Global Clinical Trials Project Manager

Global Clinical Trials Project ManagerGreater Toronto Area
Introduction
We are currently hiring a Global Clinical Trials Project Manager for our client based in the Greater Toronto Area. The Global Clinical Trials Project Manager will lead the operational planning, delivery, oversight and budget management of company-sponsored evidence studies and/or EAPs within the assigned therapeutic area (TA). This person is responsible for leading a cross-functional study team and supervising the CRO study team as well as for providing the teams with direction and guidance to enable successful study and/or EAP delivery. The successful candidate will also lead the study and/or EAP team in accordance with the clinical outsourcing model (i.e. EMPOWER, early access principles), current clinical trial regulations (e.g. ICH GCP), Standard Operating Procedures (SOPs), company policies and standard processes and in line with the company’s values and behaviours. This is a hybrid role, that will require 3 days a week in office.

Responsibilities

• Partner with direct manager, ensuring provision of expertise and operational input into the programs (e.g. IMAP, ERT, MARCO, SDC, CSP)
• Collaborate with Dir EPM /Sr Dir EPM and provide adequate input to enable effective CRO selection
• Work with externally managed/outsourced partners for studies planning and delivery
• Serve as the reference point for communication and escalation of issues
• Mentor, coach and support the study team members.
• Lead a cross-functional study team in accordance with EMPOWER to ensure study progress as planned and driving achievement of breakthroughs.
• Be primary company point of contact for the CRO Project Manager to secure study delivery according to set criteria.
• Ensure the appropriate level of oversight of the CRO is maintained and documented throughout the study lifecycle in alignment with relevant to the company’s SOPs and guidelines (e.g. Sponsor Oversight Plan, Description of Services)
• Co-ordinate/lead timely contributions of the company;s core/extended members
• Collaborate with key partners cross-functionally, and/or external partners, to identify, handle and resolve issues affecting study delivery
• Review protocol drafts and input operational perspectives/content into document and authoring team discussions
• Provide input into and/or quality review and hold accountability for the development of crucial study level documents (e.g. ICF, study plans and guidelines), delegate responsibilities among the team as appropriate
• Ensure all required External Service Providers (e.g. CROs) are engaged at the study level (including execution of relevant vendors contracts) and are performing to contracted goals, timelines and budget, as well as adequate oversight is documented
• Responsible for study budget management through the study lifecycle and for providing budget progress updates to Dir EPM /Sr Dir EPM including any financial risks and mitigation plans (as part of the ongoing study change control process)
• Maintain/report accurate cost forecasts throughout study, lead study spend within available budget & agreed tolerances
• Lead/be responsible for financial processes (PO's, invoicing, cost reconciliation etc.), may delegate as appropriate
• Responsible for setup of the study cost tracker
• Monitor study risks throughout delivery and oversee team in the development/implementation of mitigations and contingencies
• Oversee study/EAP level performance against agreed upon plans, achievements and key performance metrics, EAP exit strategy
• Identify and report quality issues that have occurred within the study, proactively communicate findings and corrective action plans (CAPA) to relevant collaborators
• Supervise periodic TMF QC and responsible for review of relevant sections/documents in accordance with SOP/Wiki
• Specifically in the EAP space if assigned to, in addition to the above:
• Lead program planning, set up, implementation and delivery of EAP in collaboration with local/regional/global medical and market access teams
• Participate in operational governance activities related to agreed CRO strategic and operational governance principles
• Perform vendor oversight to ensure EAP delivery to time, cost and quality
• Collaborate with vendors to ensure the EAP operational aspects are effectively undertaken and that they have clear remits for delivery
• Manage resolution of program specific issues and partner concerns with internal and external team members

Requirements

• Bachelor’s degree required preferably in medical or biological science or equivalent by experience
• Extensive pharmaceutical industry/CRO experience within clinical study/research project delivery, drug development process and relevant guidelines, for example GCP/ICH, for a specific therapeutic and geographical area
• Project Management qualification or demonstration of project management skills including scope, budget, timeline, resource management and use of associated tools
• Ability to effectively work with Clinical Research Organisations/External Providers
• Ability to mentor, develop and educate staff
• Leadership promoting motivation and empowerment of others in order to accomplish individual, team and organisational objectives
• Ability to look for and champion more efficient and effective methods/processes of delivering evidence studies focusing on key performance metrics around reliability, efficiency, cost and quality
• Consistent record in interacting widely and effectively within the company across regions, functions and cultures
• Persuasive communicator in English with a proven track record to work collaboratively in a multi-cultural environment
• Desirable:
• Experience and knowledge within compliance management of Early Access Program
• Advanced degree in medical or biological sciences or field associated with clinical research
• Experience of incorporating digital health and patent centric strategies into clinical studies

What We Offer

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