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Position Summary:
Mirvie is hiring a Clinical Trial Manager who will support ongoing clinical trials and be a key member of the Clinical Operations team. This will include supporting day-to-day execution of a clinical trial, building strong internal and external relationships, managing clinical sites, and collaborating with cross functional teams.
Mirvie is hiring a Clinical Trial Manager who will support ongoing clinical trials and be a key member of the Clinical Operations team. This will include supporting day-to-day execution of a clinical trial, building strong internal and external relationships, managing clinical sites, and collaborating with cross functional teams.
This position will require experience working in a fast-paced environment. The candidate will have the ability to work in ambiguity, to be proactive in seeking and utilizing available resources to effectively problem solve, to be flexible and creative while ensuring the clinical trials are executed in compliance with regulatory quality requirements, and identifying areas of improvement to drive efficiency within Clinical Operations.
Roles and Responsibilities:
Manage operational aspects of Mirvie clinical trials from start-up through enrollment, maintenance, and close-out
Assist with development of study-related plans and documents including protocols, informed consent forms, recruitment plans, monitoring plans, protocol deviation plans, case report forms, and site training and engagement materials with minimal supervision
Effectively communicate and collaborate with external partners
Participate in identifying, selecting, and monitoring the performance of clinical sites
Ensure proper site training and management, provide ongoing oversight of clinical site compliance with study plans, study protocol, SOPs, ICH/GCP guidelines, and in accordance with all applicable regulations
Participate in data management related activities such as working with sites to stay on top of data entry and query resolution
Develop study dashboards and metrics, continuously identify potential risks to the study timelines and/or conduct, and propose and implement mitigations with cross-functional team and manager support
Review and track site and vendor study invoices
Participate in internal and external study meetings
Provide support with oversight of monitors, vendors or contract research organizations (CRO), as applicable
Ensure Trial Master File (TMF) is current and maintained
Provide guidance and mentorship to junior team members
Qualifications and Experience:
A Bachelor’s degree is required
3+ years of relevant experience in managing clinical trials in either sponsor or CRO organizations, with a strong track record of successful trial initiation and execution
Industry experience within in vitro diagnostics (IVD) highly preferred; biologics or medical device experience also acceptable
Previous start-up company experience is preferred
Thorough knowledge of GCP, ICH guidelines and other clinical regulatory requirements
Working experience with an electronic data capture (EDC) system and eTMF system
Strong interpersonal communication (written and verbal), organizational and prioritization skills
Ability to work independently and effectively under a fast-paced and changing environment
Strong work ethic and demonstrated ability to deliver assignments on time
Proficient with office automation tools, such as the Google suite of apps and Microsoft Office
