Clinical Research Manager at PPD in Austin, TX
Summarized Purpose:
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.
Essential Functions:
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.
Salary Range:
$80K -- $100K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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.
Essential Functions:
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.
Salary Range:
$80K -- $100K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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