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 

Toronto, Ontario – Facility Cleaner

Reports to: Facility Manager

Position Summary:

Cleaners are responsible for ensuring that the entire building is kept in a reasonably clean manner, at all times. They must follow their scheduled shifts and prioritize duties accordingly. Most importantly, they are to report all concerns immediately to a supervisor.

Duties and Responsibilities:

  • Washrooms are first priority at the beginning, during and before finishing every shift. If there is a study in progress then this is the starting point of the shift.
  • Ensure all work is done with consideration to health and safety with regards to yourself and all others.
  • Consistently inspect the entire building for cleanliness
  • Dispose garbage from all rooms throughout the building
  • Ensure all the furniture is kept clean
  • Sweep and mop floor surface of the entire building including staircases
  • Ensure all carpets are vacuumed regularly
  • All glass is to be kept clean
  • All doorknobs, walls and countertops are to be wiped
  • Clean lunch room daily as often as necessary
  • Keep outside the building grounds and parking lot clean
  • Seasonal ice/snow remove salt
  • Making of beds throughout Clinic Dormitories
  • Report all problems and concerns to your supervisor, if a concern needs immediate attention and your supervisor is not available please inform an available supervisor.

Qualifications:

  • Minimum High School or equivalent
  • Minimum 1-3 years prior work experience performing related or similar duties
  • Must be able to lift 50 lbs, bend, reach, climb stairs and stand for extended periods of time
  • Must be available to work mornings afternoons and weekends (variable shifts)
  • Hard-working individual
  • Good communication skills
  • Professional mannerism
  • Ability to prioritize assigned tasks
  • Able to multi-task

Please send your resume to  resumes@biopharmaservices.com