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guidelines, and regulatory requirements. Prepare for, participate in, and manage sponsor monitoring visits, internal audits, and regulatory inspections. Implement corrective and preventive actions (CAPA) as required. Standardize, update, and implement institutional SOPs across assigned regional hubs. 5. Vendor, Administrative Management Manage cross-departmental collaboration with Regulatory, Data, and QA leadership. Serve as the primary point of contact and manage relationships with external stakeholders, including sponsors, CROs, central labs, and regulatory authorities. Maintain and oversee trial management systems (CTMS) and electronic trial master files (eTMF). Prepare, synthesize, and distribute periodic operational metrics and site performance reports for executive leadership. 6. Essential Functions Perform and oversee all aspects of clinical trial operations from study start-up through closeout. Maintain proficiency in Clinical Research Coordinator (CRC) responsibilities and perform CRC duties as needed to support study operations. Conduct or assist with participant screening, informed consent, study visits, source documentation, investigational product accountability, specimen processing, and data entry. Provide operational support during staffing shortages, vacations, high enrollment periods, or other business needs. Ensure compliance with study protocols, FDA regulations, ICH-GCP guidelines, sponsor requirements, and company SOPs. Supervise, mentor, and evaluate clinical research staff. Travel between assigned sites as needed to support operations. Lift and transport study supplies, investigational product, and laboratory specimens (up to __ lbs., if applicable). Perform other related clinical research and operational duties as assigned by management.

Qualifications Education Required:

Bachelor's degree in a scientific discipline, Life Sciences, Healthcare, or a related field to inform clinical decision-making.

Preferred:

Advanced degree (Master's, Ph.D., or equivalent) preferred.

Experience Required:

Minimum of 7-10 years of experience in clinical trial management or clinical research.

Required Management Experience:

At least 3 years in a direct management/leadership capacity leading multi-site or multi-study portfolios.

Preferred Background:

Experience working within a Site Management Organization (SMO), clinical research site, CRO, or pharmaceutical sponsor environment.

Skills & Competencies Regulatory Expertise:

Deep knowledge of FDA regulations, ICH guidelines, and GCP standards.

Technical Proficiency:

Highly proficient in using Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC) systems, and electronic Trial Master Files (eTMF).

Leadership & Communication:

Exceptional communication, interpersonal, and cross-functional collaboration skills; proven ability to mentor, train, and lead diverse teams.

Project Management:

Excellent organizational, budget tracking, and project management skills with the ability to work independently. Preferred Credentials Relevant professional credentials/certifications are highly desirable (e.g., CCRC, CCRP, PMP, or RAC). . Working Conditions Office environment with potential exposure to clinical settings. Regional travel required for site visits, sponsor meetings, and training. .

Location:

Full Time On-site (this is a non-remote or hybrid position)

Compensation:

$28-$40 per hour

Benefits:

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