Clinical Research Manager

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Trvalý pracovní poměr
Plný úvazek

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Work Schedule Standard (Mon-Fri)Environmental Conditions OfficeJob DescriptionAt Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.Location/Division Specific InformationOur Early Development team focuses on Phase I and IB trials which represent the first practical tests of a compound’s clinical relevance and commercial viability. They are the culmination of years or even decades of research. Moreover, they set the stage for subsequent studies that will ultimately determine your compound’s efficacy, safety and positive impact on patient’s lives.Discover Impactful Work:Manages all aspects of assigned clinical trials involving patient and healthy subject populations in both inpatient and outpatient settings. Acts as liaison between functions (i.e. PM, investigator, research team, etc.) Ensures client requirements and specifications are communicated to the research teams and any issues/questions raised by the research team or investigators are communicated back to the project leads and client (as needed) for resolution.A day in the Life:

Serves as a primary point of contact for the project team and the business unit for clinical site related aspects of the study.
Collaborates with internal departments to ensure deliverables are met as defined within the contract and study timeline.
Manages all clinical and administrative aspects of a clinical project, including site level study set-up, recruitment, conduction and data collection.
Manages IRB submissions including creation of study specific informed consent forms, SAE notifications and maintenance of the regulatory file and documents.
Collects feedback from various departments to create a risk register for each study and maintains and updates the register throughout the study. Works with the Principal Investigator to ensure that a risk mitigation plan (RMP) is finalized and reviewed by the safety committee prior to study conduct.
Works closely with finance department to manage fiscal aspects of study conduct while meeting sponsor requirements and adhering to the protocol, SOPs and contract.
Provides vendor oversight when services are contracted.

Keys to Success:EducationBachelor's degree or equivalent and relevant formal academic / vocational qualificationExperience

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills, Abilities

Knowledge of Phase I processes and strong knowledge of clinical study operations
Knowledge of FDA regulations and ICH GCP guidelines
Solid computer skills with working knowledge of Microsoft Office applications
Good time management and multi-tasking skills
Solid written and verbal communication skills
Strong organizational and prioritization skills with the ability to prioritize workload and adapt to changing study needs
Favorable consulting skills with t to act as a liaison between external and internal groups
Knowledge of budgeting/forecasting/planning projects
Excellent communication skills with Czech and English

Thermo Fisher Scientific

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