Country Trials Manager Jobs

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

Role Responsibilities

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

• 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).
• Ensures compliance to relevant Global and Local, internal and external processes.
• Supports the Country/investigator outreach process, site identification and feasibility ensuring countries/sites can meet all study protocol requirements
• Provides input on Country level Per Subject Costs, local vendor costs and other fees where applicable
• Ensures timely communication bidirectionally between the global and local study team.
• Ensures audit/Inspection readiness during start-up.
• 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).
• Manages country level Significant Quality Events occurring during Site and Study Startup
• Provides protocol level guidance and support to responsible Local Study Team members as applicable.
• May act as a Subject Matter Expert on client systems and processes
• 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).
• Attendance at SSU meetings. Ad-hoc member of the Operational Study Team Meetings.
• Ability to successfully liaise with global roles in support of successful CT implementation at a country level.
• Liaise with GSSO and Regulatory colleagues in country colleagues to agree on submission strategy to Health Authorities and Ethic Committees.
• 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 country level input on Startup and Recruitment milestones to global Study Team during planning.
• 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.
• 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.
• Manages the study startup process in countries assigned.

Responsible For Study And Site Start-up Country Operational Aspects

• 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 with implementation of client Site Technology Experience systems (e.g. Shared Investigator Platform SIP, Centralized Account Management CAM)
• Country level IP/equipment/ancillary supplies management including Import/Export License management
• Investigator Meeting support
• Identify/contract/Manage/Oversee local vendors or facilities as per protocol
• Country level ICD creation and Global Review and Approval Form (GRAF) completion and site level ICD creation and GRAF completion, if applicable
• Provides support for the IIP process to Site Activation Partner
• Provides country level documents to PTMF and Investigator Site File (ISF) and ensure country level PTMF completeness during study startup
• PTA and SIV report review
• Collects Country level documents (e.g. Insurance documents, LOA if required) required for submission/SIVs
• Supports Clinical Study Agreement and budget negotiations and setup of site payment tools
• 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.)
• Country and site level PTMF setup

Qualifications

BASIC QUALIFICATIONS

Training and Education

• Operational clinical trial experience
• 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.
• 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

• Demonstrated knowledge of clinical trial methodology and the drug development process
• Demonstrated knowledge of site selection, site activation, site readiness interdependencies
• Demonstrated experience in Project Management and Quality Management
• + 5 years of clinical research experience and/or study management/startup project manager experience
• Demonstrated experience in a matrix management environment
• Demonstrated experience leading cross functional teams

Skills And Technical Competencies

• Ability to manage complex processes
• Expertise in the use of Site Activation tools
• Critical Path Analysis
• Excellent communication skills, both written and verbal
• Strategic Planning, Analytical and Problem-Solving Skills
• Ability to manage in a matrix environment
• Risk Identification & Mitigation
• Detail oriented & possesses technical expertise
• Ability to adapt to changing technologies and processes

Behavioral Competencies

• Proactively manages change by identifying opportunities and coaching self and others through the change
• Builds effective relationships with customers and other stakeholders
• Works well across country boundaries, respects communication and cultural differences in interpersonal relationships
• Effectively overcoming barriers encountered during the implementation of new processes and systems
• Ability to introduce new ideas and implement them
• Seeks to develop an integrated view of key issues to shape decisions and strategy development
• Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization