Oncology Clinical Trial Operations Manager

Avera; Sioux Falls (SD); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

PTO from day 1

5% retirement match

Career development and mentorship

Job summary

Avera Cancer Institute-Sioux Falls is seeking an Oncology Research Manager to lead the administrative and operational infrastructure for clinical trials. You will translate portfolio strategy into study start-up workflows, allocate resources, and drive activation, contracting, regulatory, data-entry, and query-resolution processes.

You'll supervise Research Assistant, Study Start-up, Clinical Trial Analyst, and Regulatory teams; monitor performance metrics; and partner with sponsors, CROs,

Qualifications

• Bachelor's degree required.
• ACRP Certified Professional (ACRP-CP) or CCRP required on hire.
• Experience with regulatory processes in clinical research preferred.

Responsibilities

• Collaborate with leadership to implement oncology research vision and translate strategy into operational plans for the teams.
• Oversee operations for Research Assistant, Study Start-up, Clinical Trial Analyst, and Regulatory teams; ensure consistent execution across the lifecycle.
• Align staffing and resources with study portfolio to meet start-up, contract, budget, regulatory, data-entry, and query-resolution deadlines.
• Operationalize end-to-end study activation including regulatory submissions and contract language.
• Oversee regulatory submission, maintenance, and documentation workflows and coordinate with sponsors, CROs, investigators, and other departments.
• Lead workflows supporting data entry, query resolution, and research documentation; ensure staff have priorities and training.
• Drive initiatives related to clinical trial systems, vendor liaison, upgrades and validation of software.

Skills

Leadership

Regulatory knowledge

Process improvement

Cross-functional collaboration

Education

Bachelor's

ACRP Certified Professional (ACRP-CP)

Certified Clinical Research Professional (CCRP)

Job description

Sioux Falls, SD

Full time

R-260031072

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

Online Privacy Policy:

At Avera, we are committed to protecting your online privacy. For more information, please visit https://www.avera.org/legal-notices/online-privacy-policy/

At Avera, we are committed to protecting your online privacy. For more information, please visit https://www.avera.org/legal-notices/online-privacy-policy/

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 [e-mail].

At Avera , the way you are treated as an employee translates into the compassionate care you deliver to patients and team members. Because we consider health care a ministry, you can live out your faith, uphold the dignity and respect of all persons while not compromising high-quality services. Join us in making a positive impact on moving health forward.

At Avera , we are committed to protecting your online privacy. For more information, please visit https://www.avera.org/legal-notices/online-privacy-policy/

The policy of Avera to provide opportunities for all qualified employees or applicants without regard to disability and to provide reasonable accommodations for all employees or applicants who may be disabled. Avera is committed to ensuring compliance in accordance with the Americans with Disability Act. For assistance, please contact HR Now at 605-504-4444.

Additional Notices:

For TTY, dial 711

Avera is an Equal Opportunity/Affirmative Action Employer: Minority/Female/Disabled/Veteran/Sexual Orientation/Gender Identity.