Study Manager - Oncology

Kelly Science, Engineering, Technology & Telecom; United States; On-site; USD 90,000 - 130,000; Full time

Job summary

Kelly Science, Engineering, Technology & Telecom is seeking a Study Manager to drive oncology trial progression, ensuring regulatory compliance and high performance across teams. The role emphasizes end-to-end study planning, risk mitigation, and stakeholder collaboration to meet study objectives.

Responsibilities include leading trial deliverables, coordinating local study teams, and maintaining adherence to GCP and ICH guidelines throughout the study lifecycle.

Qualifications

• Bachelor's degree in life sciences or comparable discipline.
• 2+ years of experience in pharmaceutical, clinical drug development, project management, or medical field.
• Oncology experience required.
• Solid knowledge of clinical research regulatory requirements, including GCP and ICH guidelines.

Responsibilities

• Own end-to-end performance of assigned trial protocols from startup through closeout.
• 可能 lead Clinical Trial Team (CTT) or coordinate local study teams, ensuring collaboration and high performance.
• Lead timeline management, risk identification and mitigation, and issue resolution across the study lifecycle.
• Collaborate with internal and external stakeholders (study team, country teams, vendors, investigators/sites) to support study objectives.
• Ensure study execution complies with ICH/GCP and country regulations, quality standards.
• Lead deliverables: trial plans, country/site selection, communication plans, and close-out activities.
• Manage study-specific partners and vendors.

Skills

Project management

Communication

Leadership

Risk management

Stakeholder collaboration

Quality assurance

GCP/ICH knowledge

Education

Bachelor's degree in life sciences or related field

Job description

The Study Manager applies project management, communication, and leadership skills to drive the trial's progression in compliance with all regulatory requirements.

The main duties focus on the successful and compliant execution of the clinical trial protocol:

• Operational Planning and Execution: 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.
• Team Leadership & Coordination: 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.
• Risk and Issue Management: Leads the team in timeline management, risk identification and mitigation, and issue resolution throughout the study lifecycle.
• Stakeholder Collaboration: 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.
• Regulatory Compliance and Quality: Ensures study execution is in compliance with ICH/GCP (Good Clinical Practice) and country-specific regulations, company policies, and quality standards.
• Study Deliverables: Leads team efforts on key study elements, including:
• Trial-level plans and timelines.
• Country/site selection.
• Communication plans.
• Study close-out activities.
• Vendor and Partner Management: Manages any study-specific partners and/or vendors.

Education and Experience:

• Required Education: Bachelor's degree (preferably in life sciences or a comparable scientific discipline).
• Required Experience:
• 2+ years of experience in pharmaceutical, clinical drug development, project management, and/or a medical field
• Previous experience in Oncology is required

Key Skills:

• Clinical Research Knowledge: Solid knowledge of clinical research regulatory requirements, including GCP and ICH guidelines.
• Project Management: Strong understanding and application of the principles of project planning and project management, including analytical skills for driving operational milestones.
• Leadership and Influence: Ability to apply leadership skills in a matrix environment, proactively driving toward study goals and influencing peers, internal/external customers, and vendors.
• Problem-Solving: Excellent problem-solving, prioritization, conflict resolution, and critical thinking skills.
• Communication: Strong written and verbal communication, negotiation, and presentation skills.