Country Study Operations Manager

This is a fully remote position, open to applicants in Canada.

📋 Description

• Accountable for managing and overseeing study and regional/country level activities from study initiation through execution and closure.

• May oversee the study startup process in assigned countries (where a Study Unit Project Manager is not designated) and/or supervise the pCRO responsible for these tasks as necessary.

• Supports the Country/investigator outreach process, site identification, and feasibility through the Site Care Partner/Country Trial Manager or pCRO, ensuring that countries/sites can fulfill all study protocol requirements.

• Provides country-specific insights on Startup and Recruitment milestones as supplied by the pCRO and/or Country Trial Manager/Site Care Partner to the Global Study Manager during planning.

• Responsible for overseeing the pCRO and/or Country Trial Manager/Site Care Partner for assigned studies at the country level, in line with the overall project plan, while managing and maintaining accurate country-level plans (e.g., timelines, budget, risk, and quality plans).

• Collaborates with relevant roles to identify and manage deviations and risks during study startup and execution, implementing mitigation strategies as necessary.

• Also responsible for resolving Site Activation escalations with Study Teams, including providing options for mitigation.

• Acts as the leader of the Local Study Team (core members include: (Lead) Site Care Partners, Clinical Trial Assistants, with additional members such as ICL, Site Activation Partner, CTRO, Local Regulatory, Medical Affairs colleagues, and other key stakeholders as needed).

• Ensures compliance with relevant Global and Local, internal and external regulations and requirements.

• Facilitates timely communication in both directions between the global and local study team.

• Provides protocol-level guidance and support to designated Local Study Team members as appropriate.

• Coordinates with Site Care Partner, Lead Site Care Partner, Site Activation Partners, and Regulatory colleagues in-country to finalize submission strategies to Health Authorities and Ethics Committees.

• Utilizes roles in countries, such as Lead Site Care Partner and expert roles like Contracts Leads, Site Activation Partners, to furnish the Global Teams with local insights and operational nuances to consider.

• Serves as the study-level contact for all inquiries from the Local Study Team, ensuring resolution at the lowest possible level, and when necessary, liaising with and escalating to appropriate global roles/teams.

• Monitors region/country-level issue statuses to guarantee resolution.

• Identifies country-level trends to enhance process deliverables as needed.

• Leverages country intelligence to contribute insights on country-specific risks during the preparation of the Investigational Quality Management Plan and Study Monitoring Plans, ensuring the completeness of PTMF and oversight of all compliance activities for assigned studies.

• Ensures audit/inspection readiness throughout startup and execution phases.

• Manages relevant Quality Events with the pCRO and local team as applicable.

• Coordinates effective site recruitment planning to enable the implementation of plans at both country and site levels, in alignment with the global plan and local targets.

• Responsible for driving and ensuring the delivery of data cleaning outputs for the pCRO and sites as applicable.

• Provides input on country-level per subject costs, local vendor expenses, and other fees where relevant.

• May serve as a Subject Matter Expert.

• May lead initiatives aimed at enhancing operational effectiveness at the country or regional level.

• Responsible for reviewing PTA and SIV reports completed by the Site Care Partner.

• Aids in implementing the client’s Site Technology Experience systems (e.g., Shared Investigator Platform SIP, Centralized Account Management CAM).

• Supports submissions and responses to deficiencies/queries for initial and subsequent CTA submissions within required timelines for EC/RA and other relevant areas (e.g., radiation, biobank).

• Guides the pCRO and/or relevant internal study team members to ensure that PTMF setup meets study requirements and maintains oversight of PTMF completeness.

• Supplies country-level documents to PTMF and supervises the reconciliation and completeness of the Investigator Site File (ISF).

• Ensures the pCRO and/or relevant internal study team members manage the appropriate levels of IP/equipment/ancillary supplies, including Import/Export License management, with the assistance of Clinical Trial Assistants and other roles as needed.

• Supports the implementation of new tools and technologies (e.g., eConsent, eISF, Remote Source Access, remote SDV/SDR, iConnect, and the implementation of protocol-required decentralized trial options).

• Assists in identifying, developing, and managing contracts with local vendors or facilities as per protocol.

• Provides support and manages Investigator Meetings, including giving presentations as appropriate.

• Oversees local Investigator Meetings, including delivering presentations as suitable.

⛳️ Requirements

• A scientific or technical degree is preferred, along with a solid understanding of clinical trial methodology.

• A BS/BSc/MS/MSc degree is required.

• A BA/BS with 5+ years of relevant operational clinical trial experience is needed.

• An MBA/MS with 3+ years of relevant operational clinical trial experience is also acceptable.

• Proficient knowledge of Good Clinical Practice, clinical and regulatory operations, and the environment in countries under responsibility is essential.

• Demonstrated experience in clinical research and/or study management/startup project manager roles is required.

• Proven experience managing country-level operational activities and/or vendors is necessary.

• Experience in study and quality management within a matrix management environment is needed.

• Expertise in using study/site dashboard and reporting tools is essential.

• Detail-oriented with strong technical expertise.

• Capable of managing moderately complex processes.

• Ability to function effectively in a matrix environment.

• Skilled in risk identification and mitigation.

• Proficient in strategic planning, analytical thinking, and problem-solving skills.

• Knowledge of critical path analysis is essential.

• Excellent communication skills, both written and verbal, are necessary.

• Ability to adapt to evolving technologies and processes.

• Effective verbal and written communication skills for interacting with colleagues and associates.

🏝️ Benefits

• Various annual leave entitlements.

• A range of health insurance options to cater to you and your family’s needs.

• Competitive retirement planning options to maximize savings and plan confidently for the future.

• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a worldwide network of over 80,000 independent specialized professionals dedicated to supporting your and your family’s well-being.

• Life assurance.

• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.