[Remote] Clinical Trial Manager (Remote, East Coast ONLY)
Note: The job is a remote job and is open to candidates in USA. Blue Earth Diagnostics is an established molecular imaging company focused on providing innovative diagnostics solutions in cancer. The Clinical Trial Manager will manage all aspects of clinical trial activities, ensuring compliance with regulations and efficient execution of trials within budget and timeline constraints. Responsibilities • In accordance with BED SOPs: plan, implement, monitor and report on progress against project plans and revise/update as necessary throughout the lifetime of the study • Lead the combined study team ensuring effective cross-functional teamwork, while managing trial timelines, budgets, resources, vendors and strategy • Work directly with internal teams and external partners to create and proactively manage trial timelines, budgets, resources, vendors and strategy • Maintains tracking and provides reports on clinical trial progress against timelines and budget. Monitor trial assumptions, schedule and costs to ensure all remain on track with the executed contract(s) • Act as the primary contact point with CROs, clinical sites and vendors for assigned trial(s) • Understand the trial delivery strategy, costing assumptions and resulting budget for assigned trial(s) in order to manage vendors • Ensure that a robust risk mitigation strategy is in-place, regularly monitored for each study, and any issues are escalated as needed to appropriate stakeholders • Track and forecast changes in SOW and associated budget including forecasting annual and 5 years planning /spend • Other duties as determined by business needs Skills • Must have a life science or nursing degree or a similar qualification • Must have at least 3 years of previous trial management experience at trial management level on international clinical trials in pharmaceutical and/or CRO industries • Excellent decision-making, facilitation, communication and organizational skills • Ability to work collaboratively on multi-disciplinary project teams and proactively manage relationships with external vendors • Must be able to understand, interpret, and explain protocol requirements to others in a clear and concise manner • Must have prior monitoring experience as co-monitoring may be required • Experience and skilled with cross-functional and highly matrixed organizations • Demonstrated ability to handle multiple competing priorities, utilize resources effectively and adapt flexibly to changing priorities • Effective computer skills with good working knowledge of a range of computer programs • Team player • Oncology clinical trial experience desirable • Experience with Radiopharmaceutical clinical trial management highly desirable but not mandatory • Knowledge of ICH GCP, international regulatory requirements & guidelines for the conduct of clinical development programs is also a bonus Benefits • Complete healthcare plan • 401k with matching • Generous paid holidays • Work/life harmony Company Overview • Blue Earth Diagnostics is an established molecular imaging company focused on providing innovative, well-differentiated diagnostics solutions, informing patient management, and driving future therapies in cancer. It was founded in 2014, and is headquartered in Monroe Township, New Jersey, US, with a workforce of 51-200 employees. Its website is Apply tot his job