Associate Director, Regional Clinical Study Management
New
J
JobgetherClinical research
Based in the United StatesFull-TimeDirector
SalaryCompetitive annual base salary of $143,300–$193,300
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Job Details
- Experience
- 8+ years of progressive clinical operations experience; alternatively, a preferred master’s degree with 6+ years of relevant experience.
- Required Skills
- Microsoft OfficeBudget managementRisk Management
Requirements
- Hold a bachelor’s degree in a scientific or healthcare discipline.
- Have 8+ years of progressive clinical operations experience in the biotechnology, pharmaceutical, or CRO industry; alternatively, a preferred master’s degree with 6+ years of relevant experience.
- Bring leadership and management experience as a direct people manager or cross-functional clinical study leader.
- Have experience managing regional clinical studies or portfolios across planning, startup, recruitment, execution, quality, and closeout.
- Demonstrate knowledge of clinical research operations, ICH/GCP, regulatory requirements, inspection readiness, study quality, and risk management.
- Have experience managing external vendors, regional budgets, resources, investigator/site payments, and other clinical study operations.
- Be able to lead cross-functional teams, influence stakeholders, make decisions, and resolve complex operational challenges independently.
- Have strong written and verbal communication, organizational, and prioritization skills.
- Be proficient with Microsoft Office and project planning applications.
- Demonstrate analytical thinking, data analysis, initiative, adaptability, and a collaborative approach to developing others.
Responsibilities
- Lead regional clinical operations for assigned studies or portfolios, set goals, drive decisions, and resolve escalated issues.
- Oversee regional study delivery from feasibility and startup through recruitment, execution, data collection, and closeout.
- Drive regional feasibility, country allocation, site selection, startup planning, recruitment timelines, regulatory submissions, and local adaptation of study documentation.
- Coordinate internal clinical teams, cross-functional stakeholders, and external vendors; provide study updates and escalate risks.
- Monitor study performance and ensure compliance with protocols, SOPs, ICH/GCP requirements, applicable regulations, and inspection-readiness standards.
- Identify operational risks and quality concerns, implement corrective solutions, and prepare sites and teams for audits and regulatory inspections.
- Guide CRA coaching and mentoring, support monitoring quality, and oversee Trial Master File documentation quality.
- Support clinical data collection, data entry, query resolution, clinical supplies planning, comparator drug considerations, and Clinical Study Report activities.
- Select and manage regional vendors, monitor budgets and resource utilization, and coordinate investigator fees, site payments, and patient reimbursement.
- Develop regional processes, tools, work instructions, and SOPs; mentor team members and travel as needed to support business and study requirements.
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