Manager, Study Operations

OneOncology is positioning community oncologists to drive the future of cancer care through a patient-centric, physician-driven, and technology-powered model to help improve the lives of everyone living with cancer. Our team is bringing together leaders to the market place to help drive OneOncology’s mission and vision.

Why join us? This is an exciting time to join OneOncology. Our values-driven culture reflects our startup enthusiasm supported by industry leaders in oncology, technology, and finance. We are looking for talented and highly-motivated individuals who demonstrate a natural desire to improve and build new processes that support the meaningful work of community oncologists and the patients they serve.

Job Description:

The Manager, Study Operations is responsible for overseeing the successful execution of clinical trials in the oncology therapeutic area. This role involves strategic planning, cross-functional team leadership, and operational management to ensure that clinical studies are conducted on time, within budget, and in compliance with regulatory standards. This role will focus heavily on accrual support initiatives to drive enrollment across network practices. The Manager, Study Operations will also play a critical role in mentoring and developing clinical operations teams, fostering a culture of excellence and continuous improvement.

Responsibilities

• Develop and drive the implementation of long-term strategies for the oncology study portfolio, identifying opportunities for innovation and efficiency.
• Drive accrual support initiatives across network practices.
• Develop and implement operational plans for clinical trials from activation through closeout.
• Manage study timelines, budgets, and resources to ensure achievement of study objectives.
• Lead and mentor a team overseeing the clinical trial life cycle.
• Provide leadership and oversight to ensure that vendors and sites meet performance expectations and adhere to study protocols.
• Foster a collaborative and high-performance culture within the team, encouraging professional development and continuous learning.
• Ensure seamless communication and collaboration across all stakeholders, facilitating the effective integration of cross-functional insights into study planning and execution.
• Provide regular updates to senior management on study progress, risks, and issues.
• Identify potential risks to study timelines, budget, or quality, and develop mitigation strategies in collaboration with cross-functional teams.
• Lead change initiatives within the clinical operations function, driving the adoption of new processes, technologies, and best practices.
• Contribute to the development and refinement of clinical study tools, templates, and procedures.
• Stay current with industry trends and best practices, integrating new insights into the organization’s clinical operations strategies.
• Champion the adoption of new technologies and methodologies in oncology study operations.
• Drive the implementation of innovative solutions that enhance the effectiveness of clinical trials and improve patient outcomes.
• Other duties as assigned to help drive our mission of improving the lives of everyone living with cancer.
  
  

Key Competencies

• Strong understanding of clinical trial processes
• Strong leadership and team management skills
• Excellent organizational and project management abilities
• In-depth knowledge of GCP, ICH guidelines, and regulatory requirements
• Effective communication and interpersonal skills, with the ability to collaborate across multidisciplinary teams
• Ability to work independently and collaboratively in a fast-paced environment
  
  

Qualifications

• Bachelor's or advanced degree in a relevant field (e.g., life sciences, pharmacy, nursing) preferred
• Minimum of 7-10 years of experience in clinical research management, with at least 2 years managing a team
• Experience working with CROs, sponsors, and study sites
• Proficiency in Microsoft Office applications and familiarity with electronic regulatory binder systems and clinical trial management systems (CTMS) preferred.
• Certification in clinical research (e.g., SoCRA, ACRP) is a plus.
  
  

This job description does not contain a full listing of activities, duties or responsibilities required of this role. Duties, responsibilities and activities may change, or new ones may be assigned at any time with or without notice.