CTM / Clinical Trial Manager

Joulé; Toronto; Hybrid; CAD 80,000 - 100,000; Full time

Job summary

A leading staffing agency in Toronto is looking for a Clinical Trial Manager to oversee clinical trials, ensuring compliance and efficient execution. This role requires a Master's degree and experience in project management, with a hybrid work model offering flexibility. Competitive hourly compensation ranges from $55 to $60, making it an appealing opportunity for qualified candidates.

Benefits

Health and welfare benefits

401(k) participation

Qualifications

• Experience in clinical trial project management required.
• Strong interpersonal and team collaboration skills essential.
• Understanding of local and global regulatory requirements necessary.

Responsibilities

• Oversee operational execution of clinical trials in compliance with regulations.
• Manage trial budgets and ensure timely updates.
• Communicate with stakeholders to maintain trial progress.

Skills

Strong Communication Skills

Project Management

Scientific and Operational Expertise

Education

University degree (Masters or comparable)

Job description

6 days ago Be among the first 25 applicants

Job Title : CTM / Clinical Trial Manager

Location : Toronto, Ontario

Type : Contract

Compensation : $55 - $60 hourly

Contractor Work Model : Hybrid

Clinical Trial Manager

Location : Hybrid, Metro Toronto (Burlington) - 50% per month onsite

September Start

12 months contract+ (through 2026)

Pay : $55 to $60 per hour

Job Description :

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.

The CTM provides leadership and direction to the R / OPU trial team for their

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. As leader of the R / OPU Trial Team, the CTM communicatestrial status to stakeholders, escalating issues as appropriate.

Trial Preparation Accountabilities :

Accountable for the trial activities for responsible R / OPU, including but not limited to :

• 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. Timely budget updatesbased on trial changes.
• 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; andoversight of trial preparation to ensure trial teammembers are aligned and on track.
• 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. MedicalAffairs, vendors if applicable).
• Development and implementation of country levelengagement plans, recruitment planning and riskmitigation. Co-ordinates development of country levelpatient facing documents in close collaboration withrelevant internal and external stakeholders. Reportspatient and site level feedback as strategic insight to contribute to improving trial design with a focus onpatient value
• Frontloading of activities where possible at the R / OPU level to facilitate efficiencies as well as toensure and leverage speed.
• Oversees outsourcing of vendor services in the R / OPUin accordance to operating models and governance.
• Ensure timely responses to questions from RegulatoryAuthority / Ethics Committee and other externalstakeholders.

Trial Preparation related performance indicators :

Adheres to trial planningand commitment as per MedExtarget KPIs. Core documentsfiled in Trial Master Fileas per planned timelines.Ensures timely update oftrial management systems.

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.

Trial ConductAccountabilities :

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.

Support CTL during investigator meetings

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 :

Trial meets mandatorycompliance requirements.

Regular reporting of trialbudget and mitigation ofsignificant budgetdeviations.

Documented Local TrialOversight Meetings.

Timely availability of coredocuments.

Timely responses toauthority and ethicsrequests.

Vendor services proceedwithout interruption, andall issues are promptlyescalated and documented.

Trial target commitmentsmet.

Trial Closeout and ReportingAccountabilities

Ensures timely cleaning and delivery of clinicaltrial data.

Responsible for timely, complete and compliantarchiving of allrelevant R / OPU documents in the TMF,including all required documents from vendors.

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.

General accountabilities

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.

Supports CTL to ensure issues are raised to Evidenceteam for timely action or mitigation.

Performance Indicators

Regular communicationmaintained with trial team,internal and externalpartners.

Leadership Competencies

Creates an environment that inspires, motivates, andempowers colleagues and promotes one common CD&Oidentity, contributing to acceleration of clinicaldevelopment timelines and value creation for patients

Fosters a learning culture in CD&O regions byencouraging continuous learning, sharing bestpractices, and learning from failures.

Embraces innovative approaches and technologies, aswell as creates and maintains a culture that drivesempowerment, smart risk taking and one common CD&Oidentity.

Performance indicators

Demonstration of clear,concise and effectivecommunication

Delivery of operationalaspects and CD&O RegionsTarget Operational Modelaligned to HPBU Intent, OneMedicine vision, and CD&OVision and Missions.

Evidence of effective teamwork& leadership, goaldelivery and efficientdelivery of operationalaspects aligned to the OneMedicine visions (includinggoals, risk, mitigation).Evidence of insightsincorporation that can beutilized to improve ourclinical development andcustomer experience.

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.

Job Complexity

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.

Interfaces

Functional lead and / or project manager of local / regional trial team members and

colleagues including but not limited to :

CD&O

Other medical functions

Local / regional HP functions (including patient advocacy)

CRO and other suppliers

Investigator and site staff

Research networks

Patient organizations (PO)

Job Expertise

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

Familiarity with guidelines and standard of care is desirable

Experienced in working with CROs and POs is desirable

Ability to build and maintain strong relationships of mutual value

Excellent influencing and communication skills

Job Impact

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

Strong accountability to support local / regional trial oversight.

Minimum Education / Degree Requirements

Degree / education : Requires a university degree (e.g. Masters degree or comparabledegree) with several years relevant experience in required area. Major focus : Biomedical Life Sciences

Required Capabilities (Skills, Experience, Competencies)

Strong Communication Skills : Demonstrates AAI approach and skills in complex cross functionalmatrix structures of the trial and extended team. Articulates and alignsbusiness strategy / plan on an ongoing basis, ensuring alignment between words andaction. Demonstrates active listening skills and cultural awareness.

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,

countries, vendors.

Leadership and Influence : Demonstrates skills and capabilities in addressing complexsituations, confidently setting direction for teams. Demonstrates leadershipbehaviours of supporting, connecting and empowering teams, providing future direction,demonstrating visionary and innovative thinking and inspiring teams to achieve acommon goal. Executes activities with a clear aim to deliver value to patients.

Strategic Mindset : Strategic and visionary thinker who is future focused, creative,courageous and able to navigate through ambiguity. Integrates study strategy withoverall TA portfolio. Embraces cross functional initiatives, applying innovative

learnings. Is results-oriented with a global mindset using analytical thinking to

provide risk-balanced solutions.

Coordination and Oversight : Collaborative leader who demonstrates skills and

capabilities in setting priorities, managing pace of activities, and efficient usage

of resources.

Project Management : Plans effectively, setting priorities, and defining actions. Makeseffective use of resources, and proactively strives for transparency and clarity toaccomplish the business deliverables. Translates complex situations to actionableparts. Anticipates and resolves challenges and translates learnings to new projects.Takes smart risks.

System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., 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.

System One is an Equal Opportunity Employer. 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.

Ref : #568-Clinical

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Seniority level

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