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Sponsor Clinical Trials Project Leader

Date: Jan 9, 2022

Location: North York, ON, CA, M9L 1T9

Company: Apotex

 

About Apotex Inc.

Apotex Inc. is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 8,000 people worldwide in manufacturing, R&D, and commercial operations.  Apotex Inc. exports to more than 100 countries and territories and operates in more than 45 countries, with a significant presence in Canada, the US, Mexico, and India. Through vertical integration, Apotex is comprised of multiple divisions and affiliates including Apotex Inc., focused on generics; Apobiologix, a division of Apotex Inc. focused on biosimilar development; Aveva, an affiliate of Apotex Inc. fully integrated global developer and manufacturer of complete transdermal solutions; Apotex Consumer Products, a division of Apotex Inc. focused on brand name products; and Global Active Pharmaceutical Ingredients (GAPI), a division of Apotex Inc. focused on the manufacturing of active pharmaceutical ingredients (API) for Apotex and third parties. For more information visit: www.apotex.com.

Job Summary

 

Coordinates and oversees aspects of clinical studies for the development of new generic products, including, but not limited to: feasibility assessments, Requests for Proposal, vendor selection recommendations, contract negotiations and ongoing project management.  Supports the Project Team in the conduct/monitoring of studies and demonstrates commitment to the team construct.  Provides support and input to the Global R&D (GR&D) process by implementing the strategy to be pursued relative to outsourcing decisions.  Responsible for ensuring compliance with the study protocol and the validity of data generated in clinical studies.  Assists in the development and review of departmental SOPs and DPs.

Job Responsibilities

 

  • Performs feasibility assessments by evaluating the cost/benefits associated with the study and/or clinical project development.
  • Develops protocols/protocol synopses for patient and clinical endpoint studies by utilizing knowledge and experience, liaising with regulatory bodies, Regulatory Affairs and Clinical R&D staff and reviewing relevant regulations and literature.
  • Participates in the vendor selection process through the completion of request for proposals (RFP) and the negotiation and management of external vendor contracts (including confidentiality agreements and statements of work).
  • Leads the set up and execution of complex, mulitcentre trials with time frames of 12 to 24 months applying general principles of Project Management. This includes, but is not limited to, working closely with the 3rd party Contract Research Organization (CRO) or 3rd party Packaging CRO to:
    • Assist in site identification and qualification
    • Lead document reviews with stakeholders for various plans (e.g. Data Management Plan, Statistical Analysis Plan, Risk Management Plan, etc.)
    • Ensure timely delivery of the Investigational Medicinal Products and appropriate retention quantities to the clinical sites
    • Assist in the timely delivery of clinical trial enrollment
    • Manage and mitigate issues at clinical trial sites, with escalation, when required
    • Manage the budget
    • Lead clinical data reviews with internal stakeholders and assist in the timely delivery of database locks
    • Ensure inspection readiness at the clinical sites
  • Develops, fosters and maintains strong relationships with external providers in the field through participation in the selection and management of outsourcing and provider contracts.
  • Acts as a specialized resource to team members around potential courses of action for complex issues.
  • Participates on the RFP evaluation committee in the review and selection of the best vendor for the applicable project.
  • Assists in the evaluation of external vendor performance for suitability of future outsourcing activities.
  • Promotes and maintains objectives of Departmental and Organizational mission through actions and communication initiatives.
  • Keeps self on “leading edge” of specialized field through ongoing professional development.
  • Stays current on changing regulatory and GCP trends, policies and practices as they pertain to the conduct of Bioavailability/Bioequivalence studies, both on a national and international level.
  • Develops, recommends and participates in the development or revision of internal policies, procedures and standards which impact organizational unit.
  • Conducts duties following established Standard Operating Procedures and in a manner consistent with the appropriate regulatory guidelines, GCP requirements and respecting safety in the workplace.
  • Performs all work in accordance with all established regulatory and compliance and safety requirements.
  • Works in a safe manner collaborating as a team member to achieve all outcomes.
  • Ensure personal adherence with all compliance programs including Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
  • Demonstrates Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
  • All other relevant duties as assigned.

Job Requirements

 

  • B.Sc. in Health Science or related discipline, or R.N. Accreditation from a recognized Clinical Research Association is a definite asset.
  • 3-5 years of relevant clinical trials design or management experience. 
  • A working knowledge of clinical trials or experience in managing large-scale projects is also required.

COVID-19 VACCINATION POLICY: In accordance with Apotex Inc. (“Apotex”) policy, as of November 15, 2021, all individuals entering a Canadian site (including but not limited to employees, visitors, contractors and agency workers) must be fully vaccinated against COVID-19 in accordance with the current government requirements.  Further, all employees must maintain all future booster vaccines as approved and recommended by Health Canada.  Accommodation from these requirements for reasons pursuant to the Ontario Human Rights Code, or any other applicable law (most commonly for medical and/or religious reasons) will be reviewed and considered by Apotex.

 

At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.

Apotex offers accommodation for applicants with disabilities as part of its recruitment process.  If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.