Key Accountabilities:

Operational Study Management

Manage and oversee study activities at the regional and country level from startup through closeoutLead study startup processes in assigned countries or oversee pCRO responsibilities where applicableSupport site identification and feasibility through collaboration with Site Care Partners, Country Trial Managers, or pCROsProvide country-level input on startup and recruitment milestones to the Global Study ManagerOversee pCRO and/or Country Trial Managers for assigned studies, ensuring alignment with project plans and maintaining accurate country-level timelines, budgets, and risk/quality plansIdentify and manage deviations and risks in startup and execution; implement mitigation strategies and resolve site activation escalationsLead the Local Study Team, including core and ad hoc members such as Site Care Partners, Clinical Trial Assistants, Contracts Leads, Regulatory, and Medical AffairsEnsure compliance with global and local regulations and internal requirementsFacilitate timely and effective communication between global and local study teamsProvide protocol-level guidance to Local Study Team membersCoordinate submission strategies with Site Care Partners, Regulatory, and other country-level stakeholdersOffer local intelligence and operational insights to Global TeamsAct as the primary contact for study-level questions within the Local Study TeamMonitor and follow up on regional/country-level issues to ensure resolutionIdentify country-level trends and propose process improvementsContribute country-specific risk input to quality and monitoring plans; ensure completeness of Trial Master File (TMF) and compliance activitiesEnsure audit and inspection readiness during startup and conductManage quality events with pCRO and local teams as neededCoordinate site recruitment planning aligned with global and local targetsDrive delivery of data cleaning activities for pCRO and sitesProvide input on country-level per-subject costs, local vendor fees, and other applicable expensesMay serve as a Subject Matter Expert or lead operational initiatives at country or regional levelReview Pre-Trial Assessment (PTA) and Site Initiation Visit (SIV) reports completed by Site Care PartnersSupport implementation of sponsor site technology systems (e.g., SIP, CAM)Assist with submissions to Ethics Committees and Regulatory Authorities, including responses to queries and deficienciesEnsure TMF setup meets study requirements and maintain oversight of TMF and Investigator Site File (ISF) completenessOversee IP/equipment/supply management including import/export licensing with support from Clinical Trial AssistantsSupport implementation of new technologies (e.g., eConsent, eISF, remote SDV/SDR, decentralized trial tools)Assist with identification, contracting, and management of local vendors or facilitiesSupport and manage Investigator Meetings, including delivering presentations as needed

Basic Qualifications

Education and Training

Bachelor’s degree with 5+ years of relevant experienceMaster’s degree (MBA/MS) with 3+ years of relevant experienceScientific or technical degree preferredWorking knowledge of Good Clinical Practice (GCP), clinical and regulatory operations in assigned countriesFluency in English required

Experience

Proven experience in clinical research and/or study management, including startup project managementExperience managing country-level operational activities and vendorsFamiliarity with study and quality management in a matrixed environment

Skills and Technical Competencies

Proficient in study/site dashboards and reporting toolsStrong attention to detail and technical expertiseAbility to manage moderately complex processesEffective in matrix environmentsSkilled in risk identification and mitigationStrategic planning, analytical thinking, and problem-solvingCritical path analysisExcellent written and verbal communication skillsAdaptability to evolving technologies and processesStrong interpersonal communication across internal and external stakeholders

Preferred Qualifications

Behavioral Competencies

Comprehensive knowledge of own discipline and working knowledge of adjacent areasPromotes innovation and takes calculated risks to improve processesCapable of developing ideas and leading moderately complex projectsExercises sound judgment and serves as a resource for others

Work Schedule and Travel Requirements

Travel may be required for Investigator Meetings, Vendor Kick-Offs, and departmental meetingsMay be expected to work outside core business hours to support global trials or initiative
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