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Clinical Operations Supervisor / Madison, Wi (On-Site)

3+ years
Not Disclosed
10 Nov. 11, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Clinical Operations Supervisor – Madison, WI (On-Site)

Location: Madison, WI
Category: Clinical
Job ID: 254681
Work Type: Full-time, Office/Clinic-Based


About the Organization

A global leader in Clinical Research with Early Phase Units across the UK and US.
This role supports Phase I trials, including ascending dose, first-in-human, food effect, and drug–drug interaction studies.


Role Overview

The Clinical Operations Supervisor oversees clinical operations staff, ensures protocol compliance, and maintains high-quality standards in Phase I clinical trials.

You will interact directly with healthy volunteers, work with multidisciplinary teams, and contribute to early drug development including safety, tolerability, and PK profiling.


Key Responsibilities

Leadership & Staff Management

  • Supervise RNs, LPN/LVNs, and Research Technicians.

  • Lead by example, promote problem-solving, and maintain team productivity.

  • Conduct interviewing, hiring, training, coaching, disciplining, and staff development.

  • Ensure adequate staffing levels to meet workload demands.

  • Oversee scheduling for staff and investigators.

Quality, Compliance & Protocol Adherence

  • Maintain strict adherence to ICH/GCP, SOPs, and study protocols.

  • Ensure participant safety, welfare, and dignity at all times.

  • Implement and support Quality initiatives in assigned areas.

  • Ensure accurate, complete, and compliant data records.

  • Respond promptly to QA findings and correct deficiencies.

Training Oversight

  • Ensure staff have required training and competency documentation.

  • Maintain complete and current training files in alignment with SOPs and ICH/GCP.

  • Update or create relevant SOPs and Policies/Procedures.

Operational Responsibilities

  • Support protocol coordination activities.

  • Assist in planning study setup.

  • Ensure high-quality CRF output that meets sponsor expectations.

  • Comply with all departmental meetings and reporting requirements.

  • Track & evaluate monthly KPIs across departments.

  • Support continuous improvement and implement best practices.

  • Assist with study procedures (e.g., cannulation, telemetry, vitals, ECGs, venipuncture).

Administrative & Budget Responsibilities

  • Maintain communication with management on operational status.

  • Contribute to meeting budgeted performance goals.


Required Qualifications

Education & Experience

Option A (Preferred):

  • BS in science/medical field

  • 3+ years related experience, including 1–2 years research experience

Option B (Alternative):

  • LPN, LVN, or Associate Degree (AD)

  • 5–7 years related experience, including 1–2 years research experience

Additional experience may substitute for formal education.


Skills & Competencies

  • Strong knowledge of ICH/GCP standards

  • Excellent leadership, communication, and interpersonal skills

  • Ability to work under strict time constraints

  • Comfort with technology & electronic data capture systems

  • Excellent English (written & oral)

  • Ability to multitask and adapt to changing priorities


Work Environment Expectations

Comfortable working in an environment that is:

  • Fast-paced with zero protocol deviations

  • Dynamic with constant priority shifts

  • Highly collaborative requiring strong teamwork

  • Technology-driven, using electronic data collection systems


Physical Requirements

  • Stand or remain stationary 6–8 hours/day

  • Finger/hand movement for keyboard/equipment use up to 6 hours/day

  • Occasional crouching/stooping; frequent bending/twisting

  • Lift/carry 15–20 lbs (e.g., luggage, laptop)

  • Use various in-house/off-the-shelf software

  • Regular, consistent attendance

  • Varied hours as required


Special Requirements

  • Mandatory immunizations and screening

  • Ability to handle biological and radiolabeled materials

  • Must be able to distinguish colors and hear effectively


Benefits

Eligible employees (20+ hours/week) receive:

  • Medical, Dental, Vision insurance

  • Life, Short-Term & Long-Term Disability

  • 401(k)

  • Paid Time Off (PTO)

  • Employee recognition awards

  • Employee Resource Groups (ERGs)