Clinical Project Manager

Curavit is a company focused on clinical research, and they are seeking a Clinical Project Manager. This role is responsible for the operational delivery of clinical research studies, managing multiple projects, and ensuring effective communication with Sponsors and stakeholders.

Responsibilities:

• Manage the simultaneous delivery of multiple clinical research studies using formal project-management practices
• Define and maintain study scope, timelines, milestones, deliverables, responsibilities, and dependencies
• Translate protocols, contracts, and Sponsor requirements into integrated operational project plans
• Manage study activities against the executed contract, statement of work, approved budget, and established timelines
• Identify out-of-scope activities and support the development of change orders, revised budgets, and schedule-impact assessments
• Support study proposals, feasibility assessments, budgets, statements of work, payment schedules, and bid-defense activities
• Serve as the operational owner and primary Sponsor contact for assigned studies
• Lead Sponsor meetings, study-team meetings, vendor meetings, investigator meetings, and governance meetings
• Coordinate deliverables across Clinical Operations, Digital Recruitment, Data Management, Biostatistics, Medical, Regulatory, Quality, Technology, Finance, and Medical Writing
• Monitor study progress, budgets, forecasts, resources, pass-through costs, and vendor performance
• Work with the Digital Recruitment and Clinical Operations teams to incorporate approved recruitment and enrollment activities into the overall study plan
• Review enrollment updates provided by Digital Recruitment and Clinical Operations teams and communicate potential effects on overall study timelines, budgets, and deliverables
• Coordinate with Clinical Operations to incorporate site start-up, activation, performance, and closeout milestones into the overall study plan and track related dependencies and risks
• Coordinate clinical systems, database development, data cleaning, database lock, statistical analysis, and final study reporting when included in scope
• Lead study closeout activities, including final deliverables, documentation reconciliation, lessons learned, and transition to archival
• Identify, assess, document, and manage study risks, issues, assumptions, and change requests
• Evaluate the impact of risks and changes on study scope, schedule, budget, resources, quality, and deliverables
• Develop mitigation and recovery plans and escalate significant concerns to the Sponsor or senior leadership
• Facilitate timely decision-making and ensure approved changes are documented, communicated, and implemented
• Identify and resolve conflicts, gaps in ownership, and barriers to study delivery
• Identify and manage study dependencies and critical-path activities
• Track Sponsor, site, vendor, and internal-team decisions, approvals, materials, and deliverables that may affect study timelines
• Communicate the impact of delayed dependencies and coordinate appropriate mitigation or recovery actions
• Maintain study action-item, decision, risk, and dependency trackers through completion
• Develop and maintain effective communication with Sponsors, study teams, sites, vendors, and external partners
• Serve as the primary operational point of contact for assigned study Sponsors
• Prepare and present study-status updates covering progress, timelines, budget, enrollment status, risks, decisions, dependencies, and upcoming activities
• Establish and manage stakeholder expectations regarding study scope, timelines, deliverables, responsibilities, and required decisions
• Build trusted Sponsor relationships while effectively managing competing priorities, changing requirements, and study escalations
• Collaborate effectively with stakeholders across different countries, cultures, functions, and time zones
• Coordinate with functional leads on the selection, onboarding, and management of study vendors and external partners and track vendor deliverables against the overall study plan
• Monitor vendors against agreed scope, timelines, budgets, service levels, quality requirements, and deliverables
• Review vendor proposals, estimates, invoices, and pass-through costs for alignment with approved study scope and budgets
• Forecast study resource requirements and collaborate with functional leaders to secure appropriate support
• Provide day-to-day guidance to assigned project coordinators, associate project managers, and other study-team members
• Ensure study documents and operational assets are developed, reviewed, approved, and appropriately maintained
• Ensure essential study documentation is accurate, complete, current, and inspection-ready in the Trial Master File and/or Investigator Site File, as applicable
• Ensure study activities are conducted in accordance with the protocol, ICH-GCP, applicable regulations, contractual requirements, and company procedures
• Partner with Quality and Clinical Operations to address protocol deviations, audit findings, compliance concerns, and corrective actions
• Support Sponsor audits, regulatory inspections, and inspection-readiness activities
• Ensure study processes, technical solutions, and operational procedures are documented and understood by relevant stakeholders

Requirements:

• Bachelor's degree in life sciences, healthcare, business, project management, or a related field. An equivalent combination of education and relevant experience may be considered
• Minimum of five years of clinical research or clinical trial operations experience, including responsibility for managing cross-functional study activities
• Demonstrated understanding of the end-to-end clinical trial lifecycle, including start-up, conduct, data management, and closeout
• Experience serving as the primary operational contact for Sponsors or clients
• Experience managing study timelines, budgets, forecasts, vendors, contracts, statements of work, and change orders
• Experience working with globally distributed Sponsors, study teams, sites, and vendors
• Strong working knowledge of ICH-GCP and applicable local and international clinical research requirements
• Ability to lead cross-functional teams and influence stakeholders without direct reporting authority
• Strong financial-management, organisational, analytical, negotiation, decision-making, and problem-solving skills
• Excellent written and verbal communication skills
• Professional fluency in written and spoken English is required
• Ability and willingness to consistently work US business hours, with occasional flexibility for meetings involving other global time zones
• Ability to work independently and communicate proactively in a fully remote environment
• Proficiency with project-management tools, clinical trial systems, and collaboration platforms
• Experience coordinating decentralized, hybrid, virtual, and/or traditional site-based studies is preferred
• Knowledge of US clinical research and data-privacy requirements is preferred
• Project Management Professional certification or another recognised project-management qualification is preferred
• Proficiency in an additional language is an advantage