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)
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
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Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Canada |Quebec :
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Brazil | Sao paulo |Attica :
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Auckland |New Zealand :
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Madrid |Cebu Province :
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Croatia |Zagreb :
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Japan | Saitama |Tokyo :
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Kyiv |Lima Region :
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