Clinical Research Manager

Thermo Fisher Scientific • Austin, TX

2d

About The Position

The Clinical Research Manager manages all aspects of assigned clinical trials involving patient and healthy subject populations in both inpatient and outpatient settings. The role involves acting as liaison between functions (i.e. PM, investigator, research team, etc.) The Clinical Research Manager 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. What You'll Do: Serve as a primary point of contact for the project team and the business unit for clinical site related aspects of the study. Collaborate with internal departments to ensure deliverables are met as defined within the contract and study timeline. Manage all clinical and administrative aspects of a clinical project, including site level study set-up, recruitment, conduction and data collection. Manage IRB submissions including creation of study specific informed consent forms, SAE notifications and maintenance of the regulatory file and documents. Collect feedback from various departments to create a risk register for each study and maintains and updates the register throughout the study. Work with the Principal Investigator to ensure that a risk mitigation plan (RMP) is finalized and reviewed by the safety committee prior to study conduct. Work closely with finance department to manage fiscal aspects of study conduct while meeting sponsor requirements and adhering to the protocol, SOPs and contract. Provide vendor oversight when services are contracted.

Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years). Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.
• 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.

Responsibilities

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

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees