Global Study Manager (Pharmaceuticals) - Remote based in Canada

Alphanumeric is hiring a Global Study Manager (Pharmaceuticals) to work remotely in Canada for one of the biggest Pharmaceutical companies in the world, based in Mississauga, Ontario.

Please be aware that we can only hire people already based in Canada with fully legal and valid documentation to work in Canada.

Preference for candidates based in Ontario due to the proximity to the Mississauga HQ, as some occasional on-site presence might be required

Conditions:

• Salary: 63 CA$/hour
• Employment: 9 months with high possibility to extend further
• Working Hours: Monday to Friday – 9am to 5pm EST (Standard Business Hours)
• Type of Work: Remote (Preference for candidates near Mississauga, as occasional on-site presence may be required for project work)
• Location: 100 Milverton Drive, Mississauga, ON
• Start date: early April
• Mandatory to be based in Canada with valid documentation (PR or valid Work Permit + valid SIN)

Requirements:

• 2+ years as a Global Study Manager or similar role (global study associate, study delivery lead, etc)
• 5+ years of experience in the field
• Bachelor's degree: life sciences or related discipline
• Experience with clinical studies and a good understanding of complex clinical development and regulatory processes.
• Experience leading a cross-functional team and working with several stakeholders within the pharmaceutical business
• Experience in any stages/phases of the global study processes
• Experience or some level of related exposure to oncology, respiratory, or immunology.

Main tasks and responsibilities:

• Global Study Manager (GSM) will be the Working Group (WG) Lead for Clinical Operations with accountability for the operational delivery of clinical study/studies to time, quality, and budget, company standards and scientific requirements, supporting decision-making at pace and leading study team to achieve overall study deliverables
• As Operational Working Group Lead, the GSM is accountable for the following deliverables (to be adjusted accordingly for the STOM FSO model):
  • Study Initiation Meeting; Clinical Study Activity Plan; Study Delivery Plan; TMF Quality Strategy Document; DCT Set Up; Study Demographic and Diversity Plan; Vendors Oversight Plan; Results Dissemination Plan; Investigator/CRA Meeting Set Up & associated training; Expected Document List; Recruitment Tracking; Budget tracking eTMF filing and Vendor Set Up and Management; Patient Engagement Activities; CSDD KOM & template; Safety Management plan; Protocol Deviation Management Plan; eTMF & vendor set-up; Pharmacy Manual
• Supports assessment and selection of FSO vendors
• Accountable for holistic oversight of FSO vendors according to the FSO handbook
• Responsible for assessment and selection of other study vendors under GCSD responsibility in consultation with GSL
• Ensures compliance with ICH/GCP guidelines, all applicable laws and regulations, and GSK SOPs for assigned studies. understand study contribution to program/submission
• Balances risk/benefit to make decisions based on clear understanding of impact on the study and project
• Proactively and effectively identifies, oversees, and mitigates study risks
• Ensures appropriate stakeholder communication, including study status, expectations, risks and issues
• Accountable to operate within the study budget
• Effectively leads empowered matrix teams
• Implements innovative approaches to study delivery through external facing advances in technology and sciences and encourages others within matrix and line teams to seek innovative perspectives and develop solutions.
• Responsible for operational input into protocol and informed consent form development, and other key study documents.
• Leads and conducts investigator meetings and other study related meetings
• Leads quality efforts to ensure protocol compliance and continual inspection readiness for assigned studies
• Ensures data quality plans and end to end data cleaning is performed instream by the responsible line functions
• Ensures Clinical Study Report is delivered on time and supports GSK's adherence to local regulatory guidance
• Oversees the activities of the countries participating in the study
• Provides support and coaching (where appropriate) to the SM
• Ambassadors in increasing utilisation of AIML tools, driving automation of manual processes, finding efficiencies and more effective ways of working