[Hiring] Clinical Trial Manager @DotLab

Role Description

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
• 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
• Be proactive in seeking and utilizing available resources to effectively problem solve
• Be flexible and creative while ensuring compliance with regulatory quality requirements
• Identify areas of improvement to drive efficiency within Clinical Operations

Responsibilities include:

• 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

Qualifications

• 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