Dependency and Critical-Path Management

• 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.

Stakeholder Communication

• 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.

Vendor and Resource Management

• 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.

Document and Quality Management

• 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.

Knowledge, Qualifications, and Skills

• 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 coordinating decentralized, hybrid, virtual, and/or traditional site-based studies is preferred.
• 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.
• Knowledge of European clinical research and data-privacy requirements is preferred.
• 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. Proficiency in an additional language is an advantage.
• Ability and willingness to consistently work European business hours, with occasional flexibility for meetings involving other global time zones.
• Ability to work independently and communicate proactively in a fully remote environment.
• Project Management Professional certification or another recognised project-management qualification is preferred.
• Proficiency with project-management tools, clinical trial systems, and collaboration platforms.

Competencies

• Teamwork: Works effectively within cross-functional and globally distributed teams while encouraging collaboration and accountability.
• Commercial Awareness: Understands the financial and operational factors that contribute to organisational success and applies sound commercial judgment to study decisions.
• Decision-Making: Gathers and evaluates relevant information, considers potential impacts, and makes timely, well-supported decisions.
• Results Orientation: Establishes realistic and achievable goals, defines the steps required to meet them, and maintains accountability for results.
• Problem-Solving: Uses critical thinking, available information, and cross-functional input to identify root causes and implement effective solutions.
• Organisational Excellence: Prioritises and manages multiple studies, responsibilities, and deadlines while delivering accurate and timely results.
• Sponsor Orientation: Understands Sponsor needs, communicates transparently, and maintains focus on delivering value and meeting contractual commitments.
• Cultural Competence: Works effectively and respectfully with stakeholders across diverse cultures, countries, backgrounds, and working styles.
• Adaptability: Responds constructively to changing study requirements, priorities, timelines, and business needs while maintaining focus on quality and delivery.