSR completion including site selection, designing CRFs, data management plans, monitoring plans and protocol specific procedures
  • Identify program risks and develop and implement mitigation strategies for assigned programs
  • Negotiate clinical outsourcing vendor agreements including CRO, Central lab, ECG and electronic data capture as well as manage vendors with respect to contracted scope of work and budget
  • Serve as liaison between clinical operations and other functional areas
  • Design electronic data capture forms to insure proper data collection for all clinical study data
  • Responsible for ICF development, review and amendments, reviews protocols and amendments as needed
  • Attends clinical and project team meetings including study execution meetings and applicable CRO/vendor meetings

Requirements
  • BS/MS degree (science based) is required in a scientific or healthcare discipline, experience in neurodegeneration clinical trials (Alzheimer, Parkinson’ s, ALS) or rare disease clinical trials preferred
  • 12+ years of clinical and drug development experience, to include 9+ years of clinical trial management experience, 5+ years clinical program management experience
  • Working knowledge of FDA regulations and ICH GCP guidelines is required
  • Proven ability to implement and manage a clinical program
  • Strong analytical and strategic agility skills
  • Highly effective team player with exceptional interpersonal skills
  • Willing to travel domestically and possible internationally

Meet Your Recruiter

Felicia Id-Deen

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