Associate Director of Clinical Development

Berwyn, PA 19312

Posted: 10/10/2019 Industry: Administrative Job Number: 6603

McGrath Systems is accepting applications for a  Direct Hire Associate Director of Clinical Development  in the Berwyn, PA area.  

Job Description:
  • Ensure conduct of clinical studies comply with the study protocol, applicable Standard Operating Procedures (SOPs), and ICH (International Council for Harmonization) requirements for GCP and other relevant regulations
  • Plan study budgets, develop timelines and manage clinical studies/projects to the approved budget and timelines
  • Oversee, lead, and/or prepare clinical study documents [e.g., protocol, informed consent form (ICF), case report forms (CRFs), clinical sections of the Instruction For Use (IFU) and clinical study report (CSR)]
  • Identification and selection of clinical study sites and management of investigator and key opinion leader (KOL) relationship
  • Provide input to evaluate and select vendors/contractors [e.g., Clinical Research organizations (CROs), central laboratories, contract monitors] in accordance to study requirements and company SOPs
  • Define the scope of work to be outsourced, supervise outsourced tasks, and manage vendor/contractor relationships
  • Plan, present and participate at Investigators Meetings
  • Assist with the reporting and data analysis of clinical results
  • Ensure clinical studies/projects are inspection ready as appropriate
  • Other Duties as needed/required and delegated by the supervisor

 

Job Requirements
  • BA/BS degree in life sciences or related discipline
  • 8+ years of relevant experience in clinical development organization managing clinical trials in the biotech/pharmaceutical industry 
  • Good understanding of the device/drug development process
  • Working knowledge of GCP/ICH guidelines and FDA/EMA regulations

For immediate consideration email resume to nevans@mcgathsystems.com or call 215-278-8746

McGrath Systems is an Equal Opportunity Employer and embraces diversity in the workplace.

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