Clinical Trial Manager
Location: Hybrid, Metro Toronto (Burlington) - 50% per month onsite
12 months contract
Pay: $50 to $60 per hour CAD based on years of education and experience
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 COMPANY’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 their assigned clinical trial/s according to defined milestones and key performance indicators (e.g. Medicine Excellence KPIs -MedEx). They are responsible for steering and directing 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 regional/local and global level.
The CTM is responsible for managing the planning, implementation, and tracking of the clinical trial process as well as risk mitigation. The CTM serves as a proactive member of the trial team, liaising closely with the Clinical Trial Leader (“CTL”) on all study-related issues. As leader of the R/OPU Trial Team, the CTM communicates trial 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 and according to the trial protocol by overseeing CRO and internal team activities.
- Creation, management and review of the R/OPU trial budget to ensure appropriate level of financial oversight and planning accuracy. Timely budget updates based on trial changes.
- Appropriate trial-specific training of R/OPU internal and external partners is performed in line with Trial Training Plan.
- Accurate planning and co-ordination of operational feasibility of trial timelines for their R/OPU; and oversight of trial preparation to ensure trial team members are aligned and on track.
- Verifies and provides input into the country and site level feasibility and OPU commitment (site and patient commitment). Finalize and validate site selection using available data sources and local insights/expertise, in collaboration with other functions (i.e. Medical Affairs, vendors if applicable).
- Development and implementation of country level engagement plans, recruitment planning and risk mitigation. Co-ordinates development of country level patient facing documents in close collaboration with relevant internal and external stakeholders. Reports patient and site level feedback as strategic insight to contribute to improving trial design with a focus on patient value
- Frontloading of activities where possible at the R/OPU level to facilitate efficiencies as well as to ensure and leverage speed.
- Oversees outsourcing of vendor services in the R/OPU in accordance to operating models and governance.
- Ensure timely responses to questions from Regulatory Authority/Ethics Committee and other external stakeholders.
Trial Preparation related performance indicators:
- Adheres to trial planning and commitment as per MedEx target KPIs. Core documents filed in Trial Master File as per planned timelines. Ensures timely update of trial management systems.
- Regular communication maintained with local trial team, internal and external partners.
- Implementation and incorporation of patient centric initiatives to optimize trial delivery and bring value to patients. Engagement plans in place, including recruitment and contingency planning.
Trial Conduct Accountabilities:
- Maintains oversight during clinical trial conduct including adherence to GCP and all global and local regulatory requirements; compliance with SOPs and continuous risk monitoring/mitigation. In collaboration with other functions, ensures budget oversight, including support of regular clinical quality monitoring, and safety reporting.
- Monitor progress of patient recruitment endpoints and proactively update and action contingencies throughout trial conduct.
- Support CTL during investigator meetings
- Establish and maintain relationships with external experts, investigational sites, Patient Organizations and other stakeholders by coordinating and ensuring cross-functional collaboration amongst CD&O and appropriate functions (i.e Medical Affairs, Market Access, PAR) on regional/ local level.
- Active participation in the CD&O community with a special focus on participating in the CTM network, to actively contribute to functional excellence.
Trial Conduct related performance indicators:
- Trial meets mandatory compliance requirements.
- Regular reporting of trial budget and mitigation of significant budget deviations.
- Documented Local Trial Oversight Meetings.
- Timely availability of core documents.
- Timely responses to authority and ethics requests.
- Vendor services proceed without interruption, and all issues are promptly escalated and documented.
- Trial target commitments met.
Trial Closeout and Reporting Accountabilities
- Ensures timely cleaning and delivery of clinical trial data.
- Responsible for timely, complete and compliant archiving of all relevant R/OPU documents in the TMF, including all required documents from vendors.
- Ensures timely submission of the CTR to Regulatory Authority/Ethics Committee and other external stakeholders as required by local regulations
- Shares information on trial results with Investigational sites and, if applicable, Patients (e.g. lay summaries).
Minimum Education/Degree Requirements*
Degree /education: Requires a university degree (e.g. Masters degree or comparable degree) 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 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.
Scientific and Operational Expertise: Demonstrates scientific and therapeutic
knowledge and 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, confidently setting direction for teams. Demonstrates leadership behaviours of supporting, connecting and empowering teams, providing future direction, demonstrating visionary and innovative thinking and inspiring teams to achieve a common 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 with overall 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. 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.
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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