Oncology Clinical Trial Operations Manager

Avera•Sioux Falls, SD

20h•Onsite

About The Position

The Oncology Clinical Trial Operations Manager implements the oncology research vision by leading the administrative and operational infrastructure needed to activate, maintain, and support clinical trials. The manager translates portfolio strategy into coordinated study start-up, regulatory, financial, and data-service workflows, aligns resources with organizational priorities, and drives timely, compliant trial support. The role oversees the Research Assistant, Study Start-up, Clinical Trial Analyst, and Regulatory teams, leads operational initiatives, monitors performance, and ensures accountability across the clinical trial lifecycle. The manager collaborates with leadership to set priorities and operational plans; coordinates study activation, contracts and budgets, regulatory submissions, data entry, and query resolution; and works with sponsors, CROs, investigators, clinical teams, pharmacy, legal, compliance, and other departments to resolve barriers. The position also supports workforce and budget planning, manages clinical-trial systems initiatives, and supervises staff through hiring, training, performance management, coaching, and retention. This is a regular position based at Avera Cancer Institute in Sioux Falls. The work shift is primarily days, with possible weekends, evenings, and holidays. A bachelor's degree and an ACRP-CP or CCRP certification are required upon hire. Related research experience or training and clinical experience are preferred.

Requirements

Bachelor's degree.
ACRP Certified Professional (ACRP-CP) certification from the Association of Clinical Research Professionals (ACRP), upon hire, or Certified Clinical Research Professional (CCRP) certification from the Society of Clinical Research Associates (SOCRA), upon hire.
Ability to perform the essential job functions satisfactorily, including adequate visual acuity for position duties and the ability to communicate effectively, hear, understand, and distinguish speech and other sounds.
Ability to work the hours specified.
Ability to maintain confidentiality, work effectively in a team environment, coordinate workflow, and comply with applicable safety principles, laws, regulations, and standards.

Nice To Haves

Related research experience and/or training.
Clinical experience.

Responsibilities

Collaborate with leadership to implement the oncology research vision, shape department priorities, and translate strategy into operational plans.
Oversee the Research Assistant, Study Start-up, Clinical Trial Analyst, and Regulatory teams; delegate and prioritize work and ensure consistent execution across the clinical trial lifecycle.
Align 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.
Coordinate end-to-end study activation, including schedules of events, routine-care versus research-only requirements, contract language, regulatory submissions, and other start-up activities.
Oversee regulatory submission, maintenance, and documentation workflows and coordinate with sponsors, CROs, investigators, clinical teams, pharmacy, legal, compliance, and other departments to resolve operational barriers.
Oversee Research Assistant workflows for data entry, query resolution, research documentation, and laboratory specimen coordination; ensure staff have clear priorities, training, and accountability.
Lead initiatives related to clinical trial systems; recommend electronic applications, coordinate upgrades and validation, and manage software-vendor liaison activities.
Establish and monitor performance metrics for activation cycle time, contract and budget execution, regulatory timeliness, data-entry timeliness, query aging, workload, and staff productivity; use results to drive process improvement and accountability.
Participate in operational budget planning, workforce planning, and resource decisions, and recommend investments needed to achieve enrollment and department goals.
Interview, hire, develop, train, and retain employees; plan, assign, and lead work; appraise performance; reward and coach employees; address complaints; and resolve problems.
Apply Avera's mission, vision, core values, and social principles; promote compassion, hospitality, and stewardship; uphold CARE standards; maintain confidentiality; coordinate effectively with team members; and comply with applicable safety principles, laws, regulations, and standards.