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Budapest, Central Hungary, Hungary · Remote Solely
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Full-time
bachelor degree
Posted 2d ago
~40 hrs/week
Remote in Budapest, Central Hungary, Hungary
Responsibilities
The specialist will facilitate site start-up activities, including essential document collection and review to ensure study timelines are met. They will also partner with internal teams and CROs to resolve activation delays and maintain accurate eTMF records.
Requirements
Candidates must hold a Bachelor's degree or international equivalent and possess at least 2 years of experience in clinical research site start-up. Proficiency in Microsoft Office and a strong understanding of FDA and ICH-GCP guidelines are required.
Full job description
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
OBJECTIVES/PURPOSE
Supporting the facilitation of site start up and communication with internal and external team members to ensure prompt site approval and study timelines are achieved.
Support sites and study teams to achieve rapid site start up.
ACCOUNTABILITIES
Work directly with assigned sites on all site related essential document collection and review.
Partner with internal Study Startup team, CROs, Clinical Operations teams, and TAU partners to improve overall SSU metrics and deliver processes.
Ensure standards are applied to the SSU processes across projects.
Review site essential documents for start up including but not limited to: ICF, FDF, 1572, CVs etc
Promptly recognize and improve potential site activation delays and escalate to appropriate team members.
Track all actions and communications with sites to ensure timelines are achieved for studies and sites assigned.
Support resolving escalated issues identified by the CROs and Clinical Operations teams in partnership with the internal Study Startup team.
Review and provide feedback to management on site performance metrics.
Ensure accuracy and completeness of the eTMF for assigned sites during start up
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise(Breadth and depth of knowledge, application and complexity of technical knowledge)
Understanding of the pharmaceutical industry (e.g., clinical development, the prescription drug distribution process, etc.)
Understanding of Clinical Trial Agreements, budgeting and fair market value principals
Knowledge or FDA and ICH-GCP guidelines for conducting clinical research
Leadership(Vision, strategy and business alignment, people management, communication, influencing others, managing change)
Demonstrated ability to work across functions, regions and cultures
The ability to inspire, motivate and drive results
Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing
Proven skills as an effective team player who can engender credibility and confidence within and outside the company
Ability to distil complex issues and ideas down to simple comprehensible terms
Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization
Decision-making and Autonomy(The capacity and authority to make organizational decisions, autonomy in decision-making, complexity of decisions, impact of decisions, problem-solving)
Broad decision-making responsibilities:
Ability to make decisions
Accountable for decision making for designated tasks
Ability to seek diverse input from multiple constituents and stakeholders to drive innovative solutions
Ability to incorporate feedback and ensure decisions are made swiftly to yield flawless execution
Interaction(The span and nature of one’s engagement with others when performing one’s job, internal and external relationships)
Effectively navigates the changing external and internal environment
Effectively represent Takeda in High-level negotiations with the ability to resolve conflict in a constructive manner
Takes the initiative and proactively resolves challenges with internal and external team members.
Complexity(Products managed, mix of businesses, internal and/or external business environment, cultural considerations)
Ability to work in a global ecosystem (internal and external) with a high degree of complexity
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
BS degree or international equivalent
2 or more years of experience in clinical research Site Start Up within a pharmaceutical company, CRO or relevant industry vendor.
Ability to explain data to facilitate decision making processes to be data driven.
Knowledge and understanding of clinical study protocols and essential documents
Strong organizational skills, decision making, communication and negotiation skills
Proficient in Microsoft Excel, Word, and PowerPoint.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $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.
For more information, please visit www.thermofisher.com.
Offices: 168 Third Avenue, Waltham, MA, US
Analytical InstrumentsLaboratory Supply Chain Programs and eCommerceLaboratory EquipmentLab ServicesSpecialty DiagnosticsLife SciencesPharma Servicesand CDMOElectronicsHealth Care
How many Healthcare jobs are open in Budapest, Hungary right now?
There are currently 406 open healthcare positions in Budapest, Hungary listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Healthcare roles in Budapest, Hungary?
Companies currently hiring include Gedeon Richter, Roche, Sanofi, Servier Pharmaceuticals, Opella, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Healthcare jobs in Budapest, Hungary?
Yes — 235 of the 406 open healthcare positions offer remote or hybrid work (27 remote, 208 hybrid).
How do I apply for Healthcare jobs in Budapest, Hungary?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.