DotLab is hiring a Clinical Trial Manager who will support DotLab 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.

Responsibilities:

• Manage all operational aspects of DotLab clinical trials from start-up through enrollment, maintenance, and close-out
• Develop and review 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
• Contribute to case report form design, EDC user acceptance testing, and other data management related activities
• 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
• Contribute to the development and management of site or other study-related budgets and ensure invoice payment according to site payment terms
• Work cross functionally with other departments such as R&D, Commercial/Marketing and Finance on all aspects of the clinical trial
• Participate in or lead internal and external study meetings
• Perform on-site or remote site monitoring visits, as needed
• Participate in vendor selection and provide oversight of monitors, vendors or contract research organizations (CRO), as applicable
• Establish and maintain strong relationships and communication with sites and site staff
• Ensure Trial Master File (TMF) is current and maintained
• Provide guidance and mentorship to junior team members

Requirements:

• A Bachelor’s degree or equivalent in the life sciences or related field required.
• 5+ 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
• 2+ years of study monitoring (CRA) experience is strongly desired
• Industry experience within in vitro diagnostics (IVD) highly preferred; biologics or medical device experience also acceptable
• Women’s health and previous start-up 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
• Additional coursework or certifications in clinical trial planning and management is desired
• 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