Country Trials Manager II
The Country Trials Manager is responsible for study startup deliverables for assigned studies at a country level that are of moderate to high complexity. The Country Trials Manager partners with the Study Start Up Project Manager, Study Manager, Site Relationship Partner, Site Operations and 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
Responsible for Study and Site Start-up on a Country level:
- Manages the study start up 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 start up 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 Operations and 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 HAs 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.
- 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.
- 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
- Mentors/coaches and helps onboard other Clinical Trials Managers
- Identifies and communicate study startup mitigation plans that may be effective across country clusters
- Acts as a Subject Matter Expert in areas linked to study start up
- Leads operational effectiveness initiatives at country/cluster level
Responsible for Study and Site Start-up Country Operational aspects:
- PTA and SIV report review
- Collects Country level documents (e.g. Insurance documents, LOA if required) required for submission/SIVs
- Support to EC/RA and other relevant (e.g. radiation, biobank) 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 Operations and 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
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 or equivalent or above
- Extensive 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.
- + 7 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
- Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization
Eligible for Employee Referral Bonus: YES
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