Oncology Activation Manager

The mission of the Knight Cancer Clinical Research organization is to support the conduct of translational clinical research aimed at improving the lives of people and families with cancer by applying innovative strategies for cancer prevention screening diagnosis and treatment. The support is provided through proactive high quality and efficient study management in compliance with federal regulations and local policies and procedures. This fast-paced and intense research environment requires complex clinical research studies involving a very vulnerable and sick population.

Position Summary:

This position is responsible for oversight and improvement of activation of therapeutic interventional trials at OHSU Knight Cancer Clinical Research (KCCR). The successful candidate will identify bottlenecks implement measurable process improvements align stakeholders and build a culture of accountability and speed while maintaining compliance quality and patient safety. Their responsibilities include oversight of activation processes and stakeholders and development of SOPs and tools for streamlined trial activation. The Activation Manager will be responsible for tracking start-up metrics communicating with all start-up process owners and participants and implementation of efficiencies.

Success will be demonstrated through implementation of processes leading to significant and sustainable reduction in median trial activation timeline.

• Implement transparent enterprise-wide trial start-up dashboard.
• Standardize workflows across departments.
• Improve sponsor and investigator satisfaction.

This individual will work with research administration legal IRB finance compliance and clinical departments as well as investigators and sponsors/CROs to transform trial start-up performance and create a best-in-class activation model.

Duties & Responsibilities:

Strategic Leadership & Process Transformation

• Lead institutional initiatives to substantially decrease cycle time from protocol receipt to first patient enrollment.
• Facilitate the development and maintenance of centralized tracking systems and dashboards to monitor progress in real time.
• Proactively manage risks to timeline and ensure rapid issue resolution for delayed studies.
• Define and track clinical trial activation KPIs
• Map and evaluate current-state workflows across trial start-up functions.
• Establish standardized pathways for industry-sponsored investigator-initiated and cooperative group studies.
• Develop service-level agreements (SLAs) escalation pathways and accountability frameworks.
• Benchmark against peer institutions and industry best practices.
• Deliver regular leadership reports with recommendations.

Stakeholder Management

• Partner with investigators and department leaders to prioritize studies strategically.
• Collaborate with legal IRB contracting finance and compliance teams to remove structural barriers.
• Serve as institutional point person for sponsors/CROs regarding activation timelines and performance.

Change Management

• Lead organizational change efforts to improve urgency transparency and cross-functional collaboration.
• Train teams on new processes tools and expectations.
• Build a customer-service mindset focused on investigators patients and sponsors

Standardization across Disease Programs

• Collaborate with leadership to establish efficient and standard SOPs for all trial activation-related processes.
• Effectively document and communicate process improvement opportunities and products.
• Assess and resolve regulatory challenges that may delay study initiation and facilitate .
• Provide leadership of operations in trial activation activities ensuring appropriate support and training.

Personnel Management

• Identify recruit on-board and retain high-quality candidates.
• Collaborate with the Knight Trainer in training and retraining of staff members.
• Provide performance feedback to staff members on a regular basis.
• Conduct workload balancing and reassign studies as needed.
• Provide back-up coverage and support for study start-up activities when necessary.

Contributes to positive work environment and provides leadership in encouraging such an environment by personal example; maintains the highest ethical standards according to OHSU Policy including the Code of Conduct; maintains strict confidentiality of all sensitive confidential and/or proprietary documents and information.

OHSU classfication:

Oncology Clinical Research Manager 2

Education & Experience:

Bachelors and 7 years of relevant experience -or-

11 years of relevant experience

Relevant experience must include:

• At least 4 years of clinical research experience
• At least 1 year personnel management experience

Knowledge Skills & Abilities:

• Deep knowledge and experience with FDA ICH GCP and other regulatory guidelines that govern clinical research
• Strong understanding of clinical research requirements with regard to staffing systems and processes
• Ability to lead a group serve as a mentor and/or facilitator and create a positive work environment
• Ability to ensure and deliver a customer service orientation that translates into timely and reliable support to staff investigators sponsor partners and other customers
• Ability to set appropriate priorities and manage time
• Excellent communication skills; ability to express and document ideas clearly and concisely in written communications; able to champion personal perspective while maintaining the ability to listen comprehend and adjust when required to other points of view
• Self-starter with ability to work independently but collaboratively as part of a team
• Strong critical thinking skills problem-solving abilities organizational skills and multi-tasking capabilities
• Energy and drive to coordinate multiple projects simultaneously
• Solution-oriented approach to issues
• Ability to use tact and diplomacy to maintain effective working relationships
• Proficiency in Microsoft Office programs (Word Excel and PowerPoint)

Working conditions:

Primary working conditions in an office environment; will be required to work in the clinic area from time to time. Will be required to travel throughout the main institution which may be fair distances and to all Knight worksite locations including using the tram. Ability to travel to community sites in metropolitan Portland by car or by public transportation.

• Bachelors or Masters Degree
• One year Oncology Clinical Research Program Management
• Working knowledge of Access EPIC and/or Oracle
• Clinical research certification (SoCRA ACRP)

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