Country Trials Manager

Canada, Remote
Canada

**Job ID** R0000012476

**Category** Clinical Trials

**ABOUT THIS ROLE**:
**Accountability**

**Activities**

may include but are not limited to the following

**SSU Country**
**Level Delivery**
- ________________
- Oversees the execution of:

- Country level implementation of Start Up and Site Activation Plans
- Country level Recruitment Strategy
- Timely and quality Ethics Committee (EC) and Regulatory Authority (RA) Submissions
- Communication with internal stakeholders to ensure efficient and timely study start up delivery at a country level

Manages the SSU process in countries assigned

Supports the Country/investigator outreach process, site identification and feasibility ensuring countries/sites can meet all study protocol requirements Provides country level input on SSU and Recruitment milestones to Global Study Team during planning

Is accountable for delivery of SSU and site activation for assigned studies at country level in accordance with the overall project plan, and manages and maintains accurate country level plans (e.g., timelines, budget, risk, and quality plans)

Highlights deviations and risks in SSU and site activation plans to relevant parties, develops, and implements mitigation strategies as required. Is also accountable for resolution of Site Activation escalations to Study Teams including offering options for mitigation (both at the study and site level. Attends SSU meetings. Ad-hoc member of the Operational Study Team

**SSU Country Level Operations**

Meetings

Serves as leader of the Local Study Team (core members: CTM, Site Relationship Partner, Site Activation Partner, ad hoc members: Contracting, Regulatory, Medical Affairs, and other key stakeholders as required). Ensures timely communication bidirectionally between the global and local study teams. Provides protocol level guidance and support to responsible Local Study Team members as applicable. Liaises with Global Site and Study Operations (GSSO) and Regulatory colleagues and country colleagues to agree on submission strategy to Health Authorities and Ethic Committees. Provides Global Teams with local intelligence. Acts as the main point of contact for all study-level questions for the Local Study Team, liaising with and escalating to appropriate global roles/teams. Follows up on country level issue status to ensure resolution. Identifies start up country level trends to improve start up processes as needed. Ensures compliance to relevant Global and Local, internal and external processes. Successfully liaises with global roles in support of successful clinical trial implementation at a country level. Provides input on country specific risks into preparation of Investigational Quality Management Plan, Study Monitoring Plans, and ensures Client Trial Master File (PTMF) completeness and oversight of all relevant compliance activities for allocated studies. Ensures audit/Inspection readiness during start-up. May act as a Subject Matter Expert on Client systems and processes. Manages country level Significant Quality Events occurring during Site and SSU. Leads effective site recruitment planning to allow for implementation of plans at the country and site level, consistent with global plan and local targets. Provides input on Country level Per Subject Costs, local vendor costs and other fees where applicable Conducts Pre-Trial Assessment (PTA) and Site Initiation Visit (SIV) report review. Supports implementation of Client's Site Technology Experience systems [e.g., Shared Investigator Platform (SIP), Centralized Account Management (CAM)]Collects Country level documents [e.g., Insurance documents, Letter of Agreement (LOA) if required] required for submission/SIVs. Supports Ethics Committee/Regulatory Authority (EC/RA) and other relevant (e.g., identification of National coordinators, radiation, biobanking) submissions and deficiency/query responses for initial and subsequent Clinical Study Agreement (CSA) submissions. Supports CSA and budget negotiations and setup of site payment tools. Completes Country and site level PTMF set up. Provides country level documents to PTMF and Investigator Site File (ISF) and ensures country level PTMF completeness during SSU. Conducts Country level informed consent document (ICD) creation and Global Review and Approval Form (GRAF) completion and site level ICD creation and GRAF completion, if applicable
Provides Country level investigational product (IP)/equipment/ancillary supplies management including Import/Export License management Provides support for the Investigator Initiation Package (IIP) process to Site Activation Partner

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

Identifies/Contracts/Manages/Oversees local vendors or facilities as per protocol

Provides Investigator Meeting sup