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Evolution Research Group · 3 weeks ago

Director/Manager of Clinical Operations-Onsite in Miami, FL

San Antonio, TX

Full-time

Onsite

Senior Level, Lead/Staff, Director/Executive

7+ years exp

Evolution Research Group is a leading clinical research site company specializing in early and late-stage neuroscience drug development. They are seeking a highly qualified Manager/Director of Clinical Operations to oversee clinical trials, ensuring protocol adherence, and managing both staff and operational aspects of studies.

AssociationBiotechnologyGovernmentHealth CareLife Science

Responsibilities

Lead and mentor the clinical operations team to promote a collaborative and efficient environment

Ensure protocol compliance and maintain high-quality standards across studies

Collaborate closely with Principal Investigators and Site Directors to assign studies and develop enrollment strategies

Oversee human resources functions, including staff evaluations, recruitment, and training

Monitor adherence to protocols, reporting any deviations to sponsors and regulatory bodies

Coordinate with Site Director and Principal Investigator to assign primary clinical research coordinators

Review study components with Principal Investigators and Site Directors, identifying areas requiring clarification before study initiation

Conduct study closeout procedures

Perform additional duties as needed to adapt to the evolving needs of CPMI

Ensure compliance with all applicable regulations and guidelines, including FDA, ICH, and GCP

Qualification

Clinical operations managementFDA regulations knowledgeGCP complianceICH guidelines knowledgeClinical trial operationsClinical management softwareTeam managementBilingual in EnglishSpanishCommunication skillsOrganizational skillsLeadership skills

Required

Bachelor's degree in a scientific or healthcare-related field

7-10 years of experience in clinical operations, including 5+ years in a senior leadership role

Strong understanding of FDA, ICH, and GCP regulations and guidelines

Strong communication, organizational, and leadership skills

Ability to travel as needed and proficiency in Microsoft Word, Excel, and clinical management software

In-depth knowledge of clinical trial operations, including study start-up, site selection, patient recruitment, monitoring, data management, and study close-out

Experience managing and mentoring a team of clinical operations professionals