The Steely Group ยท 9 hours ago
Director Clinical Research
United States
Part-time
Remote
Director/Executive
10+ years expThe Steely Group is seeking a Director of Clinical Research who will lead all clinical research activities. This role involves overseeing clinical trials, ensuring compliance with regulatory standards, and fostering partnerships with industry sponsors and academic institutions.
ConsultingHealth CareHuman ResourcesMedicalStaffing Agency
Hiring Manager
Linda Briscoe
Responsibilities
Lead the planning, design, and execution of multicenter clinical trials within Company reconstructive and regenerative surgery network
Ensure protocol adherence, regulatory compliance, and data integrity throughout the trial lifecycle
Oversee site selection, initiation, monitoring, and closure in collaboration with investigators and clinical operations staff
Ensure full compliance with FDA, IRB, and ICH-GCP standards for all sponsored and investigator-initiated studies
Oversee preparation and submission of regulatory documents including protocols, informed consent forms, safety reports, and clinical study reports
Maintain audit readiness and drive continuous improvement across research operations
Serve as the primary liaison between ARSA and industry sponsors, academic collaborators, CROs, and regulatory agencies
Strengthen strategic partnerships to expand Company clinical research capabilities and funding base
Support publication strategy and presentation of study outcomes at key academic and industry forums
Establish and manage a centralized research infrastructure across Company sites, promoting consistency and operational efficiency
Implement and maintain Standard Operating Procedures (SOPs) and Quality Management Systems (QMS) aligned with global best practices
Lead and mentor cross-functional research teams encompassing clinical operations, biostatistics, regulatory affairs, and data management
Drive a culture of accountability, quality, and scientific integrity across all clinical programs
Serve on Company research governance committee, contributing to long-term strategy and portfolio prioritization
Qualification
Required
MD, PhD, PharmD, or equivalent advanced degree in clinical research, life sciences, or related discipline
Minimum of 10 years of progressive leadership experience in clinical research operations, preferably within reconstructive surgery, wound healing, or medical device/biologics sectors
Demonstrated expertise in Quality Management Systems (QMS), clinical operations, and FDA/ICH-GCP regulatory compliance
Proven success managing multicenter trials and cross-functional research teams
Strong understanding of trial design, biostatistics, data management, and risk-based monitoring
Experience in submission processes for FDA, EMA, and IRB review
Familiarity with electronic data capture systems, clinical trial management systems, and audit processes
Ability to set a clinical research vision aligned with Company mission and growth objectives
Skilled in translating strategy into disciplined execution, with focus on timelines, budgets, and data quality
Deep understanding of global regulatory frameworks governing medical device and biologics research
Commitment to maintaining the highest standards of compliance, safety, and documentation
Builds strong partnerships across internal teams and external stakeholders to drive innovation and clinical value
Upholds ethical research principles and promotes transparency in reporting and publication
Company
The Steely Group
The Steely Group offers clinical, healthcare, and human resource recruitments and staffing solutions.
11-50 employees
Funding
Current Stage
Early StageLeadership Team
Giovanni Oriente
Chief Financial Officer
Jay VanHousen
Sr Director, Clinical and Scientific Partnerships
Recent News
2025-10-23
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