Job Title: CTM/Clinical Trial Manager Type: Contract Compensation: $55 - $60 hourly Contractor Work Model: Hybrid Clinical Trial Manager Location: Hybrid, Metro Toronto (Burlington) - 50% per month onsite 12 months contract+ (through 2026) Pay: $55 to $60 per hour The Clinical Trial Manager (CTM) is accountable for the operational and scientific oversight, the set-up, execution and delivery of their assigned clinical trials at the regional/local level . CTMs contribute to delivery of BI’s pipeline through accurate planning and efficient execution of trials that bring speed & value to participating patients and sites. responsible R/OPU and is accountable for the overall success and delivery of theirassigned clinical trial/s according to defined milestones and key performanceindicators (e.g.

Medicine

Excellence KPIs -MedEx). They are responsible for steeringand directing clinical trial activities, including patient and site engagementactivities, direct communication and interaction with multiple internal and externalstakeholders (e.g. investigative sites) and trial team members at a regional/local andglobal level. The CTM is responsible for managing the planning, implementation, and tracking of theclinical trial process as well as risk mitigation .

The CTM serves as a proactivemember of the trial team, liaising closely with the Clinical Trial Leader (“CTL”) onall study-related issues. Ensure the trial is conducted in compliance with GCPICH,local/global regulations, applicable SOPs andaccording to the trial protocol by overseeing CRO andinternal team activities. Creation, management and review of the R/OPU trialbudget to ensure appropriate level of financialoversight and planning accuracy.

Appropriate trial-specific training of R/OPU internaland external partners is performed in line with TrialTraining Plan. Accurate planning and co-ordination of operationalfeasibility of trial timelines for their R/OPU

- Verifies and provides input into the country and sitelevel feasibility and OPU commitment (site and patientcommitment). Finalize and validate site selection usingavailable data sources and local insights/expertise, incollaboration with other functions (i.e. Development and implementation of country levelengagement plans, recruitment planning and riskmitigation. Reportspatient and site level feedback as strategic insight to contribute to improving trial design with a focus onpatient value Oversees outsourcing of vendor services in the R/OPUin accordance to operating models and governance.

Trial Preparation related performance indicators: Regular communicationmaintained with local trialteam, internal and externalpartners. Implementation andincorporation of patientcentric initiatives tooptimize trial delivery andbring value to patients.Engagement plans in place,including recruitment andcontingency planning. Maintains oversight during clinical trial conductincluding adherence to GCP and all global and localregulatory requirements; compliance with SOPs andcontinuous risk monitoring/mitigation.

Incollaboration with other functions, ensures budgetoversight, including support of regular clinicalquality monitoring, and safety reporting.



Monitor progress of patient recruitment endpoints andproactively update and action contingencies throughouttrial conduct. Establish and maintain relationships with externalexperts, investigational sites, Patient Organizationsand other stakeholders by coordinating and ensuringcross-functional collaboration amongst CD&O; andappropriate functions (i.e Medical Affairs, MarketAccess, PAR) on regional/ local level.

Active participation in the CD&O; community with aspecial focus on participating in the CTM network, toactively contribute to functional excellence.

Trial Conduct related performance indicators: Documented Local TrialOversight Meetings. Ensures timely cleaning and delivery of clinicaltrial data. Ensures timely submission of the CTR to RegulatoryAuthority/Ethics Committee and other externalstakeholders as required by local regulations Shares information on trial results withInvestigational sites and, if applicable, Patients(e.g. lay summaries).

Trial

Closeout and Reporting performance indicators ~ Timelines achieved as percommitments and MedExtargets for database lock. Build and maintain engagement with Investigators,other site staff and Patient Organizations (POs), incollaboration with other functions, to ensure trialspeed and effective start up, conduct and close out. Establish and maintain relationships with externalexperts, investigational sites, Patient Organizationsand other stakeholders by coordinating and ensuring cross-functional collaboration amongst CD&O; andappropriate functions (i.e Medical Affairs, MarketAccess, PAR) on regional/ local level.

Performance

Indicators ~ Embraces innovative approaches and technologies, aswell as creates and maintains a culture that drivesempowerment, smart risk taking and one common CD&Oidentity.; Performance indicators Evidence of effective teamwork& leadership, goaldelivery and efficientdelivery of operationalaspects aligned to the OneMedicine visions (includinggoals, risk, mitigation).Regulatory and / or Organisational Requirements* Ensures all tasks are carried out in accordance with respective applicable BI SOPs, BIBusiness Practices, HTGs and regulatory requirements. Ensures that all interactionsand engagements are carried out with the highest ethical and professional standardsand that all work is accomplished with quality, in accordance with BI Values and afocus on speed and patient value.

Functionally leads local/regional trial team to ensure integrity of trial conduct, assurance of patient safety, and that local/regional component of trial is planned, conducted and reported in line with regulatory requirements. Requires orchestration oflocal/regional trial team, setting priorities, and integration with other functions asnecessary throughout planning, conduct and closeout of trial. This requires coordinationof/with diverse and international trial team members,



and collaborationwith other external stakeholders.The complexity of the role is driven by the strict regulatory and ethicalrequirements.

Works on global clinical trials with multidisciplinary, international teams and with internal and external stakeholders including suppliers and investigational sites. Represents the company at internal and external meetings, e.g. with investigationalsites, patient organizations and/or regulatory agencies/inspectors. Critical contribution to speed and value of our clinical trials by providing input in strategic feasibility, maintaining relationship with sites and by implementing new innovative methods including digital innovations related to trial delivery.

Functional lead and/or project manager of local/regional trial team members and Other medical functions Local/ regional HP functions (including patient advocacy) Investigator and site staff Research networks Strong clinical trial project management experience. In-depth understanding ofproject management with emphasis on team work to promote high-performance teams Experience in Therapeutic Areas relevant in BI pipeline is desirable Understanding of local/regional major regulations Accelerates the delivery of innovative new therapies while bringing the best trialexperience to sites and patients

- Clinical development of a substance occurs within Medicine Excellence KPIs, qualityand budget given by IU and HPBU
- BI sponsored trials conducted according to applicable regulations and BI SOPs/procedures safeguard patient safety / well-being, and data quality and integrity
- Risk management at local/regional level allowing development of a substance in linewith BI strategy Robust accountability to support local/regional trial oversight. Requires a university degree (e.g. Masters degree or comparabledegree) with several years relevant experience in required area.

Biomedical Life Sciences

Scientific and Operational Expertise: Demonstrates scientific and therapeutic knowledge and operational expertise across all aspects of clinical trial planning andexecution. Dimensions of trial complexity include protocol, patients, sites, Strategic and visionary thinker who is future focused, creative,courageous and able to navigate through ambiguity. provide risk-balanced solutions.

Project Management: Anticipates and resolves challenges and translates learnings to new projects.Takes smart risks. are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality.

System

One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law. #

📌 Clinical Research Coordinator, Medical Genetics (Burlington)
🏢 System One
📍 Burlington