Oncology Clinical Trial Operations Manager

Location:

Avera Cancer Institute-Sioux Falls

Worker Type:

Regular

Work Shift:

Primarily days with possible weekends/evenings/holidays (United States of America)

Position Highlights:

You Belong at Avera

Be part of a multidisciplinary team built with compassion and the goal of Moving Health Forward for you and our patients. Work where you matter.

A Brief Overview

Implements the oncology research vision by leading the administrative and operational infrastructure required to activate, maintain, and support clinical trials. This manager translates portfolio strategy into coordinated study start-up, regulatory, financial, and data-service workflows; aligns resources with organizational priorities; and drives execution of activation, contracting, regulatory, data-entry, and query-resolution expectations. The role leads initiatives, monitors operational performance, and ensures accountability for timely and compliant trial support.

What you will do

• Collaborates with leadership to implement the oncology research vision, shape department priorities, and translate strategy into operational plans for the operations teams.
• Oversees operations for the Research Assistant, Study Start-up, Clinical Trial Analyst, and Regulatory teams; directs team efforts, delegates and prioritizes work, and ensures consistent execution across the clinical trial lifecycle.
• Aligns staffing, workload, and resources with the study portfolio and organizational priorities to meet study start-up, contract and budget, regulatory, data-entry, query-resolution, and department deadlines.
• Operationalizes the end-to-end study activation process, including review and coordination of schedules of events, routine-care versus research-only requirements, contract language, regulatory submissions, and other study start-up activities.
• Oversees regulatory submission, maintenance, and documentation workflows and coordinates with sponsors, CROs, investigators, clinical teams, pharmacy, legal, compliance, and other Avera departments to resolve operational barriers.
• Oversees Research Assistant workflows supporting data entry, query resolution, research documentation, and laboratory specimen coordination and ensures staff have clear priorities, training, and accountability for timely, accurate work.
• Leads departmental initiatives related to clinical trial systems; makes recommendations for electronic applications, coordinates upgrades and validation, and manages software-vendor liaison activities.
• Establishes and monitors performance metrics for activation cycle time, contract and budget execution, regulatory timeliness, data-entry timeliness, query aging, workload, and staff productivity; uses results to drive process improvement and accountability.
• Participates in operational budget planning, workforce planning, and resource decisions and recommends investments needed to achieve enrollment and department goals.
• Responsibilities include interviewing, hiring, developing, training, and retaining employees; planning, assigning, and leading work; appraising performance; rewarding and coaching employees; addressing complaints and resolving problems.

Essential Qualifications

The individual must be able to work the hours specified. To perform this job successfully, an individual must be able to perform each essential job function satisfactorily including having visual acuity adequate to perform position duties and the ability to communicate effectively with others, hear, understand and distinguish speech and other sounds. These requirements and those listed above are representative of the knowledge, skills, and abilities required to perform the essential job functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential job functions, as long as the accommodations do not cause undue hardship to the employer.

Required Education, License/Certification, or Work Experience:

• Bachelor's
• ACRP Certified Professional (ACRP-CP) - Association of Clinical Research Professionals (ACRP) Upon Hire or
• Certified Clinical Research Professional (CCRP) - Society of Clinical Research Associates (SOCRA) Upon Hire

Preferred Education, License/Certification, or Work Experience:

• Related research experience and/or training
• Clinical experience

Expectations and Standards

• Commitment to the daily application of Avera’s mission, vision, core values, and social principles to serve patients, their families, and our community.
• Promote Avera’s values of compassion, hospitality, and stewardship.
• Uphold Avera’s standards of Communication, Attitude, Responsiveness, and Engagement (CARE) with enthusiasm and sincerity.
• Maintain confidentiality.
• Work effectively in a team environment, coordinating work flow with other team members and ensuring a productive and efficient environment.
• Comply with safety principles, laws, regulations, and standards associated with, but not limited to, CMS, The Joint Commission, DHHS, and OSHA if applicable.

Benefits You Need & Then Some:

Avera is proud to offer a wide range of benefits to qualifying part-time and full-time employees. We support you with opportunities to help live balanced, healthy lives. Benefits are designed to meet needs of today and into the future.

• PTO available day 1 for eligible hires.

• Up to 5% employer matching contribution for retirement

• Career development guided by hands-on training and mentorship

Avera is an Equal Opportunity Employer - Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, Veteran Status, or other categories protected by law. If you are an individual with a disability and would like to request an accommodation for help with your online application, please call 1-605-504-4444 or send an email to [email protected].

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