Clinical Trials Program Manager

4 days ago


Karachi, Sindh, Pakistan beBee Careers Full time

The successful candidate will oversee and manage the Down syndrome and Huntington Disease clinical translational programs and clinical trials research. This position requires a comprehensive understanding of Institutional Review Board (IRB) procedures, as well as management skills with a high degree of initiative and independent judgment.

Key Responsibilities:
  • Manage all aspects of the clinical research protocol, including clinical and neuropsychological assessments; training and supervision of staff; participates in clinical visits; ensures that clinical databases are kept up to date.
  • Manage study related documents including new Institutional Review Board protocols and continuing reviews, Investigational New Drug applications, and other regulatory documents.
  • Interpret and apply GCP and IRB policies to support research compliance.
  • Coordinate training program for, and oversight of, clinical coordinators/staff and manage assessment of competency for lab members.
  • Establish standards for the delivery of research procedures; act as a role model by providing excellent service to internal and external contacts.
  • Develop, evaluate and standardize operating procedures (SOPs) and effectively troubleshoots and resolves issues.
Requirements:
  • 5+ years of related clinical trials experience strongly preferred
  • Minimum of 2-3 years of clinical research experience, including management of all stages of interventional drug trials from study start up though data lock and study close out.
  • Supervise day to day operations of all study staff. Responsible for training and supervision of new staff.
  • Liaising with laboratory personnel.


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