Study Manager – FSP

Thermo Fisher Scientific

. Contribute to delivering clinical studies on time, within cost and quality objectives, while ensuring inspection readiness .

Posted 9/23/2026full-timeRemote • Bulgaria, Romania, Serbia, Poland, HungaryMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical study management, including project planning, vendor oversight, and regulatory compliance. Proficient in managing study delivery processes, ensuring inspection readiness, and fostering cross-functional collaboration.

Highest-signal resume keywords

Clinical Trial ManagementProject Management SkillsICH-GCP KnowledgeVendor ManagementAgile Methodologies

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study Delivery ProcessesRegulatory RequirementsTrial Master File StandardsBudget ManagementData OversightRisk ManagementProtocol Deviation ManagementAnalytical SkillsQuality AssuranceCommunication Plans

Soft Skills

Leadership SkillsRelationship-BuildingProblem-SolvingMentoring SkillsInterpersonal Skills

Tools & Technologies

Microsoft OfficeExcelClinical Trial Management SystemsTracking ToolsETMF

Industry Keywords

Pharmaceutical EnvironmentClinical TrialsDrug Development ProcessGCP GuidelinesOperational Best Practices

About the role

Key responsibilities & impact

Contribute to delivering clinical studies on time, within cost and quality objectives, while ensuring inspection readiness
Drive continuous improvement initiatives and share best practices across the business
Partner with the Study Delivery Lead on end-to-end operational study delivery from setup through archival
Set up, maintain, and ensure completeness of internal systems, databases, tracking tools, and project plans
Work cross-functionally with internal and external partners on clinical study management activities across phases and therapeutic areas
Monitor study conduct and progress and identify, resolve, and escalate delivery risks and issues
Review key clinical documents, including protocols and informed consent forms
Lead development of study plans, including monitoring, vendor management, protocol deviation management, risk management, and communication plans
Facilitate and maintain meetings and interactions with regulatory, local operating company, quality assurance, CRO, and third-party vendor partners
Manage vendors and provide CRO oversight, including overseeing deliverables and delegated activities
Provide country oversight, tracking recruitment, data completeness, compliance, protocol deviations, risks, regulatory approvals, and import license status
Coordinate study-related activities and manage study team communications, meetings, minutes, info-spaces, newsletters, action logs, team lists, and communication plans
Oversee delivery of clinical supplies, investigational products, and study materials; communicate risks and propose solutions
Provide data oversight and maintain eTMF completeness and quality for inspection readiness
Manage budget oversight, including task/change orders, expenses, system updates, agreements, and issue escalation
Contribute to agile squads and potentially serve as Scrum Master
Perform study activities independently across study types with limited instructions from the Study Delivery Lead
Mentor less experienced colleagues

Requirements

What you’ll need

University degree or equivalent, preferably in medical or biological science or a discipline associated with clinical studies
At least 3+ years of relevant work experience in a pharmaceutical/scientific environment
Knowledge of clinical trials and the drug development process
Excellent knowledge of ICH-GCP, clinical study delivery processes, regulations, operational best practices, and industry standards
Familiarity with key systems used in clinical trial delivery
Experience using an industry-accepted Trial Master File standard
Strong project management skills, preferably including analytical/financial skills
Good leadership skills
Excellent verbal and written communication in English
Excellent communication and relationship-building skills, including external service provider management
Knowledge of applicable clinical trial regulatory requirements, including GCP and ICH guidelines
Ability to manage multiple competing priorities with planning, time management, and prioritization skills
Ability to think independently, analyze and solve problems systematically and creatively, and take a risk-based approach
Confirmed expertise and seniority within the area and function
Logical/analytical thinking, pattern and outlier identification, quality mindset, critical sense, and attention to detail
Effective training and mentoring skills
Very good understanding of project planning and management principles
Knowledge of project finance and accounting principles, including budgets, invoices, cross-charges, and expense reports
Excellent comprehension of Microsoft Office tools, including Excel, PowerPoint, Word, and Outlook
Knowledge of advanced Excel, timelines/budget tracking systems, and clinical trial management systems
Excellent stakeholder management and communication skills, including oral and written communication
Outstanding interpersonal skills
Excellent networking and stakeholder-influence capabilities
Ability to facilitate and lead cross-functional meetings, challenge inefficient ways of working, and act as a mediator
Results-driven and efficient; motivated and dynamic personality
Ability to work in a changing and challenging environment and coach study team members
Ability to work in cross-functional squads using an agile model
Team spirit and ability to work across cultures and geographies with awareness and understanding of cultural differences

Benefits

Comp & perks

Fully remote work arrangement
Standard Monday–Friday work schedule