Cardiology Clinical Research Program Lead (Multi-Site)

Washington University in St. Louis; United States; On-site; USD 75,000 - 129,000; Full time

Job summary

Washington University in St. Louis is seeking a Senior Clinical Research Project Manager to oversee advanced operational planning, oversight, and strategy across complex, interdisciplinary studies spanning multiple departments and sites.

You will mentor junior staff, develop grant proposals, manage study budgets, and disseminate findings through publications and presentations while coordinating with sponsors, regulators, and external partners.

Qualifications

• Education: Bachelor’s degree or combination of education and/or experience may substitute for minimum education.
• Work Experience: Clinical Research And Program Management, Including Leadership And Management (5 Years), Supervisory (1 Year)
• Skills: Budget Management, Business Writing, Clinical Procedures, Clinical Research, Clinical Setting, Clinical Study Design, Communication, Confidentiality, Data Integrity, Flexible Mindset, Group Presentations, Medical Writing, Operational Execution

Responsibilities

• Leads the full scope of multiple concurrent, complex clinical research studies, ensuring studies are conducted according to the Code of federal Regulations, Good Clinical Practices, local regulatory requirements and Washington University SOPs.
• Serves as the primary operational lead and institutional representative for assigned studies, acting as the central point of contact for sponsors, regulatory agencies, and collaborative partners.
• Develops, implements, and continuously refines study-wide operational strategies, timelines, and quality frameworks in collaboration with PIs, co-investigators, and central research administration units.
• Maintains current knowledge of evolving domestic and international clinical research regulations and guidance documents; proactively conducts gap analyses to assess impact of regulatory changes; develops, implements, and monitors corrective systems, updated SOPs, and training initiatives to ensure sustained compliance across all sites.
• Demonstrates working knowledge of international clinical research regulations and guidelines; advises study teams on applicability and coordinates with regulators affairs as needed to ensure compliant conduct across jurisdictions.
• Leads investigator meetings, kick-off meetings, and cross-functional study team meetings; serves as the primary facilitator for complex multi-site coordination.
• Takes primary responsibility for protocol development, including drafting and finalizing study protocols, amendments, informed consent documents; reviews submissions prepared by junior staff.
• Leads feasibility assessments and contributes to grant proposals, including budget justifications, specific aims, and research strategies.
• Manages complex study budgets and funds independently, including oversight of subcontract budgets, reconciliation, forecasting, and reporting to funding agencies.
• Directs staffing planning for all assigned projects.
• Designs and leads comprehensive training programs for study teams across all performance sites and Cores/Components.
• Independently identifies, evaluates, and resolves complex study problems; develops corrective action plans from QA audits, regulatory inspections, or performance issues.
• Oversee internal quality control systems and conducts regular audits of study conduct, data quality, and regulatory documentation across the portfolio.
• Manages timelines and maintains project tracking systems; produces executive-level progress reports and presentations.
• Leads or co-leads manuscript preparation and dissemination of research results.
• Represents the institution at national investigator meetings and sponsor communications; builds external relationships.
• Performs other duties incidental to the work described above.
• Demonstrates confidence in presentation skills.

Skills

Budget Management

Business Writing

Clinical Procedures

Clinical Research

Clinical Setting

Clinical Study Design

Communication

Confidentiality

Data Integrity

Flexible Mindset

Group Presentations

Medical Writing

Operational Execution

Education

Bachelore20s degree

Job description

Washington University in St. Louis is seeking a Senior Clinical Research Project Manager to oversee advanced operational planning, oversight, and strategy across complex, interdisciplinary studies spanning multiple departments and sites.

You will mentor junior staff, develop grant proposals, manage study budgets, and disseminate findings through publications and presentations while coordinating with sponsors, regulators, and external partners.