Toronto, Ontario – Associate Director, Clinical Operations

Reports to:      VP Clinical Operations

Position summary:

Reporting to the VP Clinical Operations the Associate Director, Clinical Operations is responsible for the execution of all aspects of clinical trials.  Associate Director, Clinical Operations will be responsible for the:

  • Operational aspects of clinical studies for the Canadian Facility.
  • Management of the operational expenses for the Canadian Facility.
  • Meet expectations of corporate goals, timelines, cost and quality performance.
  • The Associate Director will oversee the planning, development, implementation, execution, and management of assigned clinical trials, as well as participate in other areas requiring scientific/technical expertise.

Duties and responsibilities:

  • Management responsibilities for the Associate Director of Clinical Operations for the Canadian facility
  • Ensures clinical trial activities are carried out by adhering to the policies, study protocols, SOPs, GCP and ICH requirements and pertinent regulations
  • Directs and supervises all Clinical Leads and assigned staff members
  • Responsible for providing support and guidance to the various clinic teams and to coordinate all operational activities of the clinic
  • Plans, organizes, manages and monitors the clinic activities/operations in order to achieve the expected results. Ensures that high-quality customer service is offered by all clinic employees
  • Assess performance of direct reports and other team members and establish goals and development plans with the clinic staff
  • Write SOPs, policies and rules to conduct phase 1 and bioequivalence clinical studies
  • Participates in strategic decisions and partnering activities to increase productivity, reduce costs, and ensure that corporate clinical goals are met on time and on budget
  • Maintains current professional knowledge base of clinical research methodologies and regulatory requirements
  • Interacts with Study Monitors, investigators, regulators, vendors, and others external to the Company
  • Serves as a key interface with Project Management with regard to budget, resources, priorities, strategy, and time lines.
  • Participates on Safety Committee, Protocol Review Committee, Inter-departmental meetings
  • Actively analyze and develop action plans to address issues brought up by QA, Study Monitors, sponsors and regulatory agencies
  • Performs other tasks and projects as assigned

Qualifications:

  • Nine or more years’ experience in clinical trials, five years in a management role and at least 4 years of relevant experience in a Clinical Research Organization
  • Significant experience managing Phase I-IIB, Bioavailability and Bioequivalence studies
  • Degree in Health Sciences or related discipline (MD or RN preferred)
  • CCRP certification
  • Computer literacy and excellent communication skills

Please send your resume to resumes@biopharmaservices.com