Kelly Science, Engineering, Technology & Telecom · 1 day ago
Study Manager - Oncology
United States
Full-time
Remote
Entry, Mid Level
2+ years expKelly Science, Engineering, Technology & Telecom is seeking a Study Manager specializing in Oncology to drive the progression of clinical trials in compliance with regulatory requirements. The role involves operational planning, team leadership, risk management, stakeholder collaboration, and ensuring regulatory compliance throughout the study lifecycle.
Staffing & Recruiting
Hiring Manager
Lea Lolley
Responsibilities
Accountable for the end-to-end performance of assigned protocols. This includes proactive planning, driving, and tracking deliverables, timelines, and results from study startup through closeout
May serve as the Clinical Trial Team (CTT) lead or coordinate local study teams (including CRAs and other local roles), ensuring strong collaboration and high performance
Leads the team in timeline management, risk identification and mitigation, and issue resolution throughout the study lifecycle
Facilitates and collaborates with key internal and external stakeholders, such as the study team, country teams, functional vendors, and investigators/sites, to support study objectives
Ensures study execution is in compliance with ICH/GCP (Good Clinical Practice) and country-specific regulations, company policies, and quality standards
Leads team efforts on key study elements, including:
Data management deliverables
Trial-level plans and timelines
Country/site selection
Investigator meeting planning
Communication plans
Study close-out activities
Manages any study-specific partners and/or vendors
Qualification
Required
Bachelor's degree (preferably in life sciences or a comparable scientific discipline)
2+ years of experience in pharmaceutical, clinical drug development, project management, and/or a medical field
Previous experience in Oncology is required
Solid knowledge of clinical research regulatory requirements, including GCP and ICH guidelines
Strong understanding and application of the principles of project planning and project management, including analytical skills for driving operational milestones
Ability to apply leadership skills in a matrix environment, proactively driving toward study goals and influencing peers, internal/external customers, and vendors
Excellent problem-solving, prioritization, conflict resolution, and critical thinking skills
Strong written and verbal communication, negotiation, and presentation skills
Company
Kelly Science, Engineering, Technology & Telecom
Kelly Science, Engineering, Technology & Telecom specializes in science, engineering, technology, and telecom.
5001-10000 employees
Funding
Current Stage
Late StageLeadership Team
Linda Stuit
Senior Vice President, Engineering Specialty
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