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Blue Earth Diagnostics, Inc. (U.S.) · 2 hours ago

Clinical Trial Manager (Remote, East Coast ONLY)

United States

Full-time

Remote

Mid Level

$120K/yr - $135K/yr

3+ years exp

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.

Pharmaceuticals

Hiring Manager

Michaela Benemar

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

Qualification

Clinical Trial ManagementOncology ExperienceRadiopharmaceutical ManagementICH GCP KnowledgeMonitoring ExperienceComputer SkillsDecision-Making SkillsCommunication SkillsOrganizational SkillsTeam Player

Required

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

Preferred

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

Blue Earth Diagnostics, Inc. (U.S.)

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.

Founded in 2014

Monroe Township, New Jersey, US

51-200 employees