Country Trials Manager

Country Trials Manager 1

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Position Purpose: 

The Country Trials Manager is responsible for study startup deliverables for assigned studies at a country level of limited or moderate complexity. The Country Trials Manager partners with the Study Start Up Project Manager, Study Manager, Site Intelligence Lead, Site Relationship Partner, Site Activation Partner, Contracts Lead, Regulatory Affairs, CRO representatives and others as required. The Country Trials Manager provides leadership and country strategic planning and organization skills to ensure the delivery of operational Start up aspects of one or more studies, in accordance with the appropriate quality standards including ICH/GCP standards, SOPs, local operating guidelines and local regulatory requirements, as applicable.

Accountable for the execution of:

• Country level implementation of Startup and Site Activation Plans
• Country level Recruitment Strategy
• Timely and quality EC/RA Submissions 
• Communication with internal stakeholders as listed above to ensure efficient and timely study startup delivery at a country level

Organizational Relationships:

• Reports to Director of Clinical Site Operations (DCSO).
• All Country Study Team Members: (e.g., Study Activation and Operations Partner, SRP, SUPM, SM)
• Within Clinical Development and Operations: Start Up Project Management, Study Manager, Study Optimization, key partners
• supporting start-up (e.g., SRP, SAP, Site Intelligence Lead)
• Other: Regulatory Lead, Budget and Contract Lead, Field Medical Directors
• Externally: other stakeholders and 3rd party vendors as applicable

Role Responsibilities:

Responsible for Study and Site Start-up on a Country level:

• Manages the study startup 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 GSSO and Regulatory colleagues in 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 implementation at a country level.
• Provides input on country specific risks into preparation of Investigational Quality Management Plan, Study Monitoring Plans, ensures 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:

• PTA and SIV report review
• Supports with implementation of client Site Technology Experience systems (e.g. Shared Investigator Platform SIP, Centralized Account Management CAM)
• Collects Country level documents (e.g. Insurance documents, LOA if required) required for submission/SIVs
• Support to EC/RA and other relevant (e.g. identification of National coordinators, radiation, biobanking) submissions and deficiency/query responses for initial and subsequent 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 ensure country level PTMF completeness during study startup
• Country level ICD creation and Global Review and Approval Form (GRAF) completion and site level ICD creation and GRAF completion, if applicable
• Country level IP/equipment/ancillary supplies management including Import/Export License management
• Provides support for the IIP process to Site Activation Partner
• Supports implementation of new tools and technologies (e.g. eConsent, eISF, Remote Source Access, remote 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

Qualifications:

BASIC QUALIFICATIONS

Training 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
• English and region/country local language is required

PREFERRED QUALIFICATIONS

Prior Experience

• + 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

Skills and Technical Competencies

• Expertise in the use of Site Activation tools

• Detail oriented & possesses technical expertise
• Ability to manage complex processes
• Ability to manage in a matrix environment
• Risk Identification & 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

Behavioral Competencies

• 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