Clinical Research Manager
Clinical Research Manager
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Salary Not Disclosed
1 Vacancy
Job Description
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
At Thermo Fisher Scientific youll 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 Information
Our Early Development team focuses on Phase I and IB trials which represent the first practical tests of a compounds 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 compounds efficacy safety and positive impact on patients 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:
Education
Bachelors degree or equivalent and relevant formal academic / vocational qualification
Experience
- 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
Required Experience:
Manager
Employment Type
Full-Time
