Country Study Operations Manager / Clinical Trial Manager - Canada - FSP
Parexel · Ontario, Canada
- Hybrid
- Full-time
- $95,000 / year
- Ontario, Canada
Job highlights
- Manage country-level clinical trial operations.
- Lead local study teams and external partners.
- Ensure operational delivery from startup to close.
- Oversee budgets, timelines, risks, and quality.
- Implement new technologies and compliance standards.
About the role
Job Summary
The Country Study Operations Manager I is responsible for study and regional or specific country level activities from study startup through conduct and study close on one or more studies. This role provides leadership, strategic planning, and organization skills to ensure the operational delivery of tasks.
Key Accountabilities
Study Management Oversight
- Supports Global Study Managers (GSMs), other SOMs, and the larger study management delivery by leading specific parts of the project, driving specific countries, executing tasks of moderate complexity, and developing solutions to problems as needed.
- Serves as leader of the local study team (core members, ad hoc members, and other key stakeholders as required) on one or more studies.
- Oversees the preferred Contract Research Organization (pCRO) and/or Country Trial Manager (CTM)/Site Care Partner (SCP) for assigned studies at country level in accordance with the overall project plan, and manages accurate country level plans (e.g., timelines, budget, risk, and quality plans).
- May manage the study start up process in assigned countries [where the Start Up Project Manager (SUPM) is not assigned] and/or oversee the pCRO responsible for these activities.
- Liaises with SCP, Lead SCP, Site Activation Partners (SAPs), and regulatory colleagues in country to agree on submission strategy to Health Authorities (HAs) and Ethic Committees (ECs).
- Provides country level input on startup and recruitment milestones to GSM.
- Collaborates with accountable roles to identify and manage deviations and risks in study startup and execution and implements mitigation strategies.
- May be responsible and accountable for, as designated by the GSM: Regional, country and study level recruitment strategy, support of study level plans, communication with local team and stakeholders, study and/or country vendor management and oversight, and coordination of regional and site quality events.
Study Management Operations
- Acts as the point of contact for all study level questions for the local study team, ensuring resolution at the lowest possible level, and escalating to appropriate global roles and teams when needed.
- May lead operational effectiveness initiatives at country or regional level.
- Utilizes country roles and expert roles to provide global teams with local intelligence and operational nuances.
- Provides input on country level per subject costs, local vendor costs, and other fees.
- Utilizes country intelligence to provide input on country-specific risks into the Investigational Quality Management Plan and Study Monitoring Plan, and ensures Trial Master File (TMF) completeness and oversight of compliance activities.
- Supports implementation of client’s site technology experience systems.
- Supports implementation of new tools and technologies (e.g., eConsent, eISF, remote source access, remote SDV/SDR, iConnect, decentralized trial options).
Compliance with Parexel Standards
- Complies with required training curriculum.
- Completes timesheets accurately.
- Submits expense reports accurately.
- Updates CV as required.
- Maintains working knowledge of and complies with Parexel processes, ICH-GCPs, and other applicable requirements.
Key skills/competency
- Clinical Trial Management
- Study Operations
- Country Operations
- Risk Management
- Strategic Planning
- Vendor Management
- Stakeholder Communication
- Regulatory Compliance
- ICH-GCP
- Problem Solving
Skills & topics
- Clinical Trial Management
- Study Operations Manager
- Country Operations Manager
- Clinical Research
- Project Management
- Regulatory Affairs
- ICH-GCP
- Risk Management
- Vendor Management
- Healthcare Operations
How to get hired
- Tailor your resume: Highlight your 3-5 years of clinical trial study management experience and comprehensive knowledge of clinical operations and ICH-GCP.
- Showcase operational expertise: Emphasize your demonstrated experience in managing country-level operational activities, vendors, and risk mitigation strategies.
- Demonstrate leadership: Illustrate your ability to lead local study teams and collaborate effectively in a matrix environment.
- Prepare for interviews: Be ready to discuss your analytical skills, problem-solving abilities, and adaptability to new technologies and processes.
- Understand Parexel: Research Parexel's mission, values, and commitment to innovation in clinical research to align your application.
Technical preparation
Master study and site dashboards.,Understand clinical trial methodology.,Familiarize with ICH-GCP guidelines.,Learn about new trial technologies.
Behavioral questions
Describe managing a complex project.,How do you handle unexpected issues?,Tell me about your leadership experience.,How do you adapt to change?
Frequently asked questions
- What specific experience is required for the Country Study Operations Manager role at Parexel?
- The Country Study Operations Manager position requires 3-5 years of clinical trial study management experience. A Bachelor's degree with a minimum of 7 years of relevant operational clinical trial experience, or a Master's degree with a minimum of 6 years of relevant experience, is necessary. A scientific or technical degree is preferred.
- What are the key responsibilities of a Country Study Operations Manager at Parexel?
- Key responsibilities include overseeing country-level study operations from startup to close, leading local study teams, managing preferred Contract Research Organizations (pCROs) and Country Trial Managers (CTMs), developing country-specific plans (timelines, budgets, risks), liaising with regulatory authorities, and ensuring compliance with Parexel standards and ICH-GCP.
- Is this a remote or on-site position?
- While the job description indicates the need for travel and the ability to work outside core business hours to support global trials, it does not explicitly state if the role is remote, hybrid, or on-site. Candidates should inquire about the specific work arrangement during the application process.
- What skills are most important for success in this Country Study Operations Manager role?
- Essential skills include expertise in study and site dashboards, detail orientation, ability to manage complex processes, risk identification and mitigation, strategic planning, analytical and problem-solving skills, adaptability, strong communication, and the ability to operate effectively in a matrix environment.
- How does Parexel support the implementation of new technologies in clinical trials?
- Parexel actively supports the implementation of new tools and technologies, such as eConsent, eISF, remote source access, remote source data verification/review (SDV/SDR), iConnect, and decentralized trial options, to enhance study operations and patient experience.
- What is the expected level of interaction with regulatory authorities for this role?
- The Country Study Operations Manager will liaise with Site Activation Partners (SAPs) and regulatory colleagues in the country to agree on submission strategies with Health Authorities (HAs) and Ethics Committees (ECs), playing a key role in country-level regulatory interactions.
- Does this role involve vendor management?