Country Trials Manager, FSP

Responsible for Study and Site Start Up on a Country level:

• Manages the study start up (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 Startup and Recruitment milestones to Global Study Team during planning

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

• Highlights deviations and risks in startup 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.

• Attendance at SSU meetings. Ad-hoc member of the Operational Study Team Meetings

• Leader of the Local Study Team (core members: Country Trials Manager, Site Relationship Partner, Site Activation Partner, ad hoc members: Contracting, Regulatory, Medical Affairs colleagues and other key stakeholders as required)

• Ensures timely communication bidirectionally between the global and local study team

• Provides protocol level guidance and support to responsible Local Study Team members as applicable

• Liaise 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

• Ability to successfully liaise with global roles in support of successful CT (clinical trial) implementation at a country level

• Provides input on country specific risks into preparation of Investigational Quality Management Plan, Study Monitoring Plans, 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 Study Startup

• 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

Responsible for Study and Site Start Up Country Operational aspects:

• Pre-Trial Assessment (PTA) and Site Initiation Visit (SIV) report review

• Supports with 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

• Support to 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 Clinical Study Agreement and budget negotiations and setup of site payment tools

• Country and site level PTMF setup

• Provides country level documents to PTMF and Investigator Site File (ISF) and ensures country level PTMF completeness during study startup

• 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

• 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, etc.)

• Identify/contract/Manage/Oversee local vendors or facilities as per protocol

• Investigator Meeting support

General:

• Complete training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, system, and process related training

• Adhere to EP and Client SOPs and processes

Skills and Education:

• • A scientific or technical degree is preferred along with extensive knowledge of clinical trial methodology. In general, candidates for this job would hold the following levels of education/ experience: BS/BSc/MS/MSc; a nursing diploma or associate degree in nursing may also be considered with extensive clinical trial experience
• • Operational clinical trial experience
• • Working knowledge of Good Clinical Practice, clinical and regulatory operations and environment in countries under responsibility
• • Fluency in English and region/country local language are required
• • Prior Experience Preferred:

• + 5 years of clinical research experience and/or study management/startup project manager experience

- Demonstrated knowledge of site selection, site activation, site readiness interdependencies

- Demonstrated knowledge of clinical trial methodology and the drug development process

- Demonstrated experience leading cross functional teams

- Demonstrated experience in Project Management and Quality management

- Demonstrated experience in a matrix management environment

• Expertise in the use of Site Activation tools

• Detail oriented and possesses technical expertise (e.g., spreadsheets, metrics, and data flow management)

• Ability to manage complex processes

• Ability to manage in a matrix environment

• Risk Identification and Mitigation

• Strategic Planning, Analytical and Problem-Solving Skills

• Critical Path Analysis

• Excellent communication skills, both written and verbal

• Ability to adapt to changing technologies and processes

• Seeks to develop an integrated view of key issues to shape decisions and strategy development

• Proactively manages change by identifying opportunities and coaching self and others through the change

• Ability to introduce new ideas and implement them

• Effectively overcoming barriers encountered during the implementation of new processes and systems

• Builds effective relationships with customers and other stakeholders

• Works well across country boundaries, respects communication and cultural differences in interpersonal relationships

• Effective verbal and written communication skills in relating to colleagues and associates, both inside and outside of the organization