Context and Responsibilities

  • Working with the Senior Director of Clinical Operations and team to support the execution of the deliverables for the clinical studies whether interventional or observational
  • Monitoring of study deliverables
  • Performing protocol-related site management activities
  • Participating in study planning and set-up activities including vendor management, project management, and coordination of study and implementation plans
  • Supporting vendor relationships

 Activities

  • Contribute to the design, content, and preparation of clinical protocols, amendments, consent forms, study guides, monitoring plans, CRFs, and subject information sheets as well as quality system maintenance for clinical programs.
  • Assist in the identification of clinical trial investigators as required
  • Coordinate and take direct responsibility for activities associated with site start-up and management including review site-modified informed consent templates. May be required to be involved in the tracking of the budget and contract process
  • Monitor/Co-Monitor study sites
  • Contribute to or coordinate preparation and conduct of monitors workshops and investigator meetings
  • Work with the Director of Clinical Operations and assigned CRO to develop recruitment strategies
  • Provide input for screening and enrolment progress
  • Coordinate study-level investigational product arrangements and accountability and reconciliation
  • Participate in and support study teams and other cross-functional teams as necessary
  • Provide clinical site/CRO, vendor support by answering protocol-specific questions
  • Work with the Director of Clinical Operations, the Head of Clinical Research and the CRO to resolve patient eligibility questions and protocol deviations
  • Work with the CRO, the central lab and the Analytical team to coordinate shipment and analysis of clinical biological samples
  • Support and monitor CRO and third party vendor activities, including relationships and training, and the development of vendor specifications and scopes of work
  • Using relevant reports, identify progress of CRF data collection and query resolution
  • Monitor progress of studies, Identify study-related trends/issues and work with the clinical Director of Clinical Operations and CRO to implement corrective actions when necessary
  • Support preparation and quality control of Clinical trial applications, clinical study reports, and regulatory submissions.
  • Maintain correct information at Clinicaltrials.gov

 Role Qualifications, Experience, Knowledge & Competencies

Basic Qualifications

  • Life Sciences Degree
  • Previous biopharmaceutical clinical operations experience  (experience obtained working on industry-sponsored or industry-partnered clinical trials at academic institutions, or working on clinical trials at a biotech, pharmaceutical or CRO company)

Preferred Qualifications

  • Broad experience in life sciences or medically related field, including general knowledge of  biopharmaceutical clinical research
  • Previous biopharmaceutical clinical operations experience  (experience obtained working on industry-sponsored or industry-partnered clinical trials at academic institutions, or working on clinical trials at a biotech, pharmaceutical or CRO company)
  • Ability to understand technical, scientific and medical information
  • Understanding of drug development process
  • Competent in clinical trial technologies (EDC, IVRS, WVRS, Vendor dashboards)
  • Advanced computer skills
  • Experience in interactions with vendors, e.g., CROs and contract labs
  • Experience with administration of site budgets and grants with supervision
  • Experience with development of prospective site-selection criteria
  • Experience with reviewing adequacy of site-proposed ICs for compliance with relevant regulations
  • Detailed knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements
  • Ability to write and present clearly using scientific and clinical terminology
  • Experience dealing with time demands, incomplete information and unexpected events
  • Good organisational and planning skills
  • Experience working effectively in a team/matrix environment
  • Able to show initiative and creative thinking for problem solving

 

If interested in the position please forward your CV to recruitment@gyroscopetx.com