Lead Clinical Study Manager

5 days ago

🌲 North Carolina – Remote

Although this job is listed in North Carolina, this company may be open to hiring remote in other states.

💵 $121k - $148k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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RTI International

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RTI International is an independent scientific research institute dedicated to improving the human condition through diverse services and capabilities, including public health, education, and environmental sciences. They partner with the U. S. government, universities, and various organizations to conduct research and provide solutions in areas such as health care quality, economic development, energy efficiency, and innovation in multiple sectors. RTI focuses on evidence-based strategies and data-driven solutions to address critical global challenges.

health research • drug discovery and development • education research • social and economic policy research • surveys and statistics

5001 - 10000 employees

Founded 1958

⚕️ Healthcare Insurance

📚 Education

🔬 Science

📋 Description

• The ideal candidate will be highly motivated, results-oriented, and collaborative with experience leading multi-site clinical trial operations and drug development initiatives. • The Senior CLS will serve as the operational lead for clinical trials, including study planning, budget and resource management, and oversight of project vendors and subcontractors, as applicable. • Focused on operational excellence, this person will work closely with Project Leadership to lead a cross-functional study team to ensure the timely conduct of high-quality clinical trials in accordance with study protocols, Good Clinical Practice, Standard Operating Procedures, and applicable regulations.

🎯 Requirements

• Bachelor's Degree and 10 years of experience, Master's degree and 8 years of experience, PhD and 6 years of experience, or equivalent combination of education and experience. • Relevant clinical research certifications (e.g., CCRA, CCRP) preferred but not required. • Strong knowledge of clinical trial drug development processes, clinical trial study design, planning and management, and monitoring. • 4+ years of clinical trials experience, including CRA/field monitor in pharmaceutical, biotech or CRO setting; 2 + years with a sponsor organization a plus. • Minimum of 4 years in planning, launching, monitoring, and closeout of Phase 1-3 clinical trials conducted under INDs. • Strong knowledge of CFR, ICH, GCP and GDPR/data privacy requirements. • Experience with industry standard clinical trial data management systems and platforms. • Ability to review and analyze performance metrics through various systems for assigned areas of responsibility. • Strong problem-solving skills with ability to anticipate issues and respond strategically. • Experience and competence in developing and delivering effective presentations in multidisciplinary settings. • Excellent interpersonal and communications skills. • Self-starter, effective working in a hybrid work environment with colleagues and vendors in different geographies. • Strong attention to detail, and organizational and time management skills.

🏖️ Benefits

• Competitive base salary • Generous paid time off policy • Merit based annual increases • Bonus opportunities • Robust recognition program • Competitive range of insurance plans (health, dental, life, etc.) • Access to a retirement savings program (401(k) plan) • Paid parental leave for all parents • Financial assistance with adoption expenses or infertility treatments • Financial reimbursement for education and developmental opportunities • Employee assistance program • Numerous other offerings to support work-life balance