Clinical Trial Manager - Associate

Job Title: Clinical Trial Manager - Associate
Location: Burlington, Ontario

Type: Contract
Compensation: $45 CAD
Contractor Work Model: Hybrid

Clinical Trial Manager - Associate
Location: Hybrid, Metro Toronto (Burlington) - 50% per month onsite

May Start
12 months contract+ (through 2026)

Job Description:
The Clinical Trial Manager - Associate ("CTM-A") supports the operational set-up, execution and delivery of their assigned clinical trials at the local level. The CTM-A contributes to delivery of the client's pipeline through efficient execution of trials that bring speed & value to participating patients and sites according to defined milestones and key performance indicators (e.g. Medicine Excellence KPIs -MedEx). They will support clinical trial activities, including patient and site engagement activities, direct communication and interaction with multiple internal and external stakeholders (e.g. investigative sites) and trial team members at a local and global level. The CTM-A is responsible for supporting the planning, implementation, and tracking of the clinical trial process as well as risk mitigation. The CTM-A serves as a proactive member of the trial team, liaising closely with the Clinical Trial Manager (“CTM”) on all study-related issues.

Accountabilities:

Related performance indicators

• Provides support to the CTM to ensure that assigned Canadian trials are completed on time, within budget, and with high quality.
• Provides CTM with support to accelerate trial start-up, by maximally front loading activities where possible.
• Support CTM to oversee trial related deliverables in start up, conduct and close out phases of a trial in partnership with CRO.

As appropriate, based on delegation of tasks to meet the following performance indicators:

• Efficient recruitment of qualified investigative sites/site staff that represent regions of Canada; All regulatory requirements for study start up are satisfied prior to trial/site initiation; Appropriate drug supply is available at site for site initiation/throughout trial; All sites are appropriately trained before and during the trial; Sites initiated in a timely manner; Recruitment commitments are achieved on time; Oversee collection and transfer of high quality data; Documentation of appropriate trial oversight; permanent inspection readiness for all relevant trial aspects.

Ensures adherence to governmental regulations, international guidelines, and company Standard Operating Procedures in the conduct of clinical trials.

Trials conducted per ICH/GCP, Health Canada Division 5 requirements.
Personal training completed in timely manner.

Supports optimal patient and site engagement in accordance with patient and site engagement playbook and/or trial specific patient and site engagement plan.

Robust patient and site engagement plans for Canadian trials.

Fosters a learning culture in CD&O regions by encouraging continuous learning, sharing best practices, and learning from failures. Embraces innovative approaches and technologies, as well as creates and maintains a culture that drives empowerment, smart risk taking and one common CD&O identity.

May contribute to non trial projects as assigned.

As appropriate, based on assignment.

Regulatory and / or Organisational Requirements:

• Health Canada Division 5; ICH/GCP

Job Complexity:

• Supports the CTM 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.
• Take on tasks delegated by the CTM including those related to patient and site engagement.
• Ability to identify potential risks and monitors a course of action in consultation with the CTM.
• Able to balance priorities to ensure tasks are completed with quality and on time (e.g site initiation,DBL, site close out).

Interfaces:
Medical Affairs, Drug Regulatory Affairs, Pharmacovigilence 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
Clinical Research Environment:

• At entry, demonstrates a working or functional understanding of the requirements of the clinical research environment (Sponsor, Investigator and Regulatory).

Job Impact:
As a support to the CTM, the CTM-A works toward the successful completion of clinical trials in Canada.

Minimum Education/Degree Requirements:

• University degree qualified or at least 5 years professional experience in the area of clinical trials.
• Strong and proven track record with a background in administrative management of CTs. Extensive working experience in cross functional project work.

Required Capabilities (Skills, Experience, Competencies)
Strong Communication Skills:

• Demonstrates AAI approach and skills in complex cross-functional matrix structures of the trial and extended team.
• Articulates and aligns business strategy/plan on an ongoing basis, ensuring alignment between words and action.
• Demonstrates active listening skills and cultural awareness.
• Ability to have a positive impact on others, to persuade or convince them in order to gain their support.

Scientific and Operational Expertise:

• Demonstrates operational expertise across all aspects of clinical trial planning and execution.
• Dimensions of trial complexity include protocol, patients, sites, countries, vendors.

Leadership and Influence:

• Demonstrates skills and capabilities in addressing complex situations.
• Demonstrates leadership behaviors of supporting, connecting and enable teams, demonstrating innovative thinking to support trial implementation.
• 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.
• 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 team member 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.
• Makes effective use of resources, and proactively strives for transparency and clarity to accomplish the business deliverables.
• Translates complex situations to actionable parts.
• Anticipates and resolves challenges and translates learnings to new projects. Takes smart risks.

Digital expertise:

• Displays the ability to use technologies to access information, be creative, innovative, solve problems, communicate, navigate, learn & apply in a digital environment.

Regulations:

• Good understanding of regulatory framework in which CTM-A is operating (e.g. local requirements, ICH-GCP, appropriate SOPs, BPs etc., List of Essential Elements and documents Naming Convention for filing, etc.)

Relevant language skills:

• Fluent in written and spoken English

Effective cross-functional collaborations:

• Ability to develop and maintain relations, alliances, and coalitions within and outside the organization and to use them in order to obtain information, support and cooperation

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.

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Ref: #568-Clinical