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Clinical Operations Supervisor Ii / Dallas, Tx (On-Site)

3-5 years
Not Disclosed
10 Oct. 6, 2025
Job Description
Job Type: Full Time Remote 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

Job Title:

Clinical Operations Supervisor II

Location: Dallas, TX (On-Site)
Category: Clinical
Job ID: 254595


Job Overview

The Clinical Operations Supervisor II is responsible for overseeing practical aspects of clinical studies, ensuring adherence to protocols, SOPs, and ICH/GCP standards. This role includes leadership, training, coaching, and mentoring of clinical staff while interacting directly with study participants. The position exposes staff to a variety of therapeutic indications and early-phase study types, including ascending dose, first-in-human, food effect, and drug-drug interaction studies.


Primary Responsibilities

Clinical Oversight & Quality:

  • Ensure all clinical study activities are conducted to the highest quality standards in accordance with protocol, SOPs, and ICH/GCP.

  • Maintain up-to-date data records and ensure CRFs meet customer expectations.

  • Coordinate protocol-related procedures and study setup planning as needed.

  • Track and evaluate key performance indicators and implement continuous improvement initiatives.

  • Ensure a safe working environment and adherence to safety practices.

Leadership & Staff Management:

  • Directly supervise clinical staff including RNs, LVN/LPNs, and Research Technicians.

  • Provide leadership, training, coaching, and mentoring to team members.

  • Perform supervisory duties including interviewing, hiring, training, intervention, discipline, and discharge of operations staff.

  • Ensure staff are adequately trained and maintain complete training files according to SOPs and ICH/GCP.

  • Schedule staff and investigators for protocol-related tasks.

  • Drive staff development programs and ensure team adherence to quality standards.

Compliance & Process Improvement:

  • Respond constructively to management and QA to address GCP/ICH deficiencies.

  • Update or create SOPs/Policies and Procedures relevant to the area of expertise.

  • Recommend and justify operational changes in accordance with company policy.

  • Continuously identify best practices and drive process improvements.


Qualifications / Skills

Minimum Required:

  • BS in Science or Medical field, or LPN, LVN, or AD degree.

  • 3–5 years of people management/direct reports experience.

  • Current knowledge of ICH/GCP standards.

  • Mandatory immunizations and screening as required.

  • Ability to handle biologically hazardous and radiolabeled material.

  • Excellent English communication skills, both written and verbal.

  • Ability to stand, bend, and use hands for up to 6 hours per day.

  • Ability to work overtime and weekends as needed.

Preferred:

  • Six Sigma Green Belt certification.

  • Additional experience may be substituted for education.


Work Environment & Culture

  • Fast-paced environment requiring strict adherence to study protocols and timelines.

  • Constantly changing priorities requiring adaptability.

  • Strong emphasis on teamwork and people skills.

  • Technology-driven, with direct electronic data capture.


Benefits

  • Comprehensive benefits for full-time or part-time employees (20+ hours/week), including:

    • Medical, Dental, Vision, Life, STD/LTD insurance (multiple carriers)

    • 401(K) plan

    • Paid Time Off (PTO)

    • Employee recognition awards

    • Multiple Employee Resource Groups (ERGs)