Study Manager - FSP - EMEA

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Thermo Services (Hungary) Kft.
Munkavégzés helye

Budapest
Profession Prémium

Nézd meg, mennyire felelsz meg ennek az állásnak. Mennyire passzolok?

Munkaidő, foglalkoztatás jellege
- Alkalmazotti jogviszony
- Általános munkarend
Elvárások
- Angol felsőfok
- 3-5 év tapasztalat
- Egyetem

Állás elmentve

A hirdetést eltávolítottuk a mentett állásai közül.

Responsibilities

Oversight of study eTMF completeness
Driving continuous improvement initiatives within remit of expertise
Sharing best practices across business
Increasing operational delivery efficiency
End-to-end operational study delivery activities from study setup to study archival
Setting up, maintaining and ensuring completeness of internal systems, databases, tracking tools and project plans
Clinical study management activities for in-house and outsourced studies across all phases and therapeutic areas
Monitoring study conduct and progress
Identifying, resolving and escalating risks and issues impacting study delivery
Reviewing key clinical documents including Protocol and Informed Consent Forms
Leading development of study plans for external and internal use
Facilitating and maintaining interactions and meetings with internal and external partners
Vendor management and CRO oversight
Country oversight including tracking recruitment progress, data completeness and compliance
Coordinating study-related activities and managing study team communication
Overseeing delivery of clinical supplies, investigational products and study materials
Data oversight to ensure study inspection readiness including eTMF completeness
Budget oversight including managing Task and Change Orders, expenses and tracking updates
Contributing to squads and acting as mediator
Performing full set of activities without assistance
Mentoring less experienced colleagues

Requirements

University degree or equivalent preferably in medical or biological science or discipline associated with clinical studies
At least 3+ years of relevant work experience in pharmaceutical or scientific environment
Knowledge of clinical trials and drug development process
Excellent knowledge of ICH-GCP and clinical study delivery process including regulations, operational best practices, industry standards
Familiarity with key systems used in clinical trial delivery
Experience in using Trial Master File industry accepted standard
Strong project management skills preferably with analytical and financial skills
Good leadership skills
Excellent verbal and written communication in English
Excellent communication and relationship building skills including external service provider management
Excellent knowledge of applicable clinical trial regulatory requirements such as Good Clinical Practice and International Conference on Harmonisation guidelines
Ability to manage multiple competing priorities within various clinical studies with good planning, time management and prioritization skills
Ability to think independently, analyse and solve problems systematically and creatively
Risk-based approach
Confirmed level of expertise and seniority within area and function
Logical and analytical thinking with inclination to spot patterns and outliers
Quality mindset, critical sense, attention to details
Effective training and mentoring skills
Very good understanding of principles of project planning and management
Knowledge of project finance and accounting principles to understand budget, invoices, cross-charges and expense reports
Excellent comprehension of Microsoft Office tools including Excel, PowerPoint, Word and Outlook
Knowledge of advanced Excel, timelines and budget tracking systems and clinical trial management systems
Excellent stakeholder management and communication skills oral and written
Outstanding interpersonal skills
Excellent networking capabilities and ability to influence and manage stakeholders at all levels
Ability to facilitate and lead cross-functional meetings
Ability to challenge status quo and inefficient ways of working
Comfortable in mediator role
Results driven and efficient
Motivated and dynamic personality
Ability to evolve in changing and challenging environment
Ability to coach study team members to focus on value, build business agility and embrace change
Ability to adjust to work in cross-functional squads in agile model
Team spirit and ability to work across cultures and geographies with high awareness and understanding of cultural differences

Company info

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.